N/A
N=101
Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03242759 ↗Enrolled (actual)
101
Serious AEs
30.7%
Results posted
Mar 2021
Primary outcome: Primary: Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52 — -0.5; 4.1 Percentage of predicted FVC — p=0.505
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- nintedanib (Drug); pirfenidone (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52 |
-0.5; 4.1 | 0.505 |
| PRIMARY Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100 |
-0.2; -2.5 | 0.571 |
| PRIMARY Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52 |
-7.3; -2.8 | < 0.001 sig |
| PRIMARY Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100 |
0.5; -2.6 | 0.027 sig |
| PRIMARY Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52 |
-0.8; -0.8 | 0.001 sig |
| PRIMARY Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100 |
-0.2; -0.6 | 0.018 sig |
| PRIMARY Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52 |
-0.4; -1.4 | 0.073 |
| PRIMARY Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100 |
-2.3; -3.4 | < 0.001 sig |
| PRIMARY Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52 |
-6.8; -6.1 | < 0.001 sig |
| PRIMARY Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100 |
-4.5; -6.0 | < 0.001 sig |
| SECONDARY Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis |
497.0; 521.5 | — |
| SECONDARY Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 |
8.4; 0.2 | < 0.001 sig |
| SECONDARY Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 |
2.6; 1.6 | 0.169 |
| SECONDARY Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52 |
1.4; 0.2 | 0.333 |
| SECONDARY Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100 |
0.7; 0.7 | 0.245 |
| SECONDARY Annual Change in Six-Minute Walk Test (6MWT) at Week 52 |
-7.6; 7.1 | 0.543 |
| SECONDARY Annual Change in Six-Minute Walk Test (6MWT) at Week 100 |
-20.7; -2.3 | 0.046 sig |
| SECONDARY Overall Survival |
686.0; 641.0 | — |
| SECONDARY Number of Participants Per Death Reason Categories |
11; 0; 7; 1; 4; 0 | — |
Summary
This is a non-interventional, multi-center study to collect data from patients with idiopathic pulmonary fibrosis (IPF) in clinical practice in Taiwan. The study will be carried out at 10 medical centers, the expert centers where IPF patients are mainly managed in Taiwan.
Eligibility Criteria
Inclusion Criteria
- Patients can be included if ALL the following criteria are met:
1.Newly diagnosed with IPF within 6 months based upon recent ATS/ERS/JRS/ALAT IPF guideline (Ref 1, Raghu G, et al. 2011).
- Exclusion of other known causes of ILD (e.g. domestic and occupational environmental exposures, connective tissue disease, and drug toxicity).
- Assessment of IPF based on HRCT or HRCT and surgical lung biopsy, if available. 2.Patient ≥ 20 years of age 3.Written informed consent prior to participation 4.Patients with further follow-up possible with participating physician during planned study period 5.Ability to read and write in the local language
Exclusion Criteria
- Patients should not be included if ANY of the following criteria is met:
- Lung transplantation expected within next 6 months.
- Inclusion in ongoing clinical trials.
Data sourced from ClinicalTrials.gov (NCT03242759). 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.