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    Clinical Trial Results:
    A randomised, double-blind, double-dummy, 4-week treatment, parallel-group study to evaluate the efficacy and safety of two doses of mometasone furoate delivered via Concept1 or Twisthaler® in adult and adolescent patients with persistent asthma

    Summary
    EudraCT number
    		 2011-005100-14
    Trial protocol
    		 HU   SK   EE   LT   NL   LV   DE   BE  
    Global end of trial date
    02 Jul 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    17 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CQMF149E2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01555151
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001217-PIP01-11
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Jul 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the efficacy of two different doses (80 micrograms [mcg] and 320 mcg) of Mometasone furoate (MF) delivered via a single dose dry powder inhaler (Concept 1) compared to 200 mcg and 800 mcg of MF delivered via multidose dry powder inhaler device (Twisthaler) during treatment period of 28 days.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed. In addition, all subjects enrolled in the trial were supplied with an inhaled SABA (Salbutamol/Albuterol) as rescue medication.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jul 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Japan: 74
    Country: Number of subjects enrolled
    India: 46
    Country: Number of subjects enrolled
    Malaysia: 5
    Country: Number of subjects enrolled
    Thailand: 27
    Country: Number of subjects enrolled
    Estonia: 9
    Country: Number of subjects enrolled
    Lithuania: 24
    Country: Number of subjects enrolled
    Latvia: 19
    Country: Number of subjects enrolled
    Poland: 49
    Country: Number of subjects enrolled
    Russian Federation: 40
    Country: Number of subjects enrolled
    Ukraine: 90
    Country: Number of subjects enrolled
    Canada: 13
    Country: Number of subjects enrolled
    Germany: 60
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Hungary: 180
    Country: Number of subjects enrolled
    Slovakia: 88
    Country: Number of subjects enrolled
    Turkey: 7
    Worldwide total number of subjects
    739
    EEA total number of subjects
    437
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    73
    Adults (18-64 years)
    595
    From 65 to 84 years
    71
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 141 centres in 17 countries.

    Pre-assignment
    Screening details
    		 A total of 1621 subjects were screened for the study, out of which 739 subjects completed the screening while 882 discontinued the study during the screening phase.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    A double-dummy design was used because the identity of the study drugs could not be disguised due to their different forms. Unblinding was allowed only in case of subjects emergencies and at the conclusion of the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Mometasone Furoate 80 mcg via the Concept1 Device
    Arm description
    		 MF delivered via Concept1, 80 mcg once daily (o.d.) in the evening
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone Furoate (Concept1)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    MF 80 mcg o.d. dose delivered via Concept1, plus placebo via Twisthaler

    Arm title
    		 Mometasone Furoate 200 mcg via the Twisthaler Device
    Arm description
    		 MF delivered via Twisthaler, 200 mcg o.d. in the evening
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mometasone Furoate (Twisthaler)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    MF 200 mcg od dose delivered via Twisthaler , plus placebo via Concept1

    Arm title
    		 Mometasone Furoate 320 mcg via the Concept1 Device
    Arm description
    		 MF delivered via Concept1, 320 mcg o.d. in the evening
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone Furoate (Concept1)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    MF 320 mcg o.d. delivered via Concept1, plus placebo via Twisthaler

    Arm title
    		 Mometasone Furoate 800 mcg via the Twisthaler Device
    Arm description
    		 MF delivered via Twisthaler, 800 mcg o.d. in the evening
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mometasone Furoate (Twisthaler)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    MF 800 mcg o.d. dose delivered via Twisthaler, plus placebo via Concept1

    Number of subjects in period 1
    		Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Started
    188
    181
    184
    186
    Completed
    175
    173
    178
    176
    Not completed
    13
    8
    6
    10
         Consent withdrawn by subject
    6
    2
    -
    2
         Adverse event, non-fatal
    1
    2
    1
    2
         Administrative problem
    3
    1
    2
    -
         Lost to follow-up
    -
    -
    -
    1
         Protocol deviation
    3
    3
    3
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mometasone Furoate 80 mcg via the Concept1 Device
    Reporting group description
    		 MF delivered via Concept1, 80 mcg once daily (o.d.) in the evening

    Reporting group title
    Mometasone Furoate 200 mcg via the Twisthaler Device
    Reporting group description
    		 MF delivered via Twisthaler, 200 mcg o.d. in the evening

    Reporting group title
    Mometasone Furoate 320 mcg via the Concept1 Device
    Reporting group description
    		 MF delivered via Concept1, 320 mcg o.d. in the evening

    Reporting group title
    Mometasone Furoate 800 mcg via the Twisthaler Device
    Reporting group description
    		 MF delivered via Twisthaler, 800 mcg o.d. in the evening

    Reporting group values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device Total
    Number of subjects
    		 188 181 184 186 739
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 22 18 16 17 73
        Adults (18-64 years)
    		 148 148 146 153 595
        Adults (65-<85 years)
    		 18 15 22 16 71
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.4 ( 16.33 ) 45.9 ( 15.56 ) 46 ( 16.18 ) 45.5 ( 16.57 ) -
    Gender categorical
    Units: Subjects
        Female
    		 98 94 113 97 402
        Male
    		 90 87 71 89 337

    End points

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    End points reporting groups
    Reporting group title
    Mometasone Furoate 80 mcg via the Concept1 Device
    Reporting group description
    		 MF delivered via Concept1, 80 mcg once daily (o.d.) in the evening

    Reporting group title
    Mometasone Furoate 200 mcg via the Twisthaler Device
    Reporting group description
    		 MF delivered via Twisthaler, 200 mcg o.d. in the evening

    Reporting group title
    Mometasone Furoate 320 mcg via the Concept1 Device
    Reporting group description
    		 MF delivered via Concept1, 320 mcg o.d. in the evening

    Reporting group title
    Mometasone Furoate 800 mcg via the Twisthaler Device
    Reporting group description
    		 MF delivered via Twisthaler, 800 mcg o.d. in the evening

    Primary: Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29

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    End point title
    		 Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
    End point description
    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23 hour (hr) 15 minute (min) and 23hr 45min post dosing. The analysis was performed for Full Analysis Set (FAS), defined as all randomised subjects who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Day 29
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    171
    165
    172
    173
    Units: Liters
        least squares mean (standard error)
    2.139 ( 0.0281 )
    2.071 ( 0.0283 )
    2.187 ( 0.0281 )
    2.162 ( 0.0279 )
    Statistical analysis title
    		 Trough Forced Expiratory Volume in 1 Second (FEV1)
    Comparison groups
    Mometasone Furoate 80 mcg via the Concept1 Device v Mometasone Furoate 200 mcg via the Twisthaler Device
    Number of subjects included in analysis
    336
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean
    Point estimate
    0.068
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 0
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0349
    Statistical analysis title
    		 Trough Forced Expiratory Volume in 1 Second (FEV1)
    Comparison groups
    Mometasone Furoate 320 mcg via the Concept1 Device v Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects included in analysis
    345
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean
    Point estimate
    0.025
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -0.0427
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0342

    Secondary: Trough Forced Expiratory Volume in 1 Second (FEV1) for dose discrimination at Day 29

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    End point title
    		 Trough Forced Expiratory Volume in 1 Second (FEV1) for dose discrimination at Day 29
    End point description
    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23hr 10min and 23hr 45min post dosing. Analysis was performed in FAS population.
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    171
    165
    172
    173
    Units: litre(s)
        least squares mean (standard error)
    2.139 ( 0.0281 )
    2.071 ( 0.0283 )
    2.187 ( 0.0281 )
    2.162 ( 0.0279 )
    Statistical analysis title
    		 FEV1 dose discrimination
    Comparison groups
    Mometasone Furoate 80 mcg via the Concept1 Device v Mometasone Furoate 320 mcg via the Concept1 Device
    Number of subjects included in analysis
    343
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.167
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean
    Point estimate
    0.048
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.1157
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0346
    Statistical analysis title
    		 FEV1 dose discrimination
    Comparison groups
    Mometasone Furoate 800 mcg via the Twisthaler Device v Mometasone Furoate 200 mcg via the Twisthaler Device
    Number of subjects included in analysis
    338
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.008
    Method
    		 Mixed models analysis
    Parameter type
    		 Least square mean
    Point estimate
    0.092
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.0235
         upper limit
    		 0.1599
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0347

