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    Clinical Trial Results:
    A 12-Week Efficacy and Safety Study of Two Doses of Mometasone Furoate/Formoterol Combination Formulation Compared With Mometasone Furoate Monotherapy, in Persistent Asthmatics Previously treated With High-Dose Inhaled Glucocorticosteroids

    Summary
    EudraCT number
    		 2005-005910-20
    Trial protocol
    		 HU   DK  
    Global end of trial date
    30 Jan 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2016
    First version publication date
    09 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P04431
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00381485
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Number: MK-0887A-099
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000025-PIP01-07
    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
    30 Jan 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jan 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, participants will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during the open-label (OL) run-in period. Efficacy will be measured by the area under the time curve from 0 to 12 hours (AUC [0-12 hr]) of the change from Baseline (BL) to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. The following additional measures defined for this individual study were in place for the protection of trial subjects: All participants in the current study were carefully monitored for asthma exacerbations and were provided with an asthma action plan with immediate availability of emergency rescue oral steroids (e.g. prednisone) and short-acting beta 2-agonists (SABA), and had access to around-the-clock physician contact. Participants were provided with a SABA Metered Dose Inhaler (MDI) at the Screening Visit for use as rescue medication during the study, and were advised not to take the SABA via an MDI or a nebulizer regularly or in anticipation of asthma symptoms. Rescue medication was recorded in the Patient Diary.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jul 2006
    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
    Denmark: 2
    Country: Number of subjects enrolled
    Hungary: 107
    Country: Number of subjects enrolled
    Argentina: 28
    Country: Number of subjects enrolled
    Bulgaria: 79
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Chile: 23
    Country: Number of subjects enrolled
    Colombia: 24
    Country: Number of subjects enrolled
    Guatemala: 31
    Country: Number of subjects enrolled
    Peru: 24
    Country: Number of subjects enrolled
    Poland: 129
    Country: Number of subjects enrolled
    Russian Federation: 158
    Country: Number of subjects enrolled
    Ukraine: 132
    Country: Number of subjects enrolled
    United States: 93
    Worldwide total number of subjects
    834
    EEA total number of subjects
    317
    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)
    66
    Adults (18-64 years)
    664
    From 65 to 84 years
    104
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 834 participants enrolled in the open-label Run-In Period, of which 728 participants were randomized into 1 of 3 arms. Of 728 randomized participants, 643 participants overall completed the Treatment Period, while 85 participants overall discontinued investigational treatment early. All randomized participants received ≥1 dose of study medication.

    Period 1
    Period 1 title
    Open-Label Run-In Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 OL MF MDI 400 MCG BID
    Arm description
    		 Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
    Arm type
    		 Run-In

    Investigational medicinal product name
    Mometasone furoate MDI (MF MDI)
    Investigational medicinal product code
    Other name
    SCH 032088
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Open-label MF 400 mcg via metered dose inhaler twice daily for approximately 2 to 3 weeks.

    Number of subjects in period 1
    		OL MF MDI 400 MCG BID
    Started
    834
    Completed
    728
    Not completed
    106
         Did not meet protocol eligibility
    76
         Adverse event, non-fatal
    9
         Treatment Failure
    1
         Subject did not wish to continue-reasons related
    16
         Subject did not wish to continue-reasons unrelated
    1
         Lost to follow-up
    3
    Period 2
    Period 2 title
    Double-Blind Treatment Period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MF/F MDI 200/10 mcg BID
    Arm description
    		 Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone furoate 200 mcg/formoterol 10 mcg (MF/F) combination
    Investigational medicinal product code
    Other name
    SCH 418131
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks

    Arm title
    		 MF/F MDI 400/10 mcg BID
    Arm description
    		 Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone furoate 400 mcg/formoterol 10 mcg (MF/F) combination
    Investigational medicinal product code
    Other name
    SCH 418131
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks

    Arm title
    		 MF MDI 400 mcg BID
    Arm description
    		 Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone furoate MDI (MF MDI)
    Investigational medicinal product code
    Other name
    SCH 032088
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    MF 400 mcg via metered dose inhaler twice daily for 12 weeks

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 represents an open-label run-in to standardize treatment—not all of these subjects participated in the trial. Period 2 (baseline period) represents the randomized double-blind treatment phase. This is the primary study period of interest, thus baseline characteristics are reported for this period.
    Number of subjects in period 2 [2]
    		MF/F MDI 200/10 mcg BID MF/F MDI 400/10 mcg BID MF MDI 400 mcg BID
    Started
    233
    255
    240
    Completed
    208
    228
    207
    Not completed
    25
    27
    33
         Did not meet protocol eligibility
    7
    5
    5
         Consent withdrawn by subject
    1
    2
    5
         Adverse event, non-fatal
    2
    2
    5
         'Noncompliance with protocol '
    3
    9
    3
         Lost to follow-up
    1
    -
    1
         'Administrative '
    -
    1
    1
         Lack of efficacy
    11
    8
    13
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects in the baseline period represent those who were randomized to treatment on study—this is the primary population of interest. The worldwide number represents all enrolled subjects who entered an open-label run-in to standardize treatment—not all of these subjects participated in the trial.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MF/F MDI 200/10 mcg BID
    Reporting group description
    		 Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.

