WP3-Influence of cromones on EVH-test in young elite athletes who tested positive for EIB (=exercise induced bronchoconstriction.

WP3-Influence of cromones on EVH-test in young elite athletes who tested positive for EIB.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003606-27-BE

Enrollment

Registered

2020-02-19

Start date

2020-02-19

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise-induced bronchoconstriction (EIB)

Interventions

Trade Name: Lomudal 20 mg Product Name: Sodium Cromoglicate 10 mg/mL Product Code: BE110503 Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: Lomudal Other descriptive name: CROMOGLI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Positive EVH tes in s58778 or s61602 Are the trial subjects under 18? yes Number of subjects for this age range: 75 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Acute inflammatory illness; 18y at inclusion in s59778 or s61602

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the reduction in % max fall of FEV1 on EVH test after 6 months of treatment.;Secondary Objective: To compare the development of exercise-induced asthma (EIA) and symptom scores between the treated and untreated group. ;Primary end point(s): Individual's decrease in % max fall in FEV1 on EVH-test after 6 month treatment compared to baseline.;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: To study the reduction in % max fall of FEV1 on EVH test after 6 months of treatment.;Secondary Objective: To compare the development of exercise-induced asthma (EIA) and symptom scores between the treated and untreated group. ;Primary end point(s): Individual's decrease in % max fall in FEV1 on EVH-test after 6 month treatment compared to baseline.;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): Development of EIA proportion in both groups.;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Belgium

Contacts

Public ContactCTC

UZ Leuven

ctc@uzleuven.be+3216341998

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026