N/A
N=34,960
Study of Progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Incidence/Management and Treatment
Lung Diseases, Interstitial
Bottom Line
View on ClinicalTrials.gov: NCT05875532 ↗Enrolled (actual)
34,960
Serious AEs
—
Results posted
Sep 2024
Primary outcome: Primary: Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs) — 0.147; 0.249; 0.334; 0.395 Cumulative incidence probability
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs) |
0.147; 0.249; 0.334; 0.395 | — |
| SECONDARY Number of Patients With Treatment of Interest During Follow-up Period |
49; 499; 30; 200; 225; 201 | — |
| SECONDARY Number of Patients With Management of Interest During Follow-up Period |
1641; 0; 9520 | — |
Summary
The primary objective for this trial is to investigate the incidence probability of progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in patients with fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in real-world setting in Japan.
The secondary objective is to investigate the characteristics of procedures for management and treatment in patients with fibrosing ILD other than IPF in real-world setting in Japan.
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with at least two fibrosing Interstitial Lung Disease (ILD) codes on different dates in the patient identification period
- Patients aged 18 years and older on the index date
- Patients for whom data for the 12 months prior to the index date can be extracted as baseline data
Exclusion Criteria
- Patients grouped into the underlying disease of Idiopathic Pulmonary Fibrosis (IPF)
- Patients who have met PF-ILD progression criteria during the baseline period
Data sourced from ClinicalTrials.gov (NCT05875532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.