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| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 29, 2006 |
| Last Updated Date | October 16, 2009 |
| Start Date ICMJE | September 2006 |
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
AUC(0-12 hr) of change from Baseline FEV1 for MF/F vs MF. Average of the 2 predose FEV1 measurements at Baseline will be subtracted from each of the serial measurements over the 12-hr. period. [ Time Frame: AUC(0-12 hr) of change from Baseline to Week 12 FEV1 and Time to first asthma exacerbation over 26 weeks of treatment. ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00383552 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
For MF/F vs placebo: Change from Baseline in AQLQ(S) and ACQ total score and proportion of nights across the Treatment Period with nocturnal awakenings due to asthma which require use of SABA. [ Time Frame: Baseline to Week 26 ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED) |
| Official Title ICMJE | A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate/Formoterol Fumarate Combination Formulation Compared With Mometasone Furoate and Formoterol Monotherapy in Subjects With Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids |
| Brief Summary | This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 100 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by mean change from Baseline to Week 12 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12 hr]). |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Condition ICMJE | Asthma |
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 676 |
| Completion Date | August 2008 |
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
200-500 mcg beclomethasone CFC 100-250 mcg beclomethasone HFA 200-600 mcg budesonide DPI 500-1000 mcg flunisolide 100-250 mcg fluticasone 200 mcg MF 400-1000 mcg triamcinolone acetonide 80 to 160 mcg ciclesonide Note: Dose delivery by method/modality other than these must be equivalent.
Demonstrate increase in absolute FEV1 >=12% & >=200 mL within approximately 15 to 20 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose 360-400 mcg) or nebulized SABA (2.5 mg) if confirmed as standard office practice, OR Demonstrate PEF variability >20% expressed as percentage of the mean highest & lowest morning prebronchodilator (before taking albuterol/salbutamol) PEF over >=1 week, OR Demonstrate diurnal variation in PEF of >20% based on difference between prebronchodilator (before taking albuterol/salbutamol) morning value & postbronchodilator value (after taking albuterol/salbutamol) from evening before, expressed as percentage of mean daily PEF value.
Exclusion Criteria:
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| Gender | Both |
| Ages | 12 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00383552 |
| Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| Study ID Numbers ICMJE | P04073, Doc ID: 3100873;, EUDRACT No: 2006-001577-13; |
| Study Sponsor ICMJE | Schering-Plough |
| Collaborators ICMJE | Novartis |
| Investigators ICMJE | |
| Information Provided By | Schering-Plough |
| Verification Date | October 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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