Status:
COMPLETED
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Ecole des Hautes Etudes en Santé Publique
Institut de Recherche et Documentation en Economie de la Santé, France
Conditions:
Asthma
Eligibility:
All Genders
6-44 years
Phase:
NA
Brief Summary
Asthma is one of the most prevalent chronic respiratory diseases, with potential lifethreatening impacts. Indeed, asthma is still responsible for about a thousand deceases per year in France, and cons...
Detailed Description
Methodology/Study schedule : A prospective multicenter randomised, open label, controlled trial with blind evaluation of the primary evaluation criterion on three parallel groups of patients. Proced...
Eligibility Criteria
Inclusion
- age greater than or equal to 6 years and less than 45 (\<45 years),
- patients with an eligible control level of asthma,
- sensitization to one or more allergens demonstrated during the last 36 months with prick tests (papules with a diameter \> 3 mm compared to a negative control or \> 50% of positive control) and/or specific IgE detection (\> 0.10 U/mL),
- patients \> 15 years presenting with a reversibility to ß2-agonists \> 200 mL and/or \> 12% compared to the initial FEV1 value (test performed at least once in life) or patients ≥ 6 years and ≤ 15 years presenting with a reversibility to ß2-agonists \> 200 mL and/or \> 12% compared to the initial FEV1 value (at least once in the life) and/or a positive metacholine challenge (at least once in the life),
- patients sleeping \> 6 nights per week in the same house
- individuals affiliated to 1 of the 3 French social security (for matching data from French social security via SNIIRAM system),
- Only one patient per dwelling,
- Patient oral consent (written attestation by investigator)
Exclusion
- chronic obstructive pulmonary disease (COPD),
- identified occupational asthma,
- Move within the 6 months before home intervention or predicted during the first year of inclusion,
- advices provided during the 2 years before inclusion during a home intervention of a MIEC
- active smokers or smoker who given up smoking less than 5 years ago, with a consumption of more than 10 years of 20 cigarettes/day, OR smoker who given up smoking more than 5 years ago, with a consumption of more than 20 years of 20 cigarettes/day,
- patients \< 18 years for whom the parents (or legal guardian) are opposed to the inclusion in ECENVIR study,
- Major people being the object of a legal protection (protection(saving) of justice, guardianship, supervision(guardianship)) and private persons of freedom
Key Trial Info
Start Date :
September 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2020
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT02212483
Start Date
September 5 2014
End Date
March 5 2020
Last Update
May 24 2023
Active Locations (16)
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1
Strasbourg UH
Strasbourg, Alsace, France
2
Aix-en-Provence Hospital
Aix-en-Provence, France, 13616
3
Bordeaux University Hospital
Bordeaux, France, 33076
4
Caen University Hospital
Caen, France, 14033