Control of Asthma Patients Symptomatic on Inhaled Corticosteroids

An 8 Week, Randomized, Double-Blind, Parallel Group, Multicenter Trial Comparing the Efficacy and Safety of Oral IPL512,602 to Placebo in Subjects With Moderate to Severe Persistent Asthma Inadequately Controlled on Inhaled Corticosteroids

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: IPL512,602 20 mg once daily; Drug: IPL512,602 Matching Placebo once daily

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 short-acting β2-agonists (SABAs). Subjects who pass screening at Visit 1 will enter a 2-3 week baseline period to confirm stable asthma symptoms and collect baseline data. Subjects will continue with ongoing prescribed treatment during this period, or as modified by the investigator based on clinical judgment. Subjects will use the SABA prescribed for them to alleviate asthma symptoms on an as needed basis throughout the study. If eligible, at Visit 2 subjects will be randomized to treatment with either IPL512,602 (20 mg) daily or placebo in a 1:1 ratio. Randomization in each treatment group will be stratified into two subgroups: those receiving low to medium doses of inhaled corticosteroids (≤500 µg per day fluticasone or equivalent) and those receiving high doses of inhaled corticosteroids (>500 µg per day fluticasone or equivalent). During the 8-week treatment period, subjects will return to the clinic after 1, 2, 4, 6, and 8 weeks of treatment (Visits 3-7). Adverse event data will be collected for 14 days following the last dose administration (Visit 8).

• Study Type: Interventional
• Enrollment: 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • West Coast Clinical Trials
    • Los Angeles, California, United States, 90025
      • Allergy Research Foundation, Inc.
    • San Diego, California, United States, 92123
      • Asthma Medical Group & Resarch
    • San Jose, California, United States, 95128
      • San Jose Clinical Research
  • Massachusetts
    • No. Dartmouth, Massachusetts, United States, 02743
      • Northeast Medical Research Associates, Inc
  • Oregon
    • Medford, Oregon, United States, 97504
      • Clinical Research Institute of South Oregaon
    • Portland, Oregon, United States, 97231
      • Allergy Associates Research Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in AQLQ(S) overall scores from baseline to 8 weeks post-randomization

Secondary Outcome Measures

Outcome Measure
Change in AQLQ(S) individual domain scores
Change in asthma control
Change in FEV1
Change in morning and evening PEFR
Change in SABA usage
Change in nighttime awakenings
Total number of asthma worsening events
Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)

Collaborators and Investigators

• Sponsor: Inflazyme Pharmaceuticals Ltd
• Investigators: Principal Investigator: Busse William, MD, University of Wisconsin, Madison; Principal Investigator: Jonathan Corren, MD, Allergy Research Foundatin, Inc.; Principal Investigator: Alan Heller, MD, San Jose Clinical Research; Principal Investigator: Edward Kerwin, MD, Clinical Research Institute of South Oregon; Principal Investigator: Y. Hsu, MD, West Coast Clinical Trials; Principal Investigator: Eli Meltzer, MD, Allergy and Asthma Medical Group; Principal Investigator: S. David Miller, MD, Northeast Medical Research Associates; Principal Investigator: Michael J Noonan, Allergy Associates Research Center

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Study Completion: January 1, 2007

Study Registration Dates

• First Submitted: May 23, 2006
• First Submitted That Met QC Criteria: May 23, 2006
• First Posted (Estimate): May 25, 2006

Study Record Updates

• Last Update Posted (Estimate): February 16, 2007
• Last Update Submitted That Met QC Criteria: February 14, 2007
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Keywords: quality of life; asthma control; AQLQ; oral tablets; 8-week treatment; persistent moderate to severe asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: IPL512,602-2002; CAPSICS; EudraCT 2006-000840-22