EUCTR2018-001291-38-NL
Active, not recruiting
Phase 1
In vivo efficacy of Salbutamol Sandoz versus salbutamol Ventolin GSK in children with asthma - Salsa
ConditionsAsthma in childrenMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsVentolin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Asthma in children
- Sponsor
- Radboud University Medical Center
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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) \<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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 80
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
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.
Outcomes
Primary Outcomes
Not specified
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