Condition category
Respiratory
Date applied
09/02/2009
Date assigned
03/07/2009
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mstwente.nl

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

Publication citations

Additional files

Editorial Notes