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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52633
Enrollment
80
Registered
2021-10-14
Start date
2023-03-30
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

None listed

Sponsors

Canisius Wilhelmina Ziekenhuis
Lead Sponsor

Eligibility

Age
2 Years to 15 Years

Inclusion criteria

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
- FEV1 after the inhalation of 100 micrograms salbutamol

Secondary

MeasureTime frame
- VAS score after inhalation of 100 micrograms salbutamol - FEV1 after inhalation of 400 micrograms salbutamol - VAS score after inhalation of 400 micrograms salbutamol

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)