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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00635882 |
Purpose
This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate (MF) dry powder inhaler (DPI) and MDI formulations in adults and adolescents with persistent allergic asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma Airway Inflammation |
Drug: mometasone furoate/formoterol 100/10 mcg Drug: mometasone furoate/formoterol 200/10 mcg Drug: mometasone furoate/formoterol 400/10 mcg Drug: MF DPI 200 mcg Drug: MF MDI 200 mcg Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A 2-Week Double-Blind, Placebo-Controlled, Parallel Group Study Comparing the Anti-Inflammatory Effects of Low, Medium, and High Dose Mometasone Furoate/Formoterol Fumarate MDI Formulation and Medium Dose Mometasone Furoate DPI and MDI Formulations in Adults and Adolescents With Persistent Allergic Asthma |
| Enrollment: | 93 |
| Study Start Date: | February 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: MF/F MDI 100/10 mcg |
Drug: mometasone furoate/formoterol 100/10 mcg
mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days
Other Name: MF/F (SCH 418131)
|
| Experimental: MF/F MDI 200/10 mcg |
Drug: mometasone furoate/formoterol 200/10 mcg
mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days
Other Name: MF/F 200/10 (SCH 418131)
|
| Experimental: MF/F MDI 400/10 mcg |
Drug: mometasone furoate/formoterol 400/10 mcg
mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days
Other Name: MF/F 400/10 (SCH 418131)
|
| Experimental: MF DPI 200 mcg |
Drug: MF DPI 200 mcg
MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days
Other Name: mometasone furoate (SCH 32088)
|
| Experimental: MF MDI 200 mcg |
Drug: MF MDI 200 mcg
MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days
Other Name: mometasone furoate (SCH 32088)
|
| Experimental: Placebo |
Drug: Placebo
MF/F MDI placebo twice daily (BID) (2 inhalations)
|
This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate MDI formulation and medium dose mometasone furoate (MF) DPI and MDI formulations in adults and adolescents with persistent allergic asthma. An open-label run in period is to be followed by a double-blind treatment period.
A total of 90 subjects (15 per treatment) will be enrolled to ensure 12 subjects per treatment at the Day 14 evaluation, accounting for a 20% drop-out rate. A sample size of 12 subjects per treatment is required to detect a treatment difference of 28% in percent change of eNO at Day 14, assuming a pooled standard deviation of 20% with a power of 90%. These estimates are based on examination of eNO levels in asthmatic vs healthy subjects in an article written by S.A. Kharitonov et. al, 2003.
Subjects will be randomized to one of six treatment groups (MF/F MDI 100/10 mcg BID, MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, MF DPI 200 mcg BID, MF MDI 200 mcg BID, or Placebo MDI BID) according to an Schering-Plough Research Institute (SPRI) computer-generated randomization schedule. Randomization will be performed in appropriately sized blocks using random numbers generated by statistical analysis software (SAS).
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To document asthma diagnosis, historical reversibility defined as an increase in absolute forced expiratory volume (in liters) in 1 second (FEV1) of >= 12% and >= 200 mL must have been performed within 12 months of Screening. For subjects without historical reversibility, one of the following methods can be used at the Screening Visit or at any time before the Baseline Visit:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00635882 History of Changes |
| Other Study ID Numbers: | P05122 |
| Study First Received: | January 21, 2008 |
| Results First Received: | October 22, 2010 |
| Last Updated: | February 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
mometasone formoterol |
|
Asthma Inflammation Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pathologic Processes Mometasone furoate Anti-Inflammatory Agents Formoterol Therapeutic Uses |
Pharmacologic Actions Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Anti-Allergic Agents |