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

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Université de Montréal
• Collaborators: Laval University; McGill University; University of British Columbia; University of Calgary; University of Ottawa
• Treatments: Fluticasone

Criteria

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.