Study of efficacy and safety of various treatments in participants with idiopathic pulmonary fibrosis (IPF)
- Conditions
- Idiopathic pulmonary fibrosisMedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-005066-17-PL
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 94
-Male and female participants at least 40 years of age
-IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines
-FVC =45% predicted
-DLCO, corrected for hemoglobin, =25% predicted (inclusive)
-Unlikely to undergo lung transplantation during this trial in the opinion of the investigator
-If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization
Additional protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 47
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47
-Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening
-Emphysema >20% on screening HRCT
-Fibrosis <10% on screening HRCT
-Clinical diagnosis of any connective tissue disease
-Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization
Additional protocol-defined exclusion criteria may apply.
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