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
Secondary identifying numbers FF1, NL26953.044.09
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

Study designRandomised double-blind placebo-controlled single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe 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 acronymYSCO
Study objectivesThree 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) studiedAllergic rhinitis and exercise induced asthma in children
InterventionThree 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Fluticasone furoate (Avamys®)
Primary outcome measure1. 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 measures1. 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 study start date05/03/2009
Completion date05/04/2009

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit12 Years
Upper age limit17 Years
SexBoth
Target number of participants91
Key inclusion criteria1. 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 criteria1. 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 enrolment05/03/2009
Date of final enrolment05/04/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Ariensplein 1
Enschede
75 11 JX
Netherlands

Sponsor information

Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)
Hospital/treatment centre

Ariensplein 1
Enschede
7511 JX
Netherlands

Phone +31 (0) 53 487 2310
Email kindergeneeskunde@ziekenhuis-mst.nl
Website http://www.mstwente.nl
ROR logo "ROR" https://ror.org/033xvax87

Funders

Funder type

Hospital/treatment centre

Paediatric Research Foundation Enschede, Medical Centre Twente (Stichting Pediatrisch Onderzoek Enschede, Medisch Spectrum Twente) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan