Early Antiinflammatory Treatment of Asthma (EATA)

February 10, 2011 updated by: Laval University

Early Anti-inflammatory Treatment of Asymptomatic or Mildly Symptomatic Airway Hyperresponsiveness

  • The inflammatory process that leads to the development of asthma may be present before the onset of asthma symptoms and cause a certain degree of airway hyperresponsiveness. Without treatment it may induce irreversible airway structural changes that are associated with permanent changes in airway functions, persistent airway hyperresponsiveness and lead to the development of asthma symptoms.
  • Atopic subjects with asymptomatic airway hyperresponsiveness and first degree relatives with a history of asthma are at higher risk to develop symptomatic asthma. Early treatment of airway inflammation in these predisposed subjects with " borderline " or mild airway hyper-responsiveness could prevent the development of asthma symptoms, and reduce or even normalize airway responsiveness.
  • In very mild asthmatic subjects (bronchodilator need < thrice a week), early anti-inflammatory treatment can lead to " normalisation " or airway responsiveness in a significant number of subjects and prevent the need for subsequent regular therapy. This is particularly true for those showing blood/sputum eosinophilia.

Objectives: To compare perception of bronchoconstriction, pulmonary function and airway inflammation in subjects with mild symptomatic asthma and asymptomatic asymptomatic airway hyperresponsiveness

Methods: To compare the influence of inhaled fluticasone propionate 250 mcg/day for 3 months followed by 100 mcg/day for 9 months on airway inflammation and methacholine responsiveness in a double-blind, placebo-controlled, parallel groups study including non-smoking atopic subjects with mild asthma and asymptomatic airway hyperresponsiveness

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

  • Evaluate the change in airway hyperresponsiveness and in inflammatory markers in the blood and sputum in the population studied following a 3-month course of fluticasone 250 µg per day followed by a 9-month course of fluticasone 1000 µg per day (before supper) compared to placebo as measured on a regular basis over a two year period.

  • This study will include:

    1. A baseline evaluation period of 2 weeks before starting the 3-month treatment period followed by the 9-month treatment period.
    2. Treatment will be double-blinded, randomized, parallel design.
    3. A follow-up period of one year.

Optional: Bronchoscopies with bronchial biopsy sampling will be performed before and after tratment in a subgroup of subjects to determine what is the influence of this corticosteroid treatment on airway inflammation and remodelling.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Centre de Recherche, Hôpital Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men or women 18 to 45 years old.
  2. Methacholine PC20 0,5-16 mg/ml and FEV1 greater than 80% pred.

  3. Asymptomatic AHR patients will have had no past or present symptoms of intermittent dyspnea or wheezing, chronic cough or phlegm production as defined by negative responses to the European community respiratory health survey (ECRHS) questionnaire. They will also never have experienced symptoms similar to those induced by the methacholine challenge (misinterpretation of asthma symptoms).

    Subjects with mild intermittent symptoms will have had asthma symptoms less than twice a week in the last 3 months. They will, however, demonstrate variable airflow obstruction according to the Canadian asthma consensus criteria. They will have required asthma medication at least occasionnally within the last year.

  4. At least one positive response to indoor allergens (cats, dogs, housedust mites or cockroach).
  5. At least one first degree relative with asthma.
  6. Current exposure to a dog or a cat at home.
  7. FEV1 greater than 80% of predicted (Knudson 1983).

Exclusion Criteria:

  1. Subjects who have used inhaled corticosteroids or any other bronchial anti-inflammatory agents in the past.
  2. Subjects who smoked more than 6 packs/year, or who smoked in the last twelve months.
  3. Poor-perceivers of airflow obstruction (Borg score = 1 on methacholine challenge at 20% fall in FEV1).
  4. Women either pregnant or breastfeeding or those without adequate contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo inhalator will be used by subjects in the placebo group(same course as patients in the treated group)
Device: Fluticasone
Fluticasone 250mcg for 3 months followed by 100mcg for 9 months, one puff once a day at supper time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the change in airway hyperresponsiveness in the population studied following 3-month of fluticasone 250 µg per day followed by 9-month of fluticasone 1000 µg per day compared to placebo.
Time Frame: measurements every 3 months for 2 years
measurements every 3 months for 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
- Evaluate the change in inflammatory markers in blood and sputum vs placebo. - Determine if this treatment will reduce asthma symptoms over a period of 2 years. - Determine its influence on airway inflammation and remodelling (bronchial biopsies).
Time Frame: measurements every 3 months during two years
measurements every 3 months during two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimate)

December 5, 2007

Study Record Updates

Last Update Posted (Estimate)

February 11, 2011

Last Update Submitted That Met QC Criteria

February 10, 2011

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL-EATA-550

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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