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
Scientific
Ariensplein 1
Enschede
75 11 JX
Netherlands
| Phone | +31 (0) 53 487 2310 |
|---|---|
| J.C.van.Leeuwen@student.rug.nl |
Study information
| Study design | Randomised double-blind placebo-controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fluticasone furoate (Avamys®) |
| Primary outcome measure | 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 study start date | 05/03/2009 |
| Completion date | 05/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 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
75 11 JX
Netherlands
Sponsor information
Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Ariensplein 1
Enschede
7511 JX
Netherlands
| Phone | +31 (0) 53 487 2310 |
|---|---|
| kindergeneeskunde@ziekenhuis-mst.nl | |
| Website | http://www.mstwente.nl |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