    Secondary: Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 15 and 22 of treatment

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    End point title
    		 Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 15 and 22 of treatment
    End point description
    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23hr 10min and 23hr 45min post dosing. Analysis was performed in FAS population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Days 8, 15 and 22
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    179
    173
    181
    181
    Units: litre(s)
    least squares mean (standard error)
        Day 8 (n=178,173,181,181)
    2.069 ( 0.0252 )
    2.057 ( 0.0253 )
    2.113 ( 0.0251 )
    2.111 ( 0.025 )
        Day 15 (n=179,171,177,178)
    2.095 ( 0.0254 )
    2.048 ( 0.0258 )
    2.134 ( 0.0257 )
    2.135 ( 0.0255 )
        Day 22 (n=174,170,177,177)
    2.126 ( 0.0284 )
    2.071 ( 0.0286 )
    2.175 ( 0.0283 )
    2.146 ( 0.0282 )
    No statistical analyses for this end point

    Secondary: Forced Vital Capacity (FVC)

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    End point title
    		 Forced Vital Capacity (FVC)
    End point description
    Forced Vital Capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest possible breath. Analysis was performed in FAS population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Pre dose (50 min and 15 min) and post dose (30 min, 1 hr, 23 hr 10 min and 23 hr 45 min) at Day 1, 8, 15, 22, 28 and 29
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    178
    172
    179
    175
    Units: litre(s)
    least squares mean (standard error)
        Day 1/30 min post-dose (n=172,172,175,173)
    2.892 ( 0.0208 )
    2.893 ( 0.0207 )
    2.861 ( 0.0209 )
    2.897 ( 0.0208 )
        Day 1/1 hr post-dose (n=178,169,174,175)
    2.93 ( 0.0234 )
    2.913 ( 0.0234 )
    2.943 ( 0.0238 )
    2.946 ( 0.0235 )
        Day 8/50 min pre-dose (n=174,171,179,175)
    3.111 ( 0.0325 )
    3.096 ( 0.0325 )
    3.134 ( 0.0321 )
    3.139 ( 0.0324 )
        Day 8/15 min pre-dose (n=176,172,179,174)
    3.099 ( 0.0324 )
    3.074 ( 0.0324 )
    3.121 ( 0.0321 )
    3.125 ( 0.0323 )
        Day 15 /50 min pre-dose (n=176,169,170,169)
    3.134 ( 0.0342 )
    3.09 ( 0.0347 )
    3.168 ( 0.0348 )
    3.155 ( 0.0348 )
        Day 15/15 min pre-dose (n=176,168,176,167)
    3.709 ( 0.0343 )
    3.076 ( 0.0348 )
    3.137 ( 0.0345 )
    3.127 ( 0.0348 )
        Day 22/50 min pre-dose (n=172,167,174,169)
    3.136 ( 0.0356 )
    3.091 ( 0.0359 )
    3.203 ( 0.0355 )
    3.152 ( 0.0357 )
        Day 22/15 min pre-dose (n=169,170,174,172)
    3.134 ( 0.0365 )
    3.096 ( 0.0363 )
    3.198 ( 0.0362 )
    3.157 ( 0.0361 )
        Day 28/50 min pre-dose (n=172,168,176,172)
    3.146 ( 0.0342 )
    3.115 ( 0.0345 )
    3.184 ( 0.034 )
    3.18 ( 0.0342 )
        Day 28/15 min pre-dose (n=170,165,174, 170)
    3.135 ( 0.0345 )
    3.095 ( 0.0348 )
    3.153 ( 0.0343 )
    3.161 ( 0.0344 )
        Day 28/30 min post-dose (n=175,166,174,170)
    3.132 ( 0.0341 )
    3.092 ( 0.0346 )
    3.151 ( 0.0343 )
    3.184 ( 0.0343 )
        Day 28/30 min post-dose (n=173,167,172,172)
    3.14 ( 0.0351 )
    3.084 ( 0.0353 )
    3.158 ( 0.0353 )
    3.161 ( 0.035 )
        Day 29/23hr 10 min post-dose (n=173,162,172,168)
    3.16 ( 0.0342 )
    3.113 ( 0.0348 )
    3.216 ( 0.0343 )
    3.194 ( 0.0344 )
        Day 29/23hr 45 min post-dose (n=172,161, 175,170)
    3.165 ( 0.0355 )
    3.09 ( 0.0363 )
    3.192 ( 0.0353 )
    3.158 ( 0.0355 )
    No statistical analyses for this end point

