Exercise induced airway obstruction MedDRA version: 9.1 Level: LLT Classification code 10003557 Term: Asthma exercise induced MedDRA version: 9.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis
Conditions
Interventions
Trade Name: Avamys
Product Name: fluticasone furoate
Product Code: fluticasone furoate
Pharmaceutical Form: Nasal spray, emulsion
Pharmaceutical form of the placebo: Nasal drops, emulsion
Route of adm
Sponsors
Stichting Pediatrisch Onderzoek Enschede
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Clinical history of allergic rhinitis and/or allergic asthma. - Age between 12 and 17 years. - Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Use of intranasal or systemic corticosteroids in the last 4 weeks prior to the study. - Use of antihistamines, cromoglycates, anticholinergics in two weeks prior to the study. - Use of long acting bronchodilators 24 hours before testing. - Use of short acting bronchodilators 8 hours before testing. - Use of systemic corticosteroids, antihistamines, cromoglycates, anticholinergics, during the study. - Other pulmonary or cardiac disorder. - Deviation of the FEV1 of more than 12 % from baseline spirometry and the FEV1 before subsequent exercise provocation challenges. - Signs of gastro-esophageal reflux.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Analyze the reduction in exercise induced fall of FEV1 and MIF50 after three weeks of treatment with fluticasone furoate. ;Secondary Objective: •Analyze the reduction in exercise induced increase of airway resistance, measured with the FOT, after three weeks of treatment with fluticasone furoate. •Analyze the reduction in exercise induced decrease of airway reactance, measured with the FOT, after three weeks of treatment with fluticasone furoate. •Analyze the reduction in FeNO, measured with the FOT, after three weeks of treatment with fluticasone furoate. •Analyze the increase in quality of life, measured with the PAQLQ, after three weeks of treatment with fluticasone furoate. •Analyze the increase in control of asthma, measured with the ACQ, after three weeks of treatment with fluticasone furoate. ;Primary end point(s): o Analyze the reduction in exercise induced fall of FEV1 after three weeks of treatment with fluticasone furoate. o Analyze the reduction in exercise induced fall of MIF50 after three weeks of treatment with fluticasone furoate. | — |
Countries
Netherlands
Outcome results
None listed