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

NCT00509197 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-08-15

Study results available
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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.

Conditions

Interventions

DRUG

Placebo (sham inhaler)

DRUG

Fluticasone

Fluticasone 250mcg bid for one month

Sponsors & Collaborators

  • University of Ottawa

    collaborator OTHER

  • Laval University

    collaborator OTHER

  • University of British Columbia

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • University of Calgary

    collaborator OTHER

  • Université de Montréal

    lead OTHER

Principal Investigators

  • Catherine Lemiere, MD,MSc · Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-05-31
Completion
2010-09-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00509197 on ClinicalTrials.gov