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    Clinical Trial Results:
    A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50 mcg BID Delivered by Dry Powder Inhaler (DISKUS®) Versus Mometasone Furoate/Formoterol Fumarate 200/10 mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated with Medium Doses of Inhaled Glucocorticosteroids

    Summary
    EudraCT number
    		 2006-004169-33
    Trial protocol
    		 FI   EE   LT   LV   CZ   DE   SK   NL  
    Global end of trial date
    19 Nov 2008

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

    Trial information

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    Trial identification
    Sponsor protocol code
    P04705
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00424008
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 MK-0887A-116: Merck protocol number
    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
    19 Nov 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Nov 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2008
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate non-inferiority between mometasone furoate/formoterol fumarate (MF/F) metered-dose inhaler (MDI) 200/10 mcg twice daily (BID) and fluticasone propionate/salmeterol (F/SC) dry powder inhaler (DPI) 250/50 mcg BID on the effect of lung function after 12 weeks of treatment, in participants with persistent asthma requiring maintenance treatment on medium doses of inhaled glucocorticosteroids.
    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: subjects were provided with short-acting Beta 2-agonist (SABA, albuterol MDI or salbutamol MDI) rescue medication for the treatment of asthma symptoms and with oral prednisone/prednisolone for acute self-administration at home.
    Background therapy
    		 Participants were provided with short-acting Beta 2-agonist (SABA, albuterol MDI or salbutamol MDI) rescue medication for the treatment of asthma symptoms and with oral prednisone/prednisolone for acute self-administration at home.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Apr 2007
    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
    Canada: 29
    Country: Number of subjects enrolled
    Colombia: 20
    Country: Number of subjects enrolled
    Costa Rica: 60
    Country: Number of subjects enrolled
    Ecuador: 17
    Country: Number of subjects enrolled
    Puerto Rico: 2
    Country: Number of subjects enrolled
    Romania: 14
    Country: Number of subjects enrolled
    Russian Federation: 72
    Country: Number of subjects enrolled
    Netherlands: 9
    Country: Number of subjects enrolled
    Slovakia: 42
    Country: Number of subjects enrolled
    Czech Republic: 108
    Country: Number of subjects enrolled
    Estonia: 13
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Latvia: 18
    Country: Number of subjects enrolled
    Lithuania: 15
    Country: Number of subjects enrolled
    Serbia: 30
    Country: Number of subjects enrolled
    Ukraine: 139
    Country: Number of subjects enrolled
    United States: 117
    Worldwide total number of subjects
    722
    EEA total number of subjects
    236
    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)
    40
    Adults (18-64 years)
    629
    From 65 to 84 years
    53
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants screened were adolescents (≥12 years of age) or adults who had persistent asthma that was previously treated with medium doses of inhaled glucocorticosteroids.

    Period 1
    Period 1 title
    52-Week Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    This was an open-label, evaluator-blind randomized trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MF/F MDI 200/10 mcg BID
    Arm description
    		 Participants received MF/F MDI 200/100 mcg BID for up to 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mometasone Furoate/Formoterol Fumarate
    Investigational medicinal product code
    Other name
    SCH 418131
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    MF/F MDI 200/10 mcg (two inhalations of 100/5 mcg inhaler) BID for up to 52 weeks

    Arm title
    		 F/SC DPI 250/50 mcg BID
    Arm description
    		 Participants received F/SC DPI 250/50 mcg BID for up to 52 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone Propionate/Salmeterol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    F/SC DPI 250/50 mcg BID for up to 52 weeks.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This was an open-label, evaluator-blind randomized trial.
    Number of subjects in period 1
    		MF/F MDI 200/10 mcg BID F/SC DPI 250/50 mcg BID
    Started
    371
    351
    Treated
    365
    349
    Completed
    18
    14
    Not completed
    353
    337
         Did not meet protocol eligibility
    16
    21
         Consent withdrawn by subject
    5
    8
         Administrative
    266
    257
         Adverse event, non-fatal
    8
    6
         Lost to follow-up
    1
    2
         Lack of efficacy
    40
    34
         Protocol deviation
    13
    7
         Not treated
    4
    2

    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 MF/F MDI 200/100 mcg BID for up to 52 weeks.