    Secondary: Forced Expiratory Flow Between 25% and 75% (FEF 25-75%)

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    End point title
    		 Forced Expiratory Flow Between 25% and 75% (FEF 25-75%)
    End point description
    FEF (25%-75%) measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the FVC test and is measured using spirometry. Analysis was performed in FAS population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Pre dose (50 min and 15 min) and post dose (30 min, 1 hr, 23 hr 10 min and 23 hr 45 min) at Day 1, 8, 15, 22, 28 and 29
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    178
    172
    179
    174
    Units: litre(s) per second
    least squares mean (standard error)
        Day 1/30 min post-dose (n=172,172,175,172)
    1.308 ( 0.0181 )
    1.3 ( 0.0182 )
    1.309 ( 0.0182 )
    1.308 ( 0.0182 )
        Day 1/1 hr post-dose (n=178,169,174,174)
    1.337 ( 0.0197 )
    1.327 ( 0.0201 )
    1.316 ( 0.0201 )
    1.345 ( 0.0199 )
        Day 8/50 min pre-dose (n=173,171,179,174)
    1.457 ( 0.0323 )
    1.449 ( 0.0322 )
    1.519 ( 0.0317 )
    1.525 ( 0.0321 )
        Day 8/15 min pre-dose (n=175,172,179,173)
    1.458 ( 0.0329 )
    1.466 ( 0.0328 )
    1.542 ( 0.0325 )
    1.566 ( 0.0328 )
        Day 15 /50 min pre-dose (n=175,169,170,169)
    1.509 ( 0.0317 )
    1.43 ( 0.0321 )
    1.514 ( 0.032 )
    1.544 ( 0.0321 )
        Day 15/15 min pre-dose (n=175,168,176,167)
    1.494 ( 0.0322 )
    1.414 ( 0.0326 )
    1.52 ( 0.0321 )
    1.561 ( 0.0327 )
        Day 22/50 min pre-dose (n=171,167,174,169)
    1.511 ( 0.035 )
    1.44 ( 0.0353 )
    1.565 ( 0.0348 )
    1.555 ( 0.0351 )
        Day 22/15 min pre-dose (n=168,170,174,172)
    1.54 ( 0.0365 )
    1.476 ( 0.0362 )
    1.6 ( 0.0361 )
    1.591 ( 0.0361 )
        Day 28/50 min pre-dose (n=171,168,176,172)
    1.504 ( 0.0353 )
    1.458 ( 0.0354 )
    1.581 ( 0.035 )
    1.598 ( 0.0351 )
        Day 28/15 min pre-dose (n=169,165,174, 170)
    1.529 ( 0.0357 )
    1.481 ( 0.0359 )
    1.574 ( 0.0354 )
    1.584 ( 0.0355 )
        Day 28/30 min post-dose (n=175,166,174,170)
    1.558 ( 0.0362 )
    1.457 ( 0.0368 )
    1.557 ( 0.0364 )
    1.615 ( 0.0364 )
        Day 28/30 min post-dose (n=172,167,172,172)
    1.566 ( 0.0367 )
    1.46 ( 0.0369 )
    1.557 ( 0.0368 )
    1.593 ( 0.0365 )
        Day 29/23hr 10 min post-dose (n=172,162,172,168)
    1.537 ( 0.0369 )
    1.451 ( 0.0376 )
    1.604 ( 0.0369 )
    1.584 ( 0.0371 )
        Day 29/23hr 45 min post-dose (n=171,161, 175,170)
    1.55 ( 0.037 )
    1.438 ( 0.0378 )
    1.576 ( 0.0366 )
    1.571 ( 0.0369 )
    No statistical analyses for this end point

