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

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborators: Algemeen Ziekenhuis Maria Middelares; Jessa Hospital
• Treatments: Cromolyn Sodium

Criteria

Inclusion Criteria:

• Diagnosis of exercise-induced-bronchoconstriction (EIB) based on positive EVH-test in WP1 (s59778) or WP2 (s61602)

• BMI between 5th and <85th percentile for age and gender

Exclusion Criteria:

• Clinically diagnosed asthma

• Baseline lung function:

• FEV1%: ≤80% predicted FEV1%

• Tiffeneau: FEV1/FVC% < 85%

• Salbutamol-induced FEV1 reversibility ≥ 12%

• Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol

• Smoker

• Participation in other study related to IMP

• If applicable: female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method