Asthma in Children Clinical Trial
— SalsaOfficial title:
In Vivo Efficacy of Salbutamol (Sandoz) Versus Salbutamol Ventolin (GSK) in Children With Asthma
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?
Status | Recruiting |
Enrollment | 80 |
Est. completion date | September 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 14 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Canisius Wilhelmina Hospital | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Canisius-Wilhelmina Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Age | Age (years) | baseline | |
Other | Length | Length (cms) | baseline | |
Other | Weight | Weight (kgs) | baseline | |
Other | Gender | Gender (F/M) | baseline | |
Other | Allergies | Any known allergies | baseline | |
Other | Inhalation corticosteroids (ICs) | Use of inhalation corticosteroids (Yes/No) | baseline | |
Primary | FEV1 (%) 100ug salbutamol | FEV1 (%) after inhalation of 100 microgram salbutamol | baseline | |
Secondary | VAS 100ug salbutamol | VAS score after inhalation of 100 microgram salbutamol | baseline | |
Secondary | FEV1 (%) 400ug salbutamol | FEV1 (%) after inhalation of 400 microgram salbutamol | baseline | |
Secondary | VAS 400ug salbutamol | VAS score after inhalation of 400 microgram salbutamol | baseline |
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