Effect of a single high dose of inhaled steroid on exercise induced laryngeal narrowing and bronchial asthma in children aged 12 - 17 years
| ISRCTN | ISRCTN61380683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61380683 |
| Secondary identifying numbers | IJsbaan 1-003 |
- Submission date
- 08/10/2009
- Registration date
- 08/12/2009
- Last edited
- 08/12/2009
- 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
Mr Jean Driessen
Scientific
Scientific
Haaksbergerstraat 55
VKC poli 17
Enschede
7513 ER
Netherlands
| Phone | +31 (0)53 487 2310 |
|---|---|
| jeandriessen@hotmail.com |
Study information
| Study design | Double-blind randomised cross-over placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Single high dose of inhaled steroid on exercise induced laryngeal narrowing and bronchial asthma in children: a double-blind randomised cross-over placebo controlled trial |
| Study acronym | IJsbaan-studie |
| Study objectives | Exercise-induced asthma can be reduced with a single high dose of corticosteroids. There is however a large variety of response within patient groups. In clinical practice children report a wheeze, and inspiratory stridor, a sign of extra-thoracic airway obstruction. With the use of full flow-volume loops an analysis can be made of intrathoracic (forced expiratory volume in one second [FEV1]) and extra-thoracic (mid-inspiratory flow [MIF50]) airway obstruction. The forced oscillation technique can be used to accurately evaluate reactance and resistance of intra-thoracic airways. The aim of this study was to evaluate the effect of a single high dose of fluticasone propionate with the expiratory flow loop and the forced oscillation technique, and evaluate the drop in MIF50 after exercise. |
| Ethics approval(s) | The local medical ethics committee (Medisch Etidsche Toetsingcommissie [METC]) Medisch Spectrum Twente (MST) Enschede approved on the 11th January 2005 (ref: P04-017). Date of ABR signing: 27th April 2004, Version: Juli 2002. |
| Health condition(s) or problem(s) studied | Exercise induced asthma |
| Intervention | Four hours after inhalation of a single dose of either placebo or 1 mg fluticasone propionate children will perform an exercise challenge in cold, dry air. After 6 - 14 days children will cross-over in medication and will perform another exercise provocation challenge. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Fluticasone propionate |
| Primary outcome measure | The difference in drop of FEV1 after exercise between fluticasone propionate and placebo, measured before and 1, 3, 6, 8, 12, 15, 20, 25 and 30 minutes after exercise. All measurements were repeated 10 minutes after administration of 200 μg of salbutamol (a reliever drug). |
| Secondary outcome measures | 1. The change in increase of resistance after exercise between fluticasone propionate and placebo, measured before and at 5, 14 and 24 minutes after exercise 2. The change in decrease of reactance after exercise between fluticasone propionate and placebo, measured before and at 5, 14 and 24 minutes after exercise 3. The drop in MIF50 after exercise, measured before and 1, 3, 6, 8, 12, 15, 20, 25 and 30 minutes after exercise All measurements were repeated 10 minutes after administration of 200 μg of salbutamol (a reliever drug). |
| Overall study start date | 01/02/2005 |
| Completion date | 01/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 23 |
| Key inclusion criteria | 1. Clinical history of airway obstruction after exercise 2. A drop of FEV1 of at least 10% after exercise 3. Aged between 12 and 17 years, either sex 4. Ability to perform reproducible lung function tests, i.e., coefficient of the predicted value variation in three of five consecutive measurements less than 5% 5. FEV1 greater than 70% of predicted value 6. Clinically stable period of at least 3 weeks before the study period |
| Key exclusion criteria | 1. Use of inhaled, intranasal or systemic corticosteroids in the last 4 weeks prior to the study 2. Use of anti-histamines, leucotrienes receptor antagonists, cromoglycates, anticholinergics and long acting bronchodilators in two weeks prior to the study 3. Other pulmonary or cardiac disorder 4. Deviation of more than 12% from baseline spirometry at a subsequent exercise challenge |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 01/04/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Haaksbergerstraat 55
Enschede
7513 ER
Netherlands
7513 ER
Netherlands
Sponsor information
Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)
Research organisation
Research organisation
Haaksbergerstraat 55
VKC poli 17
Enschede
7513 ER
Netherlands
| Phone | +31 (0)53 487 2310 |
|---|---|
| kindergeneeskunde@ziekenhuis-mst.nl | |
| Website | http://www.mst.nl |
"ROR" |
https://ror.org/033xvax87 |
Funders
Funder type
Research organisation
Paediatric Research Foundation Enschede, Medical Centre 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 |
