The predictive value of the acute effect of beclomethasone-dipropionate on a mannitol challenge test for the outcome of longterm treatment with beclomethasone-dipropionate in childhood asthma

The predictive value of the acute effect of beclomethasone-dipropionate on a mannitol challenge test for the outcome of longterm treatment with beclomethasone-dipropionate in childhood asthma - Predictive value of single dose ICS study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002276-27-NL

Enrollment

Unknown

Registered

2016-07-20

Start date

2016-08-04

Completion date

Unknown

Last updated

2016-08-16

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

Conditions

exercise induced bronchoconstriction asthma MedDRA version: 19.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Qvar 100 aerosol (beclomethasone-dipropionate) Product Name: Beclomethasone-dipropionate Product Code: R03AK08 Pharmaceutical Form: Inhalation vapour, solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age between 12-18 years - Clinical history of allergic asthma and exercise induced bronchoconstriction - Ability to perform reproducible lung function tests, variation of the predicted value in 3 of 5 consecutive measurements 70% of predicted value Are the trial subjects under 18? yes Number of subjects for this age range: 25 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: - Other pulmonary or cardiac illnesses - Maximal FEV1 < 70% of predicted value - Use of nasal or systemic or inhalation corticosteroids, antihistamines, cromoglycates, anticholinergics or leukotriene antagonists in two weeks prior to or during the study - Use of long acting bronchodilator agents 24 hours before testing - Use of short acting bronchodilator agents 8 hours before testing - Hospitalization due to asthma exacerbation in past month - Other changes in asthma medication during treatment period - Upper or lower respiratory tract infections during treatment period - Deviation of the FEV1 before the subsequent mannitol challenges of more than 12 % from baseline FEV1

Design outcomes

Primary

Measure	Time frame
Main Objective: What is the correlation in mannitol PD15 (provoking dose of mannitol to cause >15% fall in FEV1) 6h after a single dose of beclomethasone and after 4 weeks of treatment with beclomethasone?;Secondary Objective: not applicable;Primary end point(s): correlation between change in mannitol PD15 after a single dose of beclomethasone-dipropionate and after 4 weeks of treatment with beclomethasone-dipropionate;Timepoint(s) of evaluation of this end point: 1 day and 4 weeks	—

Measure

Time frame

Main Objective: What is the correlation in mannitol PD15 (provoking dose of mannitol to cause >15% fall in FEV1) 6h after a single dose of beclomethasone and after 4 weeks of treatment with beclomethasone?;Secondary Objective: not applicable;Primary end point(s): correlation between change in mannitol PD15 after a single dose of beclomethasone-dipropionate and after 4 weeks of treatment with beclomethasone-dipropionate;Timepoint(s) of evaluation of this end point: 1 day and 4 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: na	—

Countries

Netherlands

Contacts

Public ContactBJ Thio

Medisch Spectrum Twente

b.thio@mst.nl

Outcome results

None listed

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