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

Exercise-Induced Bronchoconstriction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04408664
• Other study ID #: s63147
• Status: Terminated
• Phase: Phase 3
• Start date: April 6, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 1, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise-Induced Bronchoconstriction

Intervention

Drug:
• Sodium Cromoglycate
Sodium Cromoglicate 10 mg/mL packed in ampulla of 2 mL; Daily dosis of 4X20 mg milligram delivered by aerosol.
• Placebo
Sodium Chloride 0.9% packed in ampulla of 2 mL; Daily dosis of 4 ampulla delivered by aerosol.

Locations

Country	Name	City	State
Belgium	AZ Maria Middelares	Ghent
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Algemeen Ziekenhuis Maria Middelares, Jessa Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Jonckheere AC, Seys S, Dilissen E, Schelpe AS, Van der Eycken S, Corthout S, Verhalle T, Goossens J, Vanbelle V, Aertgeerts S, Troosters T, Peers K, Dupont L, Bullens D. Early-onset airway damage in early-career elite athletes: A risk factor for exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2019 Nov;144(5):1423-1425.e9. doi: 10.1016/j.jaci.2019.07.014. Epub 2019 Jul 26. No abstract available. — View Citation

Kippelen P, Larsson J, Anderson SD, Brannan JD, Dahlen B, Dahlen SE. Effect of sodium cromoglycate on mast cell mediators during hyperpnea in athletes. Med Sci Sports Exerc. 2010 Oct;42(10):1853-60. doi: 10.1249/MSS.0b013e3181da4f7d. — View Citation

Van der Eycken S, Schelpe A, Marijsse G, Dilissen E, Troosters T, Vanbelle V, Aertgeerts S, Dupont LJ, Peers K, Bullens DM, Seys SF. Feasibility to apply eucapnic voluntary hyperventilation in young elite athletes. Respir Med. 2016 Feb;111:91-3. doi: 10.1016/j.rmed.2015.12.012. Epub 2016 Jan 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percentage maximal fall of FEV1 after EVH-test compared to baseline maximal fall	Individual's paired change in percentage maximal fall of FEV1 in relation to EVH-test between baseline values and values after 6 month treatment with sodium cromoglycate or placebo.	6 months
Secondary	Difference in symptom perception on a scale 0 to 5, with 5 maximum score per symptom	Symptom perception will be assessed by a questionnaire (scale: no, very mild, little, moderate, serious, very serious) . Comparison will be done per individual and between both arms.	6 months
Secondary	Asthma development	Asthma development will be assessed by the occurrence of a positive reversibility test during the trial and compared between both arms.	6 months
Secondary	Biomarkers in blood/sputum (optional)	Change in expression of inflammatory markers and markers of epithelial damage after 6 months of treatment in blood and sputum (e.g. CC16, uric acid, IL1-B, ...)	6 months