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Sponsors and Collaborators: |
Schering-Plough Novartis |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00383240 |
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 200 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]).
Condition | Intervention | Phase |
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Asthma |
Drug: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID Drug: Mometasone furoate MDI (MF MDI) Drug: formoterol fumarate 10 mcg 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 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 Medium-Dose Inhaled Glucocorticosteroids |
Estimated Enrollment: | 676 |
Study Start Date: | September 2006 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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MF/F MDI 200/10 mcg BID: Experimental |
Drug: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
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MF MDI 200 mcg BID: Experimental |
Drug: Mometasone furoate MDI (MF MDI)
MF 200 mcg via metered dose inhaler twice daily for 26 weeks
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F MDI 10 mcg BID: Experimental |
Drug: formoterol fumarate 10 mcg
F via metered dose inhaler 10 mcg twice a day for 26 weeks
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Placebo BID: Placebo Comparator |
Drug: Placebo
Placebo metered dose inhaler twice a day for 26 weeks
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
>500-1000 mcg beclomethasone CFC >250-500 mcg beclomethasone HFA budesonide DPI >1000-2000 mcg flunisolide >250-500 mcg fluticasone >400 2000 mcg triamcinolone acetonide >160 to 320 mcg ciclesonide Note: Dose delivery method/modality other than these must be equivalent.
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology ) |
Study ID Numbers: | P04334, Doc ID: 3112650;, EUDRACT No.: 2006-001578-25;, SCH 418131 |
Study First Received: | September 29, 2006 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00383240 |
Health Authority: | United States: Food and Drug Administration |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Mometasone furoate Lung Diseases |
Hypersensitivity, Immediate Formoterol Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Immune System Diseases 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 |