ISRCTN - ISRCTN61380683: Effect of a single high dose of inhaled steroid on exercise induced laryngeal narrowing and bronchial asthma in children aged 12

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jean Driessen

ORCID ID

Contact details

Haaksbergerstraat 55
VKC poli 17
Enschede
7513 ER
Netherlands
+31 (0)53 487 2310
jeandriessen@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IJsbaan 1-003

Study information

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

Acronym

IJsbaan-studie

Study hypothesis

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

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.

Study design

Double-blind randomised cross-over placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

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 trial start date

01/02/2005

Overall trial end date

01/04/2005

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

23

Participant 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

Recruitment start date

01/02/2005

Recruitment end date

01/04/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Haaksbergerstraat 55
Enschede
7513 ER
Netherlands

Sponsor information

Organisation

Paediatric Research Foundation Enschede, Medical Centre Twente (Netherlands)

Sponsor details

Haaksbergerstraat 55
VKC poli 17
Enschede
7513 ER
Netherlands
+31 (0)53 487 2310
kindergeneeskunde@ziekenhuis-mst.nl