NL-OMON52633
Recruiting
Not Applicable
In vivo efficacy of Salbutamol Sandoz versus salbutamol Ventolin GSK in children with asthma - Salsa Study
Canisius Wilhelmina Ziekenhuis0 sites80 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Canisius Wilhelmina Ziekenhuis
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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., \- 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
Exclusion Criteria
- •\- Severe Asthmatic attack for which high doses of Salbutamol are needed, \-
- •Inability to conduct a lung function test reliably, \- Inability to read or
- •understand the Dutch Language, \- Concomitant other chronic physical or mental
- •condition that precludes conducting a reliable lung function test.
Outcomes
Primary Outcomes
Not specified
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