    Reporting group title
    MF/F MDI 400/10 mcg BID
    Reporting group description
    		 Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.

    Reporting group title
    MF MDI 400 mcg BID
    Reporting group description
    		 Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.

    Reporting group values
    		 MF/F MDI 200/10 mcg BID MF/F MDI 400/10 mcg BID MF MDI 400 mcg BID Total
    Number of subjects
    		 233 255 240 728
    Age categorical
    Units: Subjects
        <18 years
    		 18 23 22 63
        18 to <65 years
    		 189 200 189 578
        ≥65 years
    		 26 32 29 87
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.4 ( 16.3 ) 47.7 ( 15.6 ) 47.8 ( 16.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 135 138 136 409
        Male
    		 98 117 104 319

    End points

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    End points reporting groups
    Reporting group title
    OL MF MDI 400 MCG BID
    Reporting group description
    		 Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
    Reporting group title
    MF/F MDI 200/10 mcg BID
    Reporting group description
    		 Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.

    Reporting group title
    MF/F MDI 400/10 mcg BID
    Reporting group description
    		 Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.

    Reporting group title
    MF MDI 400 mcg BID
    Reporting group description
    		 Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.

    Primary: LS Mean AUC [0-12 Hours] of the Change From Baseline to Week 12 in FEV1

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    End point title
    		 LS Mean AUC [0-12 Hours] of the Change From Baseline to Week 12 in FEV1
    End point description
    Spirometry was performed to measure FEV1. The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F versus MF. Standard deviation was pooled.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 MF/F MDI 200/10 mcg BID MF/F MDI 400/10 mcg BID MF MDI 400 mcg BID
    Number of subjects analysed
    204 [1]
    231 [2]
    211 [3]
    Units: Liter x hour
        least squares mean (standard deviation)
    3.59 ( 3.63 )
    4.19 ( 3.63 )
    2.04 ( 3.63 )
    Notes
    [1] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    [2] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    [3] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    Statistical analysis title
    		 FEV1(AUC): MF/F MDI 200/10 mcg vs. MF MDI 400 mcg
    Statistical analysis description
    Least Squares (LS) Means and pooled standard deviations (Pstd) for post-baseline evaluations were obtained from the ANCOVA model with treatment, site effects, and the baseline FEV1 (liters) as a covariate. BL was the mean of two pre-dose measurements (30 minutes before dosing and 0 hour, immediately before dosing) on Day 1. The last post-BL non-missing FEV1 AUC(0-12 hr) result carried forward was used.
    Comparison groups
    MF/F MDI 200/10 mcg BID v MF MDI 400 mcg BID
    Number of subjects included in analysis
    415
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 FEV1(AUC): MF/F MDI 400/10 mcg vs. MF MDI 400 mcg
    Statistical analysis description
    Least Squares (LS) Means and Pstd for post-baseline evaluations were obtained from the ANCOVA model with treatment, site effects, and the baseline FEV1 (liters) as a covariate. BL was the mean of two pre-dose measurements (30 minutes before dosing and 0 hour, immediately before dosing) on Day 1. The last post-BL non-missing FEV1 AUC(0-12 hr) result carried forward was used.
    Comparison groups
    MF/F MDI 400/10 mcg BID v MF MDI 400 mcg BID
    Number of subjects included in analysis
    442
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change From Baseline to Week 12 in Asthma Control Questionnaire (ACQ) Total Score

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    End point title
    		 Change From Baseline to Week 12 in Asthma Control Questionnaire (ACQ) Total Score
    End point description
    The ACQ is a simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The ACQ Total score was the mean of the individual seven questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 MF/F MDI 200/10 mcg BID MF/F MDI 400/10 mcg BID MF MDI 400 mcg BID
    Number of subjects analysed
    205 [4]
    222 [5]
    206 [6]
    Units: Units on a Scale
        least squares mean (standard deviation)
    -0.59 ( 0.63 )
    -0.58 ( 0.63 )
    -0.42 ( 0.63 )
    Notes
    [4] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    [5] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    [6] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 12 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score

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    End point title
    		 Change From Baseline to Week 12 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score
    End point description
    The AQLQ(S) for patients 12 years and older is a modified version of the AQLQ(S) that was originally designed to measure functional impairments that were most important for adults only; it was slightly changed to include questions about school activities. The AQLQ(S) measures the following four domains: symptoms, emotional functioning, impact of environmental stimuli, and activity limitation. AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The AQLQ(S) Total score was the mean of the individual 32 questions. The comparison was for MF/F versus placebo. Standard deviation was pooled.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 MF/F MDI 200/10 mcg BID MF/F MDI 400/10 mcg BID MF MDI 400 mcg BID
    Number of subjects analysed
    205 [7]
    223 [8]
    208 [9]
    Units: Units on a Scale
        least squares mean (standard deviation)
    0.61 ( 0.7 )
    0.51 ( 0.7 )
    0.5 ( 0.7 )
    Notes
    [7] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    [8] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    [9] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    No statistical analyses for this end point

    Secondary: Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma That Require Use of Short-Acting Beta Agonists (SABA)

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    End point title
    		 Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma That Require Use of Short-Acting Beta Agonists (SABA)
    End point description
    Baseline was the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0 = no awakenings to 1 = awakenings every night. The comparison was for MF/F versus placebo. Standard deviation was pooled.
    End point type
    Secondary
    End point timeframe
    12-week Treatment Period
    End point values
    		 MF/F MDI 200/10 mcg BID MF/F MDI 400/10 mcg BID MF MDI 400 mcg BID
    Number of subjects analysed
    233 [10]
    255 [11]
    239 [12]
    Units: Proportion of nights
        least squares mean (standard deviation)
    -0.1 ( 0.17 )
    -0.1 ( 0.17 )
    -0.05 ( 0.17 )
    Notes
    [10] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    [11] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    [12] - All Randomized Participants with BL and any post-BL data (intent-to-treat principle).
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Open-Label Run-In + DB Treatment Period (Day -21 to Week 12)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    OL MF MDI 400 MCG BID
    Reporting group description
    		 Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.

    Reporting group title
    MF MDI 400 MCG BID
    Reporting group description
    		 Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.

    Reporting group title
    MF/F MDI 400/10 MCG BID
    Reporting group description
    		 Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.

    Reporting group title
    MF/F MDI 200/10 MCG BID
    Reporting group description
    		 Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.

    Serious adverse events
    		 OL MF MDI 400 MCG BID MF MDI 400 MCG BID MF/F MDI 400/10 MCG BID MF/F MDI 200/10 MCG BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 834 (0.24%)
    3 / 240 (1.25%)
    2 / 255 (0.78%)
    3 / 233 (1.29%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Alanine Aminotransferase* Increased
         subjects affected / exposed
    1 / 834 (0.12%)
    0 / 240 (0.00%)
    0 / 255 (0.00%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate Aminotransferase* Increased
         subjects affected / exposed
    1 / 834 (0.12%)
    0 / 240 (0.00%)
    0 / 255 (0.00%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Drug Exposure During Pregnancy
         subjects affected / exposed
    0 / 834 (0.00%)
    0 / 240 (0.00%)
    0 / 255 (0.00%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 834 (0.00%)
    0 / 240 (0.00%)
    0 / 255 (0.00%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 834 (0.00%)
    1 / 240 (0.42%)
    0 / 255 (0.00%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 834 (0.00%)
    0 / 240 (0.00%)
    0 / 255 (0.00%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis Ulcerative
         subjects affected / exposed
    0 / 834 (0.00%)
    1 / 240 (0.42%)
    0 / 255 (0.00%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colonic Polyp
         subjects affected / exposed
    0 / 834 (0.00%)
    1 / 240 (0.42%)
    0 / 255 (0.00%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 834 (0.12%)
    0 / 240 (0.00%)
    0 / 255 (0.00%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 834 (0.00%)
    0 / 240 (0.00%)
    1 / 255 (0.39%)
    0 / 233 (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
    Haemoptysis
         subjects affected / exposed
    0 / 834 (0.00%)
    1 / 240 (0.42%)
    0 / 255 (0.00%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide Attempt
         subjects affected / exposed
    0 / 834 (0.00%)
    0 / 240 (0.00%)
    0 / 255 (0.00%)
    1 / 233 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Artery Stenosis
         subjects affected / exposed
    0 / 834 (0.00%)
    0 / 240 (0.00%)
    1 / 255 (0.39%)
    0 / 233 (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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 834 (0.12%)
    0 / 240 (0.00%)
    0 / 255 (0.00%)
    0 / 233 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 OL MF MDI 400 MCG BID MF MDI 400 MCG BID MF/F MDI 400/10 MCG BID MF/F MDI 200/10 MCG BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 834 (0.72%)
    13 / 240 (5.42%)
    12 / 255 (4.71%)
    8 / 233 (3.43%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 834 (0.72%)
    13 / 240 (5.42%)
    12 / 255 (4.71%)
    8 / 233 (3.43%)
         occurrences all number
    6
    14
    13
    8

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Nov 2006
    P04431 Amendment 1 added an additional treatment arm (MF/F 200/10 mcg BID) to the study, which increased study enrollment from 414 to 621. Amendment 1 also changed the primary analysis endpoint from Week 1 to Week 12 (which changed the primary objective) and revised the secondary objectives to include assessment of asthma control by ACQ, AQLQ(S), and proportion of nocturnal awakenings due to asthma which require use of SABA. Revision to the Statistical Analysis Plan was also required to address these changes.
    27 Dec 2007
    Amendment 2 added a Screening Period separate from the open-label Run-in Period and added telephone contact between Visit 1 and Visit 2, and clarified that participants would NOT start taking open-label run-in medication until after the laboratory results were available and found to be clinically acceptable. Amendment 2 also clarified several eligibility criteria (including modifying the age limit for countries such as Russia where minors are not permitted in clinical studies) and discontinuation criteria. Finally, Amendment 2 revised the defined stability limit in the definition of asthma exacerbation (secondary efficacy endpoint).

    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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