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| Sponsor: | Schering-Plough |
|---|---|
| Collaborator: |
Novartis |
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00383552 |
Purpose
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, participants will receive open-label (OL) MF MDI 100 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by the Area Under the Curve from 0 to 12 hours [AUC](0-12 hours) of the change from Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) and by the time-to-first severe asthma exacerbation across the 26-week treatment period.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID Drug: Mometasone Furoate MDI (MF MDI) Drug: Formoterol Fumarate 10 mcg Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 746 |
| Study Start Date: | September 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: MF/F MDI 100/10 mcg BID |
Drug: Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID
MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
Other Name: SCH 418131
|
| Experimental: MF MDI 100 mcg BID |
Drug: Mometasone Furoate MDI (MF MDI)
MF 100 mcg via metered dose inhaler twice daily for 26 weeks
Other Name: SCH 32088
|
| Experimental: F MDI 10 mcg BID |
Drug: Formoterol Fumarate 10 mcg
F via metered dose inhaler 10 mcg twice a day for 26 weeks
Other Name: Foradil
|
| Placebo Comparator: Placebo BID |
Drug: Placebo
Placebo metered dose inhaler twice a day for 26 weeks
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
200-500 mcg beclomethasone chlorofluorocarbon (CFC), 100-250 mcg beclomethasone hydrofluoroalkane (HFA), 200-600 mcg budesonide dry powder inhaler (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 short-acting beta agonist (SABA) (2.5 mg) if confirmed as standard office practice, OR Demonstrate peak expiratory flow (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:
Contacts and Locations
More Information
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00383552 History of Changes |
| Other Study ID Numbers: | P04073, Doc ID: 3100873;, EUDRACT No: 2006-001577-13; |
| Study First Received: | September 29, 2006 |
| Results First Received: | July 15, 2010 |
| Last Updated: | September 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Formoterol Mometasone furoate Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Anti-Allergic Agents Anti-Inflammatory Agents |