The protective effect of a nasal corticosteroid (Avamys®) on exercise induced airway obstruction in cold air in childre

Completed

• Conditions: Allergic rhinitis and exercise induced asthma in children; Respiratory; Asthma

• Registration Number: ISRCTN90761040
• Lead Sponsor: Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

1. Both males and females, aged between 12 and 17 years
2. Clinical history of allergic rhinitis and/or allergic asthma
3. Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in three of five consecutive measurements less than 5%
4. Maximal FEV1 greater than 70% of predicted value
5. Clinically stable period at least three weeks before the study period

Exclusion Criteria

1. Use of intranasal or systemic corticosteroids in the last four weeks prior to the study
2. Use of antihistamines, cromoglycates, anticholinergics in two weeks prior to the study
3. Use of long acting bronchodilators 24 hours before testing
4. Use of short acting bronchodilators eight hours before testing
5. Use of systemic corticosteroids, antihistamines, cromoglycates, anticholinergics, during the study
6. Other pulmonary or cardiac disorder
7. Deviation of the FEV1 of more than 12% from baseline spirometry and the FEV1 before subsequent exercise provocation challenges
8. Signs of gastro-oesophageal reflux

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Analyse the reduction in exercise induced fall of FEV1 after three weeks of treatment with fluticasone furoate<br>2. Analyse the reduction in exercise induced fall of MIF50 after three weeks of treatment with fluticasone furoate

Secondary Outcome Measures

Name	Time	Method
1. To analyse the reduction in exercise induced increase of airway resistance, measured with the forced oscillation technique (FOT), after three weeks of treatment with fluticasone furoate<br>2. To analyse the reduction in exercise induced decrease of airway reactance, measured with the forced oscillation technique (FOT), after three weeks of treatment with fluticasone furoate<br>3. Analyze the reduction in fractional exhaled nitric oxide (FeNO), measured with miniNIOX® after three weeks of treatment with fluticasone furoate<br>4. To analyse the increase in quality of life, measured with the Paediatric Asthma Quality of Life Questionnaire (PAQLQ), after three weeks of treatment with fluticasone furoate<br>5. To analyse the increase in control of asthma, measured with the Asthma Control Questionnaire (ACQ), after three weeks of treatment with fluticasone furoate