In Vivo Efficacy of Salbutamol (Sandoz) Versus Salbutamol Ventolin (GSK) in Children With Asthma
Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
In this study, the investigators hypothesize that the reference product (SalbR/Ventolin) is
more effective than SalbG (Salbutamol Sandoz) at improving the lung function in children with
asthma, and that this difference increases alongside the severity of the airway resistance.
(Null hypothesis: There is no difference).
This could be explained by different properties and deposition of the aerosol.
Purpose of this research:
Rejecting the null hypothesis. This is based on the answers to the questions below.
Research questions:
1. Is there a difference between the increase in FEV1 (and FVC) after 100 μg SalbG versus
FEV1 after 100 μg SalbR in children aged 4-14 years with insufficient asthma control?
(primary question)
2. Is there a difference in the subjective feeling of the children after inhalation with
100 μg SalbR and after 100 μg SalbG, measured with a VAS score?
3. Is the increase in FEV1 (and FVC) in children with asthma between 4-14 years of age with
insufficient asthma control after inhalation of 400 μg SalbR different than after
inhalation of 400 μg SalbG?
4. Is there a difference in the subjective feeling of the children after inhalation with
400 μg SalbR and after 400 μg SalbG, measured with a VAS score?