    Reporting group title
    F/SC DPI 250/50 mcg BID
    Reporting group description
    		 Participants received F/SC DPI 250/50 mcg BID for up to 52 weeks.

    Reporting group values
    		 MF/F MDI 200/10 mcg BID F/SC DPI 250/50 mcg BID Total
    Number of subjects
    		 371 351 722
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 22 18 40
        Adults (18-64 years)
    		 321 308 629
        From 65-84 years
    		 28 25 53
    Gender categorical
    Units: Subjects
        Female
    		 239 220 459
        Male
    		 132 131 263
    Asthma Control Questionnaire (ACQ) Total Score
    The ACQ by Juniper et al. is a mean of 7 equally weighted composite scores; each scaled from 0=best case scenario to 6=worst case scenario on an integer scale. Composites include the following: How Often Woken by Asthma, How Bad Were Asthma Symptoms When You Woke, Activity Limitations, Shortness of Breath, Wheezing, Average Daily Short-Acting Beta 2-Agonist (SABA) Puffs, and physician-evaluated lung function. (n=350, 331)
    Units: score on a scale
        least squares mean (standard deviation)
    		 1.81 ( 0.63 ) 1.78 ( 0.63 ) -
    Percentage of Days and Nights With No Symptoms of Asthma
    For each day of the evaluation period, symptoms were collected in the morning for the night's evaluation, and in the evening for the day's evaluation. Symptoms included coughing, wheezing and difficulty breathing, each integer-scaled from 0=none to 3=severe. A symptom-free day/night is defined as a combined score of 0 across the morning and evening evaluations. (n=364, 349)
    Units: Percentage of symptom-free days/nights
        least squares mean (standard deviation)
    		 0.19 ( 0.28 ) 0.18 ( 0.28 ) -

    End points

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    End points reporting groups
    Reporting group title
    MF/F MDI 200/10 mcg BID
    Reporting group description
    		 Participants received MF/F MDI 200/100 mcg BID for up to 52 weeks.

    Reporting group title
    F/SC DPI 250/50 mcg BID
    Reporting group description
    		 Participants received F/SC DPI 250/50 mcg BID for up to 52 weeks.

    Primary: The Area Under the Curve From 0 to 12 Hours [AUC(0-12 hr)] of the Change From Baseline to Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1)

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    End point title
    		 The Area Under the Curve From 0 to 12 Hours [AUC(0-12 hr)] of the Change From Baseline to Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1)
    End point description
    The mean AUC(0-12 hr) of the change from Baseline to Week 12 in FEV1 was calculated. Baseline was the mean of two pre-dose FEV1 measurements on Day 1. Endpoint was the last post-Baseline non-missing FEV1 AUC(0-12 hr) result carried forward. Least squares (LS) means and pooled standard deviations were obtained from the analysis of covariance (ANCOVA) model with treatment, site effects and the Baseline FEV1 (Liters) as a covariate.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 MF/F MDI 200/10 mcg BID F/SC DPI 250/50 mcg BID
    Number of subjects analysed
    366 [1]
    346 [2]
    Units: L x hr
        least squares mean (standard deviation)
    3.43 ( 3.83 )
    3.24 ( 3.83 )
    Notes
    [1] - Randomized participants who received ≥1 dose study drug and had Baseline and any post-Baseline data.
    [2] - Randomized participants who received ≥1 dose study drug and had Baseline and any post-Baseline data.
    Statistical analysis title
    		 Change from Baseline ANCOVA - Baseline FEV1
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.007
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Change from Baseline ANCOVA - Treatment
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.54
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Change from Baseline ANCOVA - Site
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.008
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Onset-of-action Based on Change from Baseline FEV1 at the 5 Minute Pulmonary Function Test (PFT) Assessment on Day 1

