Early Antiinflammatory Treatment of Asthma

NCT00567463 | Terminated

• 1 other identifier: HL-EATA-550
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma; Bronchial Hyperreactivity

Keywords

Asthma; Bronchial hyperresponsiveness; Methacholine; Induced sputum; bronchial biopsies

Outcome Measures

Primary Outcomes (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.

  measurements every 3 months for 2 years

Secondary Outcomes (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).

  measurements every 3 months during two years

Study Arms (1)

Placebo

PLACEBO COMPARATOR

Placebo inhalator will be used by subjects in the placebo group(same course as patients in the treated group)

Device: Fluticasone

Interventions

Fluticasone DEVICE

Fluticasone 250mcg for 3 months followed by 100mcg for 9 months, one puff once a day at supper time

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women 18 to 45 years old.
• Methacholine PC20 0,5-16 mg/ml and FEV1 greater than 80% pred.
• 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.
• At least one positive response to indoor allergens (cats, dogs, housedust mites or cockroach).
• At least one first degree relative with asthma.
• Current exposure to a dog or a cat at home.
• FEV1 greater than 80% of predicted (Knudson 1983).

You may not qualify if:

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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Centre de Recherche, Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Asthma; Bronchial Hyperreactivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Louis-Philippe Boulet, MD

  Hôpital Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 5, 2007
• Study Start: December 1, 1998
• Study Completion: December 1, 2005
• Last Updated: February 11, 2011

Record last verified: 2007-12

Locations

CA (1)