A Phase 3 interventional study of Sodium Cromoglycate and Placebo in Exercise-Induced Bronchoconstriction, sponsored by Universitaire Ziekenhuizen KU Leuven. Terminated at 2 sites in Belgium. Open to participants aged 11 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 3, Interventional, and Treatment
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).
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.
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Baseline lung function:
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
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 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 Chloride 0.9% packed in ampulla of 2 mL; Daily dosis of 4 ampulla delivered by aerosol.
Also known as: Sodium Chloride
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.
Time frame: 6 months
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.
Time frame: 6 months
Asthma development
Asthma development will be assessed by the occurrence of a positive reversibility test during the trial and compared between both arms.
Time frame: 6 months
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, ...)
Time frame: 6 months
Plan to share: No — data will be analysed and grouped before release
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven