Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
The incidence of treatment-emergent adverse events (TEAEs) from Day 1 through Week 24.
Detailed description
Change from baseline through 24 weeks in forced vital capacity (FVC) in mL., Change from baseline through 24 weeks in percent predicted forced vital capacity (ppFVC)., Change from baseline at 24 weeks in lung fibrosis measured by high resolution computed tomography (HRCT)., Exploratory Endpoint: Change from baseline through 24 weeks in the Living with Pulmonary Fibrosis (L-PF) questionnaire dyspnea and cough domains., Exploratory Endpoint: Time to all-cause respiratory hospitalization lung transplantation, or death through 28 weeks., Exploratory Endpoint: Change from baseline through 24 weeks for biomarkers related to the pathophysiology of IPF.
Interventions
DRUGThe placebo is InhaLac® 500 (micronized lactose monohyrdate).
DRUGLTI-03
Sponsors
Rein Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of treatment-emergent adverse events (TEAEs) from Day 1 through Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline through 24 weeks in forced vital capacity (FVC) in mL., Change from baseline through 24 weeks in percent predicted forced vital capacity (ppFVC)., Change from baseline at 24 weeks in lung fibrosis measured by high resolution computed tomography (HRCT)., Exploratory Endpoint: Change from baseline through 24 weeks in the Living with Pulmonary Fibrosis (L-PF) questionnaire dyspnea and cough domains., Exploratory Endpoint: Time to all-cause respiratory hospitalization lung transplantation, or death through 28 weeks., Exploratory Endpoint: Change from baseline through 24 weeks for biomarkers related to the pathophysiology of IPF. | — |
Countries
Germany, Poland
Outcome results
None listed