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    End point title
    		 Onset-of-action Based on Change from Baseline FEV1 at the 5 Minute Pulmonary Function Test (PFT) Assessment on Day 1
    End point description
    PFTs, including FEV1, were done on Day 1. Evaluations included 30 min before and immediately before the first dose of study drug, the mean of which was Baseline, and at intervals from 5 min to 12 hr postdose. Onset of action was defined as statistically significant improvement of MF/F over F/SC in Change from Baseline FEV1 at the 5-min postdose evaluation on Day 1. The same series of PFTs was done at Week 12. Change from Baseline to Week 12 evalutions were calculated using the same Day 1 predose scores for Baseline. Post-Baseline LS means and pooled standard deviations were obtained from the ANCOVA model with treatment, site effects and Baseline FEV1 (Liters) as a covariate. Baseline LS means exclude the covariate.
    End point type
    Secondary
    End point timeframe
    Baseline and 5 minutes postdose on Day 1
    End point values
    		 MF/F MDI 200/10 mcg BID F/SC DPI 250/50 mcg BID
    Number of subjects analysed
    365 [3]
    348 [4]
    Units: Liters
        least squares mean (standard deviation)
    0.2 ( 0.2 )
    0.09 ( 0.2 )
    Notes
    [3] - Randomized participants who received ≥1 dose study drug and had Baseline and any post-Baseline data.
    [4] - Randomized participants who received ≥1 dose study drug and had Baseline and any post-Baseline data.
    Statistical analysis title
    		 Change from Baseline ANCOVA - Baseline FEV1
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    713
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.033
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Change from Baseline ANCOVA - Treatment
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    713
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Change from Baseline ANCOVA - Site
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    713
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint

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    End point title
    		 Change from Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint
    End point description
    The ACQ by Juniper et al. is a mean of 7 equally weighted composite scores; each scaled from 0=best case scenario to 6=worst case scenario on an integer scale. Composites include the following: How Often Woken by Asthma, How Bad Were Asthma Symptoms When You Woke, Activity Limitations, Shortness of Breath, Wheezing, Average Daily Short-Acting Beta 2-Agonist (SABA) Puffs, and physician-evaluated lung function. With the exception of physician-evaluated lung function collected at the visit, evaluations were over the last week recall period. Endpoint was the last post-Baseline non-missing ACQ result carried forward. Post-Baseline LS means and pooled standard deviations were obtained from the ANCOVA model with treatment, site effects and the Baseline ACQ score as a covariate. Baseline LS means exclude the covariate.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 MF/F MDI 200/10 mcg BID F/SC DPI 250/50 mcg BID
    Number of subjects analysed
    350 [5]
    331 [6]
    Units: Score on a scale
        least squares mean (standard deviation)
    -0.65 ( 0.61 )
    -0.65 ( 0.61 )
    Notes
    [5] - Randomized participants who received ≥1 dose study drug and had Baseline and any post-Baseline data.
    [6] - Randomized participants who received ≥1 dose study drug and had Baseline and any post-Baseline data.
    Statistical analysis title
    		 Change from Baseline ANCOVA - Baseline ACQ Score
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    681
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Change from Baseline ANCOVA - Treatment
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    681
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.925
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Change from Baseline ANCOVA - Site
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    681
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from Baseline in the Percentage of Days and Nights With No Symptoms of Asthma

