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

NCT05884970 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-06-01

No results posted yet for this study

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?

Conditions

  • Agents, Anti Asthmatic
  • Asthma in Children

Interventions

DRUG

"100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Sandoz"

Efficacy of Salbutamol Sandoz will be compared to Salbutamol Ventolin GSK (reference)

DRUG

"100 mcg Salbutamol Sandoz" and "300 mcg Salbutamol Ventolin GSK"

Efficacy of Salbutamol Sandoz will be compared to Salbutamol Ventolin GSK (reference)

DRUG

"100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Sandoz"

Efficacy of Salbutamol Sandoz will be compared to Salbutamol Ventolin GSK (reference)

DRUG

"100 mcg Salbutamol Ventolin GSK" and "300 mcg Salbutamol Ventolin GSK"

Efficacy of Salbutamol Sandoz will be compared to Salbutamol Ventolin GSK (reference)

Sponsors & Collaborators

  • Canisius-Wilhelmina Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2024-03-31
Completion
2024-09-30
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05884970 on ClinicalTrials.gov