Status:
COMPLETED
Study of Dose-response to Bronchodilator and Dose-finding in Child 2.5 to 6 Years - Study Golden
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Asthma
Eligibility:
All Genders
2-6 years
Phase:
PHASE2
Brief Summary
In older children and adults, bronchodilator (BD) dose-effect relationship is part of the characteristics of asthma disease. There are no data on BD dose-response relationship in wheezy preschool chil...
Detailed Description
In older children and adults, bronchodilator (BD) dose-effect relationship is part of the characteristics of asthma disease. There are no data on BD dose-response relationship in wheezy preschool chil...
Eligibility Criteria
Inclusion
- Any patient between 2 years 6 months and 6 years 11 months of age referred for pulmonary function testing with bronchodilator test, due to recurrent wheezing ,at least three times in the past year, to LFT laboratories at Armand Trousseau, Robert Debré, both in Paris and Arnaud de VILLENEUVE, in Montpellier hospitals
- No use of bronchodilator in the previous 12 hours before the test
- Parents gave their signed consent for the study
Exclusion
- Any patient aged 2 years 6 months and 6 years 11 months :
- with another chronic lung disease (bronchopulmonary dysplasia, chronic bronchitis, viral sequel, pathology of inhalation, thoracic-pulmonary malformation, tracheomalacia), anatomical or functional abnormality of the pharyngolaryngeal tract (tonsils touching or in contact with the uvula, laryngomalacia, subglottic stenosis, vocal cord paralysis, laryngeal obstruction)
- taking regular treatment including leukotrienes receptor antagonist during the week before the test.
- treated with oral glucocorticosteroids within 15 days before the test.
- without social security insurance
- with opposition of the family
- known intolerant to Salbutamol
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01470755
Start Date
January 1 2012
End Date
January 1 2014
Last Update
February 6 2023
Active Locations (1)
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1
Beydon
Paris, France, 75012