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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 MDI formulation and medium dose mometasone furoate 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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 90 |
| 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 |
|---|---|
| MF/F Arm 1: Experimental |
Drug: mometasone furoate/formoterol 100/10 mcg
mometasone furoate/formoterol 100/10 mcg BID (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days
|
| MF/F Arm 2: Experimental |
Drug: mometasone furoate/formoterol 200/10 mcg
mometasone furoate/formoterol 200/10 mcg BID (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days
|
| MF/F Arm 3: Experimental |
Drug: mometasone furoate/formoterol 400/10 mcg
mometasone furoate/formoterol 400/10 mcg BID (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days
|
| MF Arm 1: Experimental |
Drug: MF DPI 200 mcg
MF DPI 200 mcg BID (one inhalation of MF DPI 200 mcg) for 14 days
|
| MF Arm 2: Experimental |
Drug: MF MDI 200 mcg
MF MDI 200 mcg BID (two inhalations of MF MDI 100 mcg) for 14 days
|
| Placebo: Experimental |
Drug: Placebo
MF/F MDI placebo 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 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 SPRI computer-generated randomization schedule. Randomization will be performed in appropriately sized blocks using random numbers generated by 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 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: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P05122 |
| Study First Received: | January 21, 2008 |
| Last Updated: | September 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00635882 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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mometasone formoterol |
|
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 Pathologic Processes Respiratory Tract Diseases Therapeutic Uses Formoterol |
Immune System Diseases Adrenergic beta-Agonists Mometasone furoate Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Inflammation Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |