Efficacy of two bronchodilators in children with asthma

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001291-38-NL

Enrollment

Registered

2018-06-04

Start date

2018-08-08

Completion date

Unknown

Last updated

2024-01-08

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

Conditions

Asthma in children MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Ventolin Product Name: Salbutamol Pharmaceutical Form: Inhalation vapour, emulsion INN or Proposed INN: salbutamol Sandoz Other descriptive name: SALBUTAMOL MICRONIZED Concentration unit:

Eligibility

Sex/Gender

All

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. van ouders bij kinderen tot 12 jaar, en informed consent van ouders en assent van kinderen bij de leeftijd van 12-14 jaar - 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) =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Severe acute asthma for which high and frequent dosages of Salbutamol are needed - Inability to conduct a lung function test well - 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

Measure	Time frame
Main Objective: The hypothesis of this study is that reference product SalbR is more effective than SalbG in improving lung function in children with asthma and diminished asthma control, and that this difference is larger in children with more airways resistance. The Null hypothesis is that there is no difference The primary objective of the study is to reject the Null Hypothesis This will be determined by the answers on the following questions: Research questions: 1.Is there a difference between the increase of Forced Expiratory Volume in 1 second (FEV1) following inhalation of 100 ug SalbG versus FEV1 following 100 ug SalbR in children with reduced asthma control ;Secondary Objective: secondary aims of the study are: 2.Is there a difference in the subjective feeling of children after inhalation of 100 ug SalbR versus after 100 ug SalbG, using a visual analogue scale? 3.Is the increase of FEV1 in children with asthma after inhalation of in total 400 ug SalbR higher than after inhalation of in total 400 ug SalbG? 4.Is there a difference in subjective feeling of the children after inhalation of 400 ug SalbR versus after 400 ug SalbG, using a visual analogue scale?;Primary end point(s): Forced Expiratory in 1 second before and after inhalation of 100 ug salbutamol (SalbR - Ventolin- or SalbG - Salbutamol Sandoz) with a spacer. Primary endpoint of study: Differences in FEV1 follwing the first dose of 100 ug, expressed as SDS/Z-scores or in % of the predicted value [1] between SalbR and SalbG. Based on the literature [2] a sample size calculation was conducted. With the SD FEV1 of 8% of predicted value, a difference of 5% can be detected when 2x3 childen participate (Beta = 80% and alfa = 5%). Assuming a drop out rate of 10%, the aim of the study is to include 2x 40 children with asthma. Through the design of the study, we can compare the effect of dosages of 100 ug in 2 groups of 40 children, can we compare the effects of the second dose of 300 ug in 2 groups	—

Measure

Time frame

Main Objective: The hypothesis of this study is that reference product SalbR is more effective than SalbG in improving lung function in children with asthma and diminished asthma control, and that this difference is larger in children with more airways resistance. The Null hypothesis is that there is no difference The primary objective of the study is to reject the Null Hypothesis This will be determined by the answers on the following questions: Research questions: 1.Is there a difference between the increase of Forced Expiratory Volume in 1 second (FEV1) following inhalation of 100 ug SalbG versus FEV1 following 100 ug SalbR in children with reduced asthma control ;Secondary Objective: secondary aims of the study are: 2.Is there a difference in the subjective feeling of children after inhalation of 100 ug SalbR versus after 100 ug SalbG, using a visual analogue scale? 3.Is the increase of FEV1 in children with asthma after inhalation of in total 400 ug SalbR higher than after inhalation of in total 400 ug SalbG? 4.Is there a difference in subjective feeling of the children after inhalation of 400 ug SalbR versus after 400 ug SalbG, using a visual analogue scale?;Primary end point(s): Forced Expiratory in 1 second before and after inhalation of 100 ug salbutamol (SalbR - Ventolin- or SalbG - Salbutamol Sandoz) with a spacer. Primary endpoint of study: Differences in FEV1 follwing the first dose of 100 ug, expressed as SDS/Z-scores or in % of the predicted value [1] between SalbR and SalbG. Based on the literature [2] a sample size calculation was conducted. With the SD FEV1 of 8% of predicted value, a difference of 5% can be detected when 2x3 childen participate (Beta = 80% and alfa = 5%). Assuming a drop out rate of 10%, the aim of the study is to include 2x 40 children with asthma. Through the design of the study, we can compare the effect of dosages of 100 ug in 2 groups of 40 children, can we compare the effects of the second dose of 300 ug in 2 groups

—

Secondary

Measure	Time frame
Secondary end point(s): FEV1 before and after inhalation of the second dose of salbutamol (300 ug), VAS scores for dyspnea, and short questionnaire after end of study. This implies 3 times lung function testing instead of twice (twice being usual care);Timepoint(s) of evaluation of this end point: T=0: first VAS scoring T=15: 2nd VAS scoring T=35: FEV1 measurement 15 minuten after the 2nd dose of salbutamol, T=35: 3rd VAS scoring T=40 short questionnaire: 1) does the first puff taste differently than the first? 2) which one doe you prefer? (first, second, donot know) 3) is the first more effective or is the second more effective? 4) Does one of them taste as you have at home?	—

Measure

Time frame

Secondary end point(s): FEV1 before and after inhalation of the second dose of salbutamol (300 ug), VAS scores for dyspnea, and short questionnaire after end of study. This implies 3 times lung function testing instead of twice (twice being usual care);Timepoint(s) of evaluation of this end point: T=0: first VAS scoring T=15: 2nd VAS scoring T=35: FEV1 measurement 15 minuten after the 2nd dose of salbutamol, T=35: 3rd VAS scoring T=40 short questionnaire: 1) does the first puff taste differently than the first? 2) which one doe you prefer? (first, second, donot know) 3) is the first more effective or is the second more effective? 4) Does one of them taste as you have at home?

—

Countries

Netherlands

Contacts

Public ContactPeter Merkus

Radboud University Medical Center

peter.merkus@radboudumc.nl+31243614430

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026