Early Antiinflammatory Treatment of Asthma (EATA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00567463
Recruitment Status : Terminated (Completed)
First Posted : December 5, 2007
Last Update Posted : February 11, 2011
Information provided by:
Laval University

Brief Summary:
  • 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 or disease Intervention/treatment Phase
Asthma Bronchial Hyperreactivity Device: Fluticasone Not Applicable

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  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Early Anti-inflammatory Treatment of Asymptomatic or Mildly Symptomatic Airway Hyperresponsiveness
Study Start Date : December 1998
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. - 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00567463

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

Responsible Party: Louis-Philippe Boulet, Laval Hospital Identifier: NCT00567463     History of Changes
Other Study ID Numbers: HL-EATA-550
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: December 2007

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

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