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| Sponsored by: |
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 |
| Estimated Study Completion Date: | June 2009 |
| Estimated 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:
Visit or at any time before the Baseline Visit:
Demonstration of a diurnal variation PEF of more than 20% based on the difference between the prebronchodilator (before taking albuterol/salbutamol) morning value and the postbronchodilator value (after taking albuterol/salbutamol) from the evening before, expressed as a percentage of the mean daily PEF value on any day during the open-label Run-in Period. {The calculation formula: Diurnal PEF Variation = Absolute [(highest of 3 readings, PM Post-BD PEF from prior evening) - (highest of 3 readings, AM Pre-BD from morning value)]/[(highest PM Post-BD + highest AM Pre-BD)/2] * 100}
Exclusion Criteria:
Contacts and Locations| Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
| United States, California | |
| Investigational Site 26 | Active, not recruiting |
| Los Angeles, California, United States, 90025 | |
| Investigational Site 12 | Withdrawn |
| San Diego, California, United States, 92103-8415 | |
| United States, Colorado | |
| Investigational Site 9 | Completed |
| Denver, Colorado, United States, 80206 | |
| United States, Ohio | |
| Investigational Site 14 | Completed |
| Cincinnati, Ohio, United States, 45231 | |
| United States, Pennsylvania | |
| Investigational Site 11 | Completed |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Washington | |
| Investigational Site 13 | Completed |
| Seattle, Washington, United States, 98105 | |
| United States, Wisconsin | |
| Investigational Site 18 | Active, not recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Canada | |
| Investigational Site 19 | Recruiting |
| Hamilton, Canada, L8N 3Z5 | |
| Investigational Site 5 | Recruiting |
| Montreal, Canada, H4J 1C5 | |
| Investigational Site 6 | Completed |
| Calgary, Canada, T2N 4N1 | |
| Investigational Site 20 | Completed |
| Edmonton, Canada, T6G 2B7 | |
| Investigational Site 30 | Recruiting |
| Mississauga, Canada, L5A 3V4 | |
| Denmark | |
| Investigational Site 3 | Completed |
| Kobenhavn NV, Denmark, 2400 | |
| Investigational Site 4 | Completed |
| Aalborg, Denmark, 9000 | |
| Germany | |
| Investigational Site 21 | Active, not recruiting |
| Grosshansdorf, Germany, 22927 | |
| Investigational Site 22 | Active, not recruiting |
| Berlin, Germany, 10717 | |
| Investigational Site 24 | Active, not recruiting |
| Berlin, Germany, 14050 | |
| Investigational Site 1 | Active, not recruiting |
| Ruedersdorf, Germany, 15562 | |
| Investigational Site 23 | Active, not recruiting |
| Berlin, Germany, 10717 | |
| Investigational Site 25 | Active, not recruiting |
| Mainz, Germany, 55131 | |
| Investigational Site 28 | Recruiting |
| Lubeck, Germany, 23552 | |
| Investigational Site 29 | Recruiting |
| Jena, Germany, 07740 | |
| Sweden | |
| Investigational Site 7 | Recruiting |
| Lund, Sweden | |
| Investigational Site 27 | Recruiting |
| Linkoping, Sweden, 581 85 | |
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: | June 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00635882 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
mometasone formoterol |
|
Anti-Inflammatory Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Adrenergic beta-Agonists Mometasone furoate Anti-Asthmatic Agents Asthma Anti-Allergic Agents Adrenergic Agonists |
Inflammation 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 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 |