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

ISRCTN	ISRCTN90761040
DOI	https://doi.org/10.1186/ISRCTN90761040
Protocol serial number	FF1, NL26953.044.09
Sponsor	Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)
Funder	Paediatric Research Foundation Enschede, Medical Centre Twente (Stichting Pediatrisch Onderzoek Enschede, Medisch Spectrum Twente) (Netherlands)

Submission date: 09/02/2009
Registration date: 03/07/2009
Last edited: 03/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Janneke van Leeuwen
Scientific

Ariensplein 1
Enschede
75 11 JX
Netherlands

Phone	+31 (0) 53 487 2310
Email	J.C.van.Leeuwen@student.rug.nl

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	YSCO
Study objectives	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(s)	Medical Ethical Review Committee (METC), Medical Centre Twente (Medisch Spectrum Twente), Enschede, approval pending as of 03/07/2009.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Fluticasone furoate (Avamys®)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	05/04/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Years
Upper age limit	17 Years
Sex	All
Target sample size at registration	91
Key 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
Key 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
Date of first enrolment	05/03/2009
Date of final enrolment	05/04/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Ariensplein 1

Enschede
75 11 JX
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes