Control of Asthma Patients Symptomatic on Inhaled Corticosteroids

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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 corticosteroids.

Key facts

Study ID

NCT00330070

Run by

Inflazyme Pharmaceuticals Ltd

People needed

200

Starts

2006-05-01

Expected to finish

2007-01-01

Last updated by the study team

2007-02-16

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• West Coast Clinical Trials — Long Beach, California, United States
• Allergy Research Foundation, Inc. — Los Angeles, California, United States
• Asthma Medical Group & Resarch — San Diego, California, United States
• San Jose Clinical Research — San Jose, California, United States
• Northeast Medical Research Associates, Inc — No. Dartmouth, Massachusetts, United States
• Clinical Research Institute of South Oregaon — Medford, Oregon, United States
• Allergy Associates Research Center — Portland, Oregon, United States
• University of Wisconsin - Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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