Status:
TERMINATED
Influence of Cromones on Eucapnic Hyperventilation (EVH)-Test in Young (Elite) Athletes Who Tested Positive for EIB.
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Jessa Hospital
Algemeen Ziekenhuis Maria Middelares
Conditions:
Exercise-Induced Bronchoconstriction
Eligibility:
All Genders
11-18 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04408664
Start Date
April 6 2021
End Date
August 1 2023
Last Update
August 3 2023
Active Locations (2)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
2
AZ Maria Middelares
Ghent, Belgium, 9000