Effect of inhalation formulation on uncontrolled asthma
Phase 1
- Conditions
- AsthmaMedDRA version: 20.0Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-003864-27-FI
- Lead Sponsor
- HUS / Mika Mäkelä
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
age 12-<18 years (male and female)
prior doctor diagnosed asthma with need of regular anti-asthmatic medication for at least 3 months; except Relvar® Ellipta® and Flutiform® K-haler®, and insufficient asthma control
FEV1/FVC reduced (z<-1,65 SD )
signed informed consent
sufficient skills to communicate in Finnish
Are the trial subjects under 18? yes
Number of subjects for this age range: 70
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
Exclusion Criteria
pregnancy
lactation
other pulmonary disease than asthma
active and uncontrolled cardiovascular or other systemic disease
malignancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method