    Secondary: Forced Expiratory Volume in 1 second (FEV1) as Percentage of Forced Vital Capacity (FVC)

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    End point title
    		 Forced Expiratory Volume in 1 second (FEV1) as Percentage of Forced Vital Capacity (FVC)
    End point description
    Percentage of FEV1 is calculated as (FEV1/FVC)*100. It signifies the percentage of the total amount of air exhaled from the lungs during the first second of forced exhalation. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Analysis was performed in FAS population. The, 'n' signifies those subjects evaluable for this measure at specified time points for each group.
    End point type
    Secondary
    End point timeframe
    Pre dose (50 min and 15 min) and post dose (30 min, 1 hr, 23 hr 10 min and 23 hr 45 min) at Day 1, 8, 15, 22, 28 and 29
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    178
    172
    179
    175
    Units: percent
    least squares mean (standard error)
        Day 1/30 min post-dose (n=172,172,175,173)
    65.043 ( 0.2548 )
    64.898 ( 0.2556 )
    65.184 ( 0.2559 )
    64.898 ( 0.2554 )
        Day 1/1 hr post-dose (n=178,169,174,175)
    65.177 ( 0.2833 )
    64.833 ( 0.289 )
    65.005 ( 0.2885 )
    65.072 ( 0.2845 )
        Day 8/50 min pre-dose (n=174,171,179,175)
    66.566 ( 0.4281 )
    66.301 ( 0.4286 )
    67.344 ( 0.4222 )
    66.568 ( 0.4264 )
        Day 8/15 min pre-dose (n=176,172,179,174)
    66.595 ( 0.4259 )
    66.79 ( 0.4262 )
    67.778 ( 0.4224 )
    67.156 ( 0.4252 )
        Day 15 /50 min pre-dose (n=176,169,170,169)
    67.007 ( 0.4329 )
    66.122 ( 0.4398 )
    67.487 ( 0.4395 )
    67.139 ( 0.4407 )
        Day 15/15 min pre-dose (n=176,168,176,167)
    66.878 ( 0.437 )
    66.006 ( 0.4443 )
    67.607 ( 0.4384 )
    67.514 ( 0.4456 )
        Day 22/50 min pre-dose (n=172,167,174,169)
    67.081 ( 0.4594 )
    66.567 ( 0.4643 )
    67.831 ( 0.4584 )
    67.742 ( 0.4615 )
        Day 22/15 min pre-dose (n=169,170,174,172)
    67.403 ( 0.4657 )
    66.885 ( 0.4629 )
    68.143 ( 0.4622 )
    67.895 ( 0.4612 )
        Day 28/50 min pre-dose (n=172,168,176,172)
    67.128 ( 0.4584 )
    66.835 ( 0.4615 )
    68.124 ( 0.4567 )
    67.81 ( 0.4578 )
        Day 28/15 min pre-dose (n=170,165,174, 170)
    67.503 ( 0.4813 )
    67.296 ( 0.4854 )
    68.255 ( 0.4796 )
    67.878 ( 0.4804 )
        Day 28/30 min post-dose (n=175,166,174,170)
    67.7 ( 0.4723 )
    67.013 ( 0.4796 )
    68.031 ( 0.4755 )
    68.126 ( 0.4755 )
        Day 28/30 min post-dose (n=173,167,172,172)
    67.945 ( 0.4703 )
    66.832 ( 0.4741 )
    68.243 ( 0.4736 )
    68.057 ( 0.4698 )
        Day 29/23hr 10 min post-dose (n=173,162,172,168)
    67.427 ( 0.4639 )
    66.711 ( 0.4736 )
    68.265 ( 0.4654 )
    67.592 ( 0.4676 )
        Day 29/23hr 45 min post-dose (n=172,161, 175,170)
    67.63 ( 0.4694 )
    66.541 ( 0.4806 )
    67.961 ( 0.4667 )
    67.831 ( 0.4692 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Day 28

