Control of Asthma Patients Symptomatic on Inhaled Corticosteroids

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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 corticosteroids.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inflazyme Pharmaceuticals Ltd

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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