Control of Asthma Patients Symptomatic on Inhaled Corticosteroids

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330070
• Other study ID #: IPL512,602-2002
• Secondary ID: CAPSICSEudraCT 2
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2006
• Last updated: February 14, 2007
• Start date: May 2006
• Est. completion date: January 2007

Study information

• Verified date: February 2007
• Source: Inflazyme Pharmaceuticals Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlPoland: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• IPL512,602 20 mg once daily

• IPL512,602 Matching Placebo once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Inflazyme Pharmaceuticals Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AQLQ(S) overall scores from baseline to 8 weeks post-randomization
Secondary	Change in AQLQ(S) individual domain scores
Secondary	Change in asthma control
Secondary	Change in FEV1
Secondary	Change in morning and evening PEFR
Secondary	Change in SABA usage
Secondary	Change in nighttime awakenings
Secondary	Total number of asthma worsening events
Secondary	Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)