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Sponsors and Collaborators: |
Schering-Plough Novartis |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00383721 |
This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). This is a 26 week Efficacy and Safety study with a 26 week safety extension. Efficacy is not measured for 52 weeks. Efficacy will be measured by the mean change from Baseline to Week 26 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12hr]). Efficacy will also be measured by time-to-first COPD exacerbation over the 52-week Treatment Period for the comparison of MF/F versus F. Secondary efficacy variable will be COPD control scores from diary.
Condition | Intervention | Phase |
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Chronic Obstructive Pulmonary Disease (COPD) |
Drug: Mometasone furoate/formoterol (MF/F) combination Drug: Mometasone furoate MDI (MF MDI) Drug: Formoterol MDI Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, 26-Week, Placebo-Controlled Efficacy and Safety Study With a 26-Week Long-Term Safety Extension, of High- and Medium-Dose Inhaled Mometasone Furoate/Formoterol Fixed-Dose Combination Formulation Compared With Formoterol and High-Dose Inhaled Mometasone Furoate Monotherapy in Subjects With Moderate to Severe COPD |
Estimated Enrollment: | 1000 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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MF/F MDI 400/10 mcg BID: Experimental |
Drug: Mometasone furoate/formoterol (MF/F) combination
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
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MF/F MDI 200/10 mcg BID: Experimental |
Drug: Mometasone furoate/formoterol (MF/F) combination
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
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MF MDI 400 mcg BID: Experimental |
Drug: Mometasone furoate MDI (MF MDI)
MF 400 mcg via metered dose inhaler twice daily for 52 weeks
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Formoterol MDI 10 mcg BID: Active Comparator |
Drug: Formoterol MDI
Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks
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Placebo MDI BID: Placebo Comparator |
Drug: Placebo
Placebo MDI twice a day for 26 weeks
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Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A history and/or presence of intraocular pressure in either eye >=22 mm Hg, glaucoma, and/or posterior subcapsular cataracts. A subject who has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. A subject with a history of penetrating trauma to both eyes. A subject with one or more of the following LOCS III grades at screening:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Study Director: | Jonathan Sadeh, MD | Schering-Plough |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04230, Doc ID: 3227335,, Eudract No: 2006-002309-30, |
Study First Received: | September 29, 2006 |
Last Updated: | December 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00383721 |
Health Authority: | United States: Food and Drug Administration |
Lung Diseases, Obstructive Respiratory Tract Diseases Mometasone furoate Lung Diseases |
Respiration Disorders Formoterol Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents |
Anti-Allergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |