The protective effect of azelastine/fluticasone propionate (Dymista) on exercise-induced asthma

Phase 1

• Conditions: Exercise-induced airway obstruction Asthma Allergic rhinitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-001120-18-NL
• Lead Sponsor: Stichting Pediatrisch Onderzoek Enschede

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-11
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

- Clinical history of allergic rhinitis and EIB (exercise-induced
bronchoconstriction)
- Age between 12 and 18 years.
- Ability to perform spirometry and FOT
Are the trial subjects under 18? yes
Number of subjects for this age range: 64
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Other pulmonary or cardiac illnesses
- Severe EIB i.e. a fall of =40% FEV1 in the first ECT, requiring an acute
change in maintenance medication (standard care)
- Use of long acting bronchodilator agents 24 hours before testing
- Use of short acting bronchodilator agents 8 hours before testing
- Hospitalization due to asthma exacerbation in the last 4 weeks
- Use of intranasal or systemic corticosteroids in the last 4 weeks prior
to the study.
- Use of antihistamines, cromoglycates, anticholinergics in two weeks
prior the study or during the study.
- Other changes in asthma medication during treatment period
- Insufficient knowledge of the Dutch language

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified