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
Protocol serial number	IJsbaan 1-003
Sponsor	Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)
Funder	Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)

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

Haaksbergerstraat 55
VKC poli 17
Enschede
7513 ER
Netherlands

Phone	+31 (0)53 487 2310
Email	jeandriessen@hotmail.com

Study information

Primary study design	Interventional
Study design	Double-blind randomised cross-over placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase III
Drug / device / biological / vaccine name(s)	Fluticasone propionate
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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).
Completion date	01/04/2005

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	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

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