N/A Completed N=101

Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT03242759 ↗

Enrolled (actual)

101

Serious AEs

30.7%

Results posted

Mar 2021

Primary outcomePrimary: 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

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.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.