Early Antiinflammatory Treatment of Asthma (EATA)

This study has been terminated.
(Completed)
Sponsor:
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00567463
First received: December 4, 2007
Last updated: February 10, 2011
Last verified: December 2007
  Purpose
  • 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


Condition Intervention
Asthma
Bronchial Hyperreactivity
Device: Fluticasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Early Anti-inflammatory Treatment of Asymptomatic or Mildly Symptomatic Airway Hyperresponsiveness

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - 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 ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: December 1998
Study Completion Date: December 2005
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567463

Locations
Canada, Quebec
Centre de Recherche, Hôpital Laval
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Louis-Philippe Boulet, MD Hôpital Laval
  More Information

No publications provided

Responsible Party: Louis-Philippe Boulet, Laval Hospital
ClinicalTrials.gov Identifier: NCT00567463     History of Changes
Other Study ID Numbers: HL-EATA-550
Study First Received: December 4, 2007
Last Updated: February 10, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Laval University:
Asthma
Bronchial hyperresponsiveness
Methacholine
Induced sputum
bronchial biopsies

Additional relevant MeSH terms:
Asthma
Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 23, 2014