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ISRCTN
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ISRCTN90761040
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ClinicalTrials.gov identifier
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Public title
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The protective effect of a nasal corticosteroid (Avamys®) on exercise induced airway obstruction in cold air in children
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Scientific title
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The protective effect of a nasal corticosteroid (Avamys®) on exercise induced airway obstruction in cold air in children: a randomised double-blind placebo-controlled single-centre trial
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Acronym
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YSCO
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Serial number at source
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FF1, NL26953.044.09
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Study hypothesis
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Three weeks of treatment with fluticasone furoate (Avamys®) in children will reduce exercise induced fall in forced expiratory volume in one second (FEV1) and maximum inspiratory flow rate at 50% of vital capacity (MIF50).
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Ethics approval
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Medical Ethical Review Committee (METC), Medical Centre Twente (Medisch Spectrum Twente), Enschede, approval pending as of 03/07/2009.
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Study design
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Randomised double-blind placebo-controlled single-centre trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Allergic rhinitis and exercise induced asthma in children
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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05/03/2009
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Anticipated end date
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05/04/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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91
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Interventions
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Three weeks +/- 5 days of treatment with fluticasone furoate (Avamys®) or placebo. Avamys® will be administered through a nasal spray, once daily, 27.5 µg in each nostril. In the first week of the study there will be a double dosing.
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Primary outcome measure(s)
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1. Analyse the reduction in exercise induced fall of FEV1 after three weeks of treatment with fluticasone furoate
2. Analyse the reduction in exercise induced fall of MIF50 after three weeks of treatment with fluticasone furoate
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Secondary outcome measure(s)
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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
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
3. Analyze the reduction in fractional exhaled nitric oxide (FeNO), measured with miniNIOX® after three weeks of treatment with fluticasone furoate
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
5. To analyse the increase in control of asthma, measured with the Asthma Control Questionnaire (ACQ), after three weeks of treatment with fluticasone furoate
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Sources of funding
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Paediatric Research Foundation Enschede, Medical Centre Twente (Stichting Pediatrisch Onderzoek Enschede, Medisch Spectrum Twente) (Netherlands)
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Trial website
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Publications
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Contact name
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Mrs
Janneke
van Leeuwen
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Address
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Ariensplein 1
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City/town
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Enschede
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Zip/Postcode
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75 11 JX
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Country
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Netherlands
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Tel
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+31 (0) 53 487 2310
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Email
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J.C.van.Leeuwen@student.rug.nl
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Sponsor
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Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)
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Address
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Ariensplein 1
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City/town
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Enschede
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Zip/Postcode
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7511 JX
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Country
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Netherlands
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Tel
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+31 (0) 53 487 2310
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Fax
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+31 (0) 53 487 2326
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Email
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kindergeneeskunde@ziekenhuis-mst.nl
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Sponsor website:
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http://www.mstwente.nl
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Date applied
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09/02/2009
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Last edited
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03/07/2009
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Date ISRCTN assigned
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03/07/2009
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