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

NCT04408664 | Terminated Phase 3

• 1 other identifier: s63147
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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).

Conditions

Exercise-Induced Bronchoconstriction

Keywords

Athletes; Sodium Cromoglycate; Cromones; Lomudal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Difference in symptom perception on a scale 0 to 5, with 5 maximum score per symptom

  6 months

• Asthma development

  6 months

• Biomarkers in blood/sputum (optional)

  6 months

Study Arms (2)

Sodium Cromoglycate

EXPERIMENTAL

Patients will take Sodium Cromoglycate (SCG) (Lomudal®) 4 times daily during 6 months: SCG 4X1 ampulla of 2 mL daily (by Omron pocket aerosol).

Drug: Sodium Cromoglycate

Sodium Chloride 0.9%

PLACEBO COMPARATOR

Patients will take Sodium Chloride 0.9% 4 times daily during 6 months: Sodium Chloride 4X1 ampulla of 2 mL daily (by Omron pocket aerosol).

Drug: Placebo

Interventions

Sodium Cromoglycate DRUG

Sodium Cromoglicate 10 mg/mL packed in ampulla of 2 mL; Daily dosis of 4X20 mg milligram delivered by aerosol.

Also known as: DNCG Iso, Lomudal

Sodium Cromoglycate

Placebo DRUG

Sodium Chloride 0.9% packed in ampulla of 2 mL; Daily dosis of 4 ampulla delivered by aerosol.

Also known as: Sodium Chloride

Sodium Chloride 0.9%

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Jessa Hospital: collaborator
• Algemeen Ziekenhuis Maria Middelares: collaborator

Study Sites (2)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Related Publications (3)

• 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.

  PMID: 26790574 BACKGROUND

• 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.

  PMID: 31356920 BACKGROUND

• 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.

  PMID: 20216468 BACKGROUND

MeSH Terms

Interventions

Cromolyn Sodium; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double-blinded clinical trial

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 29, 2020
• Study Start: April 6, 2021
• Primary Completion: June 28, 2023
• Study Completion: August 1, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)