|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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, 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:
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:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P04073, Doc ID: 3100873;, EUDRACT No: 2006-001577-13; |
| Study First Received: | September 29, 2006 |
| Last Updated: | October 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00383552 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 |