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?

Status Recruiting

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.

Clinical Trial Description

n/a

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

• NCT number: NCT00509197
• Study type: Interventional
• Source: Université de Montréal
• Contact: Catherine Lemiere, MD,MSc
• Phone: 514 338 2796
• Email: catherine.lemiere@umontreal.ca
• Status: Recruiting
• Phase: N/A
• Start date: October 2007
• Completion date: September 2010