NCT04408664

Influence of Cromones on Eucapnic Hyperventilation (EVH)-Test in Young (Elite) Athletes Who Tested Positive for EIB.

WP3-Influence of Cromones on EVH-test in Young (Elite) Athletes Who Tested Positive for EIB (=Exercise Induced Bronchoconstriction)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blinded, placebo-controlled trial of nebulized Sodium Cromoglycate (SCG) (Lomudal®) versus NaCl0.9% in athletes (11-18 year) with exercise-induced bronchoconstriction (EIB).

Detailed description

Screening and diagnosing EIB (studied by investigators in WP1 (s59778) and WP2 (s61602) of granted FWO-TBM project (T001417N)) in young athletes would only be useful if a safe and effective treatment is available. Sodium Cromoglycate (SCG) has a very nice safety profile but is less effective when compared to inhaled corticosteroids in asthma patients. However, SCG has been shown to be especially effective in exercise-induced asthma and to reduce metabolite secretion in athletes due to hyperpnoea. Although commercial interest in the drug has fainted, from a clinical point of view, it remains the ideal candidate to be used in adolescents with features of EIB at risk to develop asthma in whom today no treatment would be initiated. This clinical trial (s63147), which is WP3 of the FWO-TBM project, is a randomized double-blinded trial with subjects who tested positive for the diagnosis of EIB in either WP1 or WP2. Subjects who gave assent and whose parents gave consent will be randomized (1/1) in a double-blinded trial to receive either (arm 1) Sodium Cromoglycate (SCG) (Lomudal®) or (arm 2) placebo, both 4X1 ampulla (2 mL) in aerosol daily, during 6 months. During the previous trials, several tests were already performed. If subjects want to participate in this trial and the previous tests were more than 1 month ago, some tests will be repeated as a baseline: questionnaires, spirometry (with reversibility test) and EVH-test. After 3 months, regular intake as well as potential side effects will be evaluated. After 6 months, in addition to questionnaires, clinical examination and spirometry with reversibility test, the EVH-test will be repeated. Subjects will also be offered the possibility to repeat (as they did for WP1 and WP2) a blood and sputum sampling at 6 months. Afterwards, subjects will have the option to continue open-label treatment for 6 months. The investigators want to investigate the influence of SCG on EVH-test in young athletes who tested positive for EIB.

Conditions

• Exercise-Induced Bronchoconstriction

Interventions

Type	Name	Description
DRUG	Sodium Cromoglycate	Sodium Cromoglicate 10 mg/mL packed in ampulla of 2 mL; Daily dosis of 4X20 mg milligram delivered by aerosol.
DRUG	Placebo	Sodium Chloride 0.9% packed in ampulla of 2 mL; Daily dosis of 4 ampulla delivered by aerosol.

Timeline

• Start date: 2021-04-06
• Primary completion: 2023-06-28
• Completion: 2023-08-01
• First posted: 2020-05-29
• Last updated: 2023-08-03

Locations

2 sites across 1 country: Belgium