Effect of a single high dose of inhaled steroid on exercise induced laryngeal narrowing and bronchial asthma in children aged 12 - 17 years

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61380683

Enrollment

Registered

2009-12-08

Start date

2005-02-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise induced asthma Respiratory Asthma

Interventions

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 i

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026