In vivo efficacy of Salbutamol Sandoz versus salbutamol Ventolin GSK in children with asthma

Recruiting

Conditions: Asthma
10006436

Registration Number: NL-OMON52633

Lead Sponsor: Canisius Wilhelmina Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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., - 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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- FEV1 after the inhalation of 100 micrograms salbutamol</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- VAS score after inhalation of 100 micrograms salbutamol<br /><br>- FEV1 after inhalation of 400 micrograms salbutamol<br /><br>- VAS score after inhalation of 400 micrograms salbutamol</p><br>