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    End point title
    		 Change from Baseline in the Percentage of Days and Nights With No Symptoms of Asthma
    End point description
    For each day of the evaluation period, symptoms were collected in the morning for the night's evaluation, and in the evening for the day's evaluation. Symptoms included coughing, wheezing and difficulty breathing, each integer-scaled from 0=none to 3=severe. A symptom-free day/night is defined as a combined score of 0 across the morning and evening evaluations. The percentage of 0 scores across the Baseline period and across the 12-week treatment period were calculated to determine the overall percentage of symptom-free days/nights for each of these periods. Post-Baseline LS means and pooled standard deviations were obtained from the ANCOVA model with treatment, site effects and the Baseline as a covariate. Baseline LS means exclude the covariate.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 MF/F MDI 200/10 mcg BID F/SC DPI 250/50 mcg BID
    Number of subjects analysed
    364 [7]
    349 [8]
    Units: Percentage of symptom-free days/nights
        least squares mean (standard deviation)
    0.24 ( 0.32 )
    0.25 ( 0.32 )
    Notes
    [7] - Randomized participants who received ≥1 dose study drug and had Baseline and any post-Baseline data.
    [8] - Randomized participants who received ≥1 dose study drug and had Baseline and any post-Baseline data.
    Statistical analysis title
    		 Change from Baseline ANCOVA - Baseline Value
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    713
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Change from Baseline ANCOVA - Treatment
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    713
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.628
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Change from Baseline ANCOVA - Site
    Statistical analysis description
    MF/F MDI 200/10 mcg BID vs. F/SC DPI 250/50 mcg BID pairwise comparison p-value
    Comparison groups
    MF/F MDI 200/10 mcg BID v F/SC DPI 250/50 mcg BID
    Number of subjects included in analysis
    713
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 52 weeks
    Adverse event reporting additional description
    The safety population consists of all participants who received ≥1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    MF/F MDI 200/10 mcg BID
    Reporting group description
    		 Participants received MF/F MDI 200/100 mcg BID for up to 52 weeks.

    Reporting group title
    F/SC DPI 250/50 mcg BID
    Reporting group description
    		 Participants received F/SC DPI 250/50 mcg BID for up to 52 weeks.

    Serious adverse events
    		 MF/F MDI 200/10 mcg BID F/SC DPI 250/50 mcg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 371 (1.62%)
    8 / 351 (2.28%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Skin Injury
         subjects affected / exposed
    0 / 371 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Unstable
         subjects affected / exposed
    0 / 371 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Extrasystoles
         subjects affected / exposed
    1 / 371 (0.27%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 371 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 371 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    1 / 371 (0.27%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis Acute
         subjects affected / exposed
    1 / 371 (0.27%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 371 (0.27%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 371 (0.27%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    0 / 371 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    0 / 371 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 371 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    1 / 371 (0.27%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 371 (0.27%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 371 (0.27%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 371 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 371 (0.00%)
    1 / 351 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 371 (0.27%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 371 (0.27%)
    0 / 351 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MF/F MDI 200/10 mcg BID F/SC DPI 250/50 mcg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 371 (22.91%)
    77 / 351 (21.94%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    42 / 371 (11.32%)
    45 / 351 (12.82%)
         occurrences all number
    109
    88
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    33 / 371 (8.89%)
    24 / 351 (6.84%)
         occurrences all number
    38
    27
    Upper Respiratory Tract Infection
         subjects affected / exposed
    25 / 371 (6.74%)
    16 / 351 (4.56%)
         occurrences all number
    31
    20

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Mar 2008
    Amendment 01: Added a Screening Period separate from the Open-label Run-in Period. The open-label run-in medication was to have been dispensed at Visit 1; however, it was now clearly stated that participants would NOT start taking open-label MF MDI (run-in medication) until after the laboratory results were available and found to be clinically acceptable. The participants were contacted by telephone and told to stop taking their own standard ICS or fixed dose combination (FDC) treatment the following morning, and start taking their run-in study medication at that time. Participants with unacceptable laboratory results were not to be allowed to continue in the study and were required to have a termination visit. Additional clarifications were added to Selection Criteria. To reflect various Ethics Committees and Competent Authorities requirements, the age of participants in the study was also modified for the Czech Republic, Finland, Estonia, Germany, Lithuania, Russia, and Ukraine. The study discontinuation criteria were also further clarified to make evident that participants requiring the use of systemic corticosteroids, including oral prednisone/prednisolone during the study would be discontinued.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    14 Nov 2008
    The sponsor closed the study early, at 12 weeks treatment, for reasons that were not safety related. No efficacy analysis of data collected beyond 12 weeks of treatment was performed. All safety data were examined regardless of treatment duration.
    -

    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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