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    End point title
    		 Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Day 28
    End point description
    The PEFR is a subject's maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEFR was performed every morning and evening. Analysis was performed in FAS population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 28
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    177
    172
    175
    182
    Units: litres per min
    least squares mean (standard error)
        Morning PEFR (n=177,171, 175, 182)
    -4.952 ( 4.1929 )
    3.955 ( 4.2616 )
    2.785 ( 4.2349 )
    1.606 ( 4.1464 )
        Evening PEFR (n=176, 172, 174, 179)
    1.354 ( 3.9003 )
    0.293 ( 3.9477 )
    -0.644 ( 3.9427 )
    6.287 ( 3.8826 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Asthma Control Questionnaire (ACQ-5) at Day 8, 15, 22, and 29

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    End point title
    		 Change From Baseline in Asthma Control Questionnaire (ACQ-5) at Day 8, 15, 22, and 29
    End point description
    Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 is comprised of five questions of the asthma symptoms to be answered by the subject. The overall score is the average of the 5 questions; a minimum overall score of 0 (good control of asthma) whereas a maximum overall score of 6 (poor control of asthma). A negative change in score indicates improvement in asthma symptoms. Analysis was performed in FAS population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 8, 15, 22 and 29
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    180
    176
    182
    182
    Units: Units on a scale
    least squares mean (standard error)
        Change from baseline at day 8 (n=179,176,182,182)
    -0.662 ( 0.0543 )
    -0.73 ( 0.0546 )
    -0.908 ( 0.054 )
    -0.89 ( 0.0538 )
        Change from baseline at day 15 (n=180,174,179,178)
    -0.899 ( 0.059 )
    -0.908 ( 0.0599 )
    -1.117 ( 0.0595 )
    -0.973 ( 0.0593 )
        Change from baseline at day 22 (n=178,173,178,177)
    -0.994 ( 0.062 )
    -0.982 ( 0.0628 )
    -1.262 ( 0.0622 )
    -1.097 ( 0.0622 )
        Change from baseline at day 29 (n=179,176,181,182)
    -1.079 ( 0.063 )
    -1.109 ( 0.0635 )
    -1.329 ( 0.0632 )
    -1.162 ( 0.0625 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication at Day 28

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    End point title
    		 Change From Baseline in Mean Daily Number of Puffs of Rescue Medication at Day 28
    End point description
    Mean daily number of puffs of rescue medication taken for the subject was derived from total number of puffs of rescue medication utilised per day over the 28 days treatment period divided by the total number of days with non-missing rescue medication data. Analysis was performed in FAS population.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 28
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    177
    172
    175
    181
    Units: Number of puffs
        least squares mean (standard error)
    -0.456 ( 0.0972 )
    -0.391 ( 0.0985 )
    -0.6 ( 0.0981 )
    -0.677 ( 0.0963 )
    No statistical analyses for this end point

    Secondary: Percentage of days with no use of rescue medication

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    End point title
    		 Percentage of days with no use of rescue medication
    End point description
    A day with no rescue use was defined as any day where the subject did not use any puffs of rescue medication. Percentage of days with no rescue use was derived from total number of days with no rescue use during 28 days treatment period divided by the total number of evaluable days.
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    124
    116
    117
    113
    Units: percentage days
        least squares mean (standard error)
    74.148 ( 2.2576 )
    75.236 ( 2.3291 )
    75.157 ( 2.3044 )
    80.578 ( 2.3476 )
    No statistical analyses for this end point

    Secondary: Fractional Exhaled Nitric Oxide (FeNO)

