Should Non-Eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?

Non-Eosinophilic Asthma Clinical Trial

Official title:

Should Non-Eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00509197
• Other study ID #: SFA110717
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2007
• Last updated: February 12, 2009
• Start date: October 2007
• Est. completion date: September 2010

Study information

• Verified date: February 2009
• Source: Université de Montréal
• Contact: Catherine Lemiere, MD,MSc
• Phone: 514 338 2796
• Email: catherine.lemiere[@]umontreal.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The efficacy of inhaled corticosteroids (ICS) in asthmatic subjects showing no sputum eosinophils is controversial. The broad aim of this study is to assess whether ICS alone or in combination with long-acting beta-2 agonists are an effective treatment in non-eosinophilic asthmatic subjects. Methods: The investigators will perform a randomized double-blind, placebo-controlled, multicenter study comparing the efficacy of ICS and placebo for 4 weeks followed by a 4-week open treatment period with ICS/salmeterol in steroid-naïve asthmatic subjects without sputum eosinophilia. The primary outcome will be the the Asthma Control Questionnaire (ACQ) score after four weeks of treatment by ICS or placebo.

This study will determine whether or not non-eosinophilic asthmatic subjects respond to ICS and if they further benefit from the addition of a long-acting beta-2 agonists. This study will also determine whether or not the assessment of airway inflammation should be performed in every asthmatic patient in order to give the most appropriate treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Are between 18 and 70 years of age at the time of signing the informed consent.

• Have a diagnosis of asthma according to the Guidelines for the Diagnosis and Management of Asthma and have not been treated with ICS in the previous two months.

• Have a PC20 methacholine less than 8 mg/ml.

• Have a baseline FEV1 greater or equal to 65% of predicted value (at least 6 hours after bronchodilator).

• Are not optimally controlled with short-acting 2 agonists as shown by awakenings due to asthmatic symptoms at least once a week, or regular use of salbutamol on 4 or more occasions per week (excluding exercise prophylaxis) due to asthma symptoms.

• ACQ score equal or greater than 2

• Have sputum eosinophils less than 2%

• Are non smokers or ex-smokers who smoked a maximum of 10 pack/year.

Exclusion Criteria:

• Hospitalized patients within the last 3 months

• Current or recent (within the last month) symptoms of a cold or flu

• Patients with a history of near fatal asthma

• Subjects on inhaled corticosteroids, prednisone, long-acting beta 2 agonists, montelukast or theophylline, within 2 months prior to entry into the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non-Eosinophilic Asthma

Intervention

Drug:
• Placebo
Fluticasone 250 mcg bid
• Fluticasone
Fluticasone 250mcg bid for one month

Locations

Country	Name	City	State
Canada	Firestone Institute for Respiratory Health	Hamilton	Ontario
Canada	The Meakins-Christie Laboratories	Montreal	Quebec
Canada	Hôpital du Sacré-Coeur de Montréal	Montréal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Hôpital Laval	Quebec
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Université de Montréal	Laval University, McGill University, University of British Columbia, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire (ACQ) score after 4 weeks of treatment with ICS or placebo		two years	No
Secondary	Asthma Quality of Life Questionnaire (AQLQ) score after 4 weeks of treatment		Two years	No
Secondary	Change in FEV1		Two years	No
Secondary	Change in PC20		Two years	No