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

Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242759
• Other study ID #: 1199-0303
• Status: Completed
• Start date: August 17, 2017
• Est. completion date: February 18, 2020

Study information

• Verified date: March 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 18, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Fibrosis

Intervention

Drug:
• nintedanib
Drug
• pirfenidone
Drug

Locations

Country	Name	City	State
Taiwan	Chang-Hua Christian Hospital	Changhua
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital(Linkou)	Tao-Yuan

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

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