In Vivo Efficacy of Salbutamol (Sandoz) Versus Salbutamol Ventolin (GSK) in Children With Asthma

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canisius-Wilhelmina Hospital
• Treatments: Albuterol

Criteria

Inclusion Criteria:

• Informed consent both parents in case of children aged < 12 years, informed consent both parents and patient of children aged 12-14 years

• Patients classified as doctor's diagnosed asthma, preferably with confirmed bronchial hyperreactivity or reversibility (FEV1 > 9% predicted) in earlier lung function assessment and/or known efficacy of salbutamol as rescue medication (either subjective or clinically)

• Indication for lung function assessment as part of regular medical care

• A score of < 20 on the C-ACT (children astma control questionnaire, 4-11 years) or ACT (12-16 years) and/or FEV1 <10% when compared to personal's best and/or FEV1 < 80% predicted and/or actual subjective impression of dyspnea in such severity that patient or caretaker would normally have used their bronchusdilatator

Exclusion Criteria:

• Status asthmaticus with a need for (continuous) nebulisation of salbutamol

• Inability of performing a technically adequate and reliable lung function assessment

• Inability of adequate instruction of patient and/or caretakers due to difficulty in communication and/or language barrier

• Clinically relevant comorbidities with impact on the lung function assessment (eg (cardio)pulmonary disease, muscle disease etc)