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    End point title
    		 Fractional Exhaled Nitric Oxide (FeNO)
    End point description
    FeNO is widely accepted as a non-invasive marker for airway inflammation in asthma. Analysis was performed in FAS population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Day 15 and 29
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    142
    143
    145
    150
    Units: ppm
    arithmetic mean (standard error)
        Day 15 (n= 142, 139, 139, 149)
    25.286 ( 1.2983 )
    26.762 ( 1.3201 )
    19.098 ( 1.3246 )
    21.017 ( 1.2911 )
        Day 29 (n=141, 143, 145, 150)
    23.777 ( 1.3078 )
    27.055 ( 1.3035 )
    18.468 ( 1.2952 )
    19.981 ( 1.2803 )
    No statistical analyses for this end point

    Secondary: Change from baseline in plasma cortisol concentrations at Day 1 and 28

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    End point title
    		 Change from baseline in plasma cortisol concentrations at Day 1 and 28
    End point description
    Plasma cortisol concentrations were determined from blood samples collected from the subjects. Analysis was performed on safety population which included all subjects who received at least one dose of the study drug. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline to post dose (1 hr) on Day 1 and 28
    End point values
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler Device
    Number of subjects analysed
    183
    178
    179
    181
    Units: nanomoles per litre (nmol/L)
    arithmetic mean (standard deviation)
        Day 1/1 Hr (n=179, 177,174, 176)
    -32.238 ( 73.4482 )
    -34.491 ( 58.4396 )
    -36.109 ( 67.0512 )
    -34.454 ( 78.3966 )
        Day 28/1 Hr (n= 172, 168, 174, 170)
    -43.135 ( 81.4675 )
    -35.947 ( 83.3223 )
    -38.779 ( 88.2388 )
    -41.097 ( 83.7467 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Mometasone Furoate 80 mcg via the Concept1 Device
    Reporting group description
    		 MF delivered via Concept1, 80 mcg once daily (o.d.) in the evening

    Reporting group title
    Mometasone Furoate 200 mcg via the Twisthaler Device
    Reporting group description
    		 MF delivered via Twisthaler, 200 mcg o.d. in the evening

    Reporting group title
    Mometasone Furoate 320 mcg via the Concept1 Device
    Reporting group description
    		 MF delivered via Concept1, 320 mcg o.d. in the evening

    Reporting group title
    Mometasone Furoate 800 mcg via the Twisthaler device
    Reporting group description
    		 MF delivered via Twisthaler, 800 mcg o.d. in the evening

    Serious adverse events
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler device
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 186 (0.00%)
    0 / 180 (0.00%)
    1 / 183 (0.55%)
    0 / 186 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 186 (0.00%)
    0 / 180 (0.00%)
    1 / 183 (0.55%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 186 (0.00%)
    0 / 180 (0.00%)
    1 / 183 (0.55%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Mometasone Furoate 80 mcg via the Concept1 Device Mometasone Furoate 200 mcg via the Twisthaler Device Mometasone Furoate 320 mcg via the Concept1 Device Mometasone Furoate 800 mcg via the Twisthaler device
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 186 (6.99%)
    17 / 180 (9.44%)
    15 / 183 (8.20%)
    8 / 186 (4.30%)
    Investigations
    Blood cortisol decreased
         subjects affected / exposed
    4 / 186 (2.15%)
    3 / 180 (1.67%)
    5 / 183 (2.73%)
    6 / 186 (3.23%)
         occurrences all number
    4
    3
    5
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 186 (3.23%)
    5 / 180 (2.78%)
    5 / 183 (2.73%)
    0 / 186 (0.00%)
         occurrences all number
    8
    5
    6
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 186 (0.00%)
    4 / 180 (2.22%)
    1 / 183 (0.55%)
    0 / 186 (0.00%)
         occurrences all number
    0
    4
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 186 (1.61%)
    7 / 180 (3.89%)
    6 / 183 (3.28%)
    2 / 186 (1.08%)
         occurrences all number
    3
    7
    6
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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