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

August 1, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • AZ Maria Middelares
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium Cromoglycate
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 Cromoglicate 10 mg/mL packed in ampulla of 2 mL; Daily dosis of 4X20 mg milligram delivered by aerosol.
Other Names:
  • DNCG Iso
  • Lomudal
Placebo Comparator: Sodium Chloride 0.9%
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
Sodium Chloride 0.9% packed in ampulla of 2 mL; Daily dosis of 4 ampulla delivered by aerosol.
Other Names:
  • Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percentage maximal fall of FEV1 after EVH-test compared to baseline maximal fall
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in symptom perception on a scale 0 to 5, with 5 maximum score per symptom
Time Frame: 6 months
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
Asthma development
Time Frame: 6 months
Asthma development will be assessed by the occurrence of a positive reversibility test during the trial and compared between both arms.
6 months
Biomarkers in blood/sputum (optional)
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Jessa Hospital
Algemeen Ziekenhuis Maria Middelares

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Actual)

June 28, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s63147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data will be analysed and grouped before release

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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