Efficacy of two bronchodilators in children with asthma

Phase 1

• Conditions: Asthma in children; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-001291-38-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-04
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- Informed consent of the parents of children up to 12 yrs of age, and informed consent from parents/caretakers of children and of the children aged 12-14 years. van ouders bij kinderen tot 12 jaar, en informed consent van ouders en assent van kinderen bij de leeftijd van 12-14 jaar
- Children known with doctor’s diagnosed asthma, and a history, or physical examanation, or documented positive response on bronchodilators following lung function testing, indicating reversibility of airways obstruction
- C-ACT (children astma controle test questionnaire 4-11 yrs) or ACT(12-16 yrs) <20 and/or FEV1 decline of at least 15% compared to personal's best and/or FEV1 < 80 % of predicted value and/or such symptoms that the parents or the physician would administer a bronchodilator

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
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 0

Exclusion Criteria

- Severe acute asthma for which high and frequent dosages of Salbutamol are needed
- Inability to conduct a lung function test well
- Inability to read or understand the Dutch Language
- Concomitant other chronic physical or mental condition that precludes conducting a reliable lung function test.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified