Status:
COMPLETED
Control of Asthma Patients Symptomatic on Inhaled Corticosteroids
Lead Sponsor:
Inflazyme Pharmaceuticals Ltd
Conditions:
Asthma
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether IPL512,602 is safe and effective for the treatment of asthma symptoms in patients who remain symptomatic on a background therapy of inhaled corticoster...
Detailed Description
This multicenter, randomized, double-blind, placebo-controlled, parallel group study will include subjects with persistent moderate to severe asthma who require inhaled corticosteroids and inhaled sho...
Eligibility Criteria
Inclusion
- a history of persistent asthma for at least the 4 months prior to entry
- require daily inhaled corticosteroids (220-1000 µg fluticasone equivalent per day) for at least 4 weeks prior to randomization and short-acting beta-2-agonist (SABA)
- FEV1 at randomization (without exposure to a SABA for at least 6 hours) must be between 50% and 80% of predicted normal
- reversibility of FEV1 by at least 12% and at least 250 mL following two to four inhalations of a SABA must be demonstrated prior to randomization
- AQLQ(S) score of 4.5 or less at both the screening (Visit 1) and randomization (Visit 2) visits
- patients must meet at least two out of three of the following criteria:
- overall score minimum of 2 on Asthma Control Questionnaire (ACQ)
- require rescue SABA use of 2 or more inhalations per day for symptom relief on at least 4 of 7 days during each week of the baseline period
- nighttime awakenings due to asthma, an average of at least once a week during the baseline period
Exclusion
- history of chronic pulmonary diseases other than asthma, including bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, cystic fibrosis, pulmonary tuberculosis, or bronchiectasis
- other asthma therapies:
- use of long-acting beta-2-agonists within 5 weeks prior to randomization
- use of leukotriene modulators, theophylline, or muscarinic antagonists within 4 weeks prior to randomization
- use of injectable or oral corticosteroids within 2 months prior to screening
- requirement for more than 10 inhalations per day of a short-acting beta-2-agonist more than 3 times per week during the baseline period
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00330070
Start Date
May 1 2006
End Date
January 1 2007
Last Update
February 16 2007
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
West Coast Clinical Trials
Long Beach, California, United States, 90806
2
Allergy Research Foundation, Inc.
Los Angeles, California, United States, 90025
3
Asthma Medical Group & Resarch
San Diego, California, United States, 92123
4
San Jose Clinical Research
San Jose, California, United States, 95128