Contact information
Type
Scientific
Primary contact
Mrs Janneke van Leeuwen
ORCID ID
Contact details
Ariensplein 1
Enschede
75 11 JX
Netherlands
+31 (0) 53 487 2310
J.C.van.Leeuwen@student.rug.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FF1, NL26953.044.09
Study information
Scientific title
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
Acronym
YSCO
Study hypothesis
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).
Ethics approval
Medical Ethical Review Committee (METC), Medical Centre Twente (Medisch Spectrum Twente), Enschede, approval pending as of 03/07/2009.
Study design
Randomised double-blind placebo-controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Allergic rhinitis and exercise induced asthma in children
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Fluticasone furoate (Avamys®)
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
05/03/2009
Overall trial end date
05/04/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
91
Participant 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
Recruitment start date
05/03/2009
Recruitment end date
05/04/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Ariensplein 1
Enschede
75 11 JX
Netherlands
Sponsor information
Organisation
Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)
Sponsor details
Ariensplein 1
Enschede
7511 JX
Netherlands
+31 (0) 53 487 2310
kindergeneeskunde@ziekenhuis-mst.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Paediatric Research Foundation Enschede, Medical Centre Twente (Stichting Pediatrisch Onderzoek Enschede, Medisch Spectrum Twente) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary