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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Fibrosis
• Intervention / Treatment: Drug: nintedanib; Drug: pirfenidone

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• Taiwan
  • Changhua, Taiwan, 500
    • Chang-Hua Christian Hospital
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • New Taipei, Taiwan, 220
    • Far Eastern Memorial Hospital
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital
  • Tao-Yuan, Taiwan, 333
    • Chang Gung Memorial Hospital(Linkou)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will be carried out at 10 medical centers, the expert centers where idiopathic pulmonary fibrosis (IPF) patients are mainly managed in Taiwan.

Description

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:

  1. Lung transplantation expected within next 6 months.
  2. Inclusion in ongoing clinical trials.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with idiopathic pulmonary fibrosis (IPF)	Drug: nintedanib; Drug; Other Names: OVEF; Drug: pirfenidone; Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52	Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.	At baseline and Week 52.
Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100	Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.	At baseline and Week 100.
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52	Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported	At baseline and Week 52.
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100	Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.	At baseline and Week 100.
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52	Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.	At baseline and Week 52.
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100	Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.	At baseline and Week 100.
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52	Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.	At baseline and Week 52.
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100	Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.	At baseline and Week 100.
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52	Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.	At baseline and Week 52.
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100	Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.	At baseline and Week 100.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis	Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.	From baseline until end of follow-up, up to 899 days.
Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52	The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 was reported.	At baseline and Week 52.
Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100	The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 was reported.	At baseline and Week 100.
Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52	The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.	At baseline and Week 52
Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100	The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.	At baseline and Week 100
Annual Change in Six-Minute Walk Test (6MWT) at Week 52	Annual change in Six-Minute Walk Test (6MWT) at Week 52 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.	At baseline and Week 52.
Annual Change in Six-Minute Walk Test (6MWT) at Week 100	Annual change in Six-Minute Walk Test (6MWT) at Week 100 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.	At baseline and Week 100.
Overall Survival	Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause.	From baseline until end of follow-up, up to 899 days.
Number of Participants Per Death Reason Categories	Number of participants per death reason categories was reported.	From baseline until end of follow-up, up to 899 days.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2017
• Primary Completion (Actual): February 18, 2020
• Study Completion (Actual): February 18, 2020

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Fibrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Protein Kinase Inhibitors; Pirfenidone; Nintedanib
• Other Study ID Numbers: 1199-0303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No