Control of Asthma Patients Symptomatic on Inhaled Corticosteroids - Full Text View

Sponsored by:	Inflazyme Pharmaceuticals Ltd
Information provided by:	Inflazyme Pharmaceuticals Ltd
ClinicalTrials.gov Identifier:	NCT00330070

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: IPL512,602 20 mg once daily Drug: IPL512,602 Matching Placebo once daily	Phase II

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Inflazyme Pharmaceuticals Ltd:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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)

Estimated Enrollment:	200
Study Start Date:	May 2006
Estimated Study Completion Date:	January 2007

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).

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330070

Locations

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

Sponsors and Collaborators

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

More Information

Study ID Numbers:	IPL512,602-2002, CAPSICS, EudraCT 2006-000840-22
Study First Received:	May 23, 2006
Last Updated:	February 14, 2007
ClinicalTrials.gov Identifier:	NCT00330070
Health Authority:	United States: Food and Drug Administration; Bulgaria: Bulgarian Drug Agency; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Ukraine: Ministry of Health

Keywords provided by Inflazyme Pharmaceuticals Ltd:

8-week treatment
oral tablets
persistent moderate to severe asthma

AQLQ
asthma control
quality of life

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Quality of Life
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 15, 2009