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| Sponsors and Collaborators: |
Schering-Plough 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, 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]).
| 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: | 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 Low-Dose Inhaled Glucocorticosteroids |
| Estimated Enrollment: | 676 |
| 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 |
|---|---|
| MF/F MDI 100/10 mcg BID: Experimental |
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
|
| MF MDI 100 mcg BID: Experimental |
Drug: Mometasone furoate MDI (MF MDI)
MF 100 mcg via metered dose inhaler twice daily for 26 weeks
|
| F MDI 10 mcg BID: Experimental |
Drug: formoterol fumarate 10 mcg
F via metered dose inhaler 10 mcg twice a day for 26 weeks
|
| Placebo BID: Placebo Comparator |
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:
>=12 years, either sex, any race, asthma diagnosis >=12 months that is consistent with the following: Diagnosis based on clinical history
Exclusion Criteria:
Examples include (but are not limited to) insulin-dependent diabetes, hypertension being treated with beta-blockers, active hepatitis, coronary artery disease, arrhythmia, significant QTc prolongation (ie QTcF or QTcB [Fridericia or Bazett corrections, respectively >500 msecs), stroke, severe rheumatoid arthritis, chronic open-angle glaucoma or posterior subcapsular cataracts (including prior cataract surgery), AIDS, or conditions that may interfere with respiratory function such as COPD, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis. Others which are well-controlled
stable (eg hypertension not requiring beta-blockers) will not prohibit participation if deemed appropriate by investigator.
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology ) |
| Study ID Numbers: | P04073, Doc ID: 3100873;, EUDRACT No: 2006-001577-13; |
| Study First Received: | September 29, 2006 |
| Last Updated: | October 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00383552 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Inflammatory Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Adrenergic beta-Agonists Mometasone furoate Anti-Asthmatic Agents Asthma Anti-Allergic Agents Adrenergic Agonists |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Formoterol Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
|
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Formoterol |
Adrenergic beta-Agonists Immune System Diseases Mometasone furoate Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |