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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03242759
• Collaborator: (none)
• Enrollment: 101
• Locations: 10
• Actual Duration (Months): 30.1
• Patients Per Site: 10.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Fibrosis	Drug: nintedanib; Drug: pirfenidone

Study Design

• Study Type: Observational
• Actual Enrollment: 101 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
• Actual Study Start Date: Aug 17, 2017
• Actual Primary Completion Date: Feb 18, 2020
• Actual Study Completion Date: Feb 18, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52 [At baseline and Week 52.]

   Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.

2. Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100 [At baseline and Week 100.]

   Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.

3. Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52 [At baseline and Week 52.]

   Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported

4. Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100 [At baseline and Week 100.]

   Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.

5. Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52 [At baseline and Week 52.]

   Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.

6. Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100 [At baseline and Week 100.]

   Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.

7. Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52 [At baseline and Week 52.]

   Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.

8. Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100 [At baseline and Week 100.]

   Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.

9. Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52 [At baseline and Week 52.]

   Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.

10. Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100 [At baseline and Week 100.]

    Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.

Secondary Outcome Measures

1. Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis [From baseline until end of follow-up, up to 899 days.]

   Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.

2. Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 [At baseline and 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.

3. Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 [At baseline and 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.

4. Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52 [At baseline and 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.

5. Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100 [At baseline and 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.

6. Annual Change in Six-Minute Walk Test (6MWT) at Week 52 [At baseline and 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.

7. Annual Change in Six-Minute Walk Test (6MWT) at Week 100 [At baseline and 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.

8. Overall Survival [From baseline until end of follow-up, up to 899 days.]

   Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause.

9. Number of Participants Per Death Reason Categories [From baseline until end of follow-up, up to 899 days.]

   Number of participants per death reason categories was reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang-Hua Christian Hospital	Changhua		Taiwan	500
2	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan	807
3	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	83301
4	Far Eastern Memorial Hospital	New Taipei		Taiwan	220
5	China Medical University Hospital	Taichung		Taiwan	404
6	Taichung Veterans General Hospital	Taichung		Taiwan	40705
7	National Taiwan University Hospital	Taipei		Taiwan	10048
8	Taipei Veterans General Hospital	Taipei		Taiwan	11217
9	Tri-Service General Hospital	Taipei		Taiwan	114
10	Chang Gung Memorial Hospital(Linkou)	Tao-Yuan		Taiwan	333

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Apr 10, 2017
• Statistical Analysis Plan - Apr 21, 2020

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03242759
• Other Study ID Numbers: 1199-0303
• First Posted: Aug 8, 2017
• Last Update Posted: Apr 13, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Fibrosis; Pirfenidone; Nintedanib

Study Results

Participant Flow

Recruitment Details	This was a non-interventional multi-center study based on newly collected data on idiopathic pulmonary fibrosis (IPF) patients in clinical practice in Taiwan with a planned 2-year followed-up period to characterize the IPF population in Taiwan with regard to their clinical course under clinical practice conditions in Taiwan.
Pre-assignment Detail	All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Period Title: Overall Study
STARTED	88	13
COMPLETED	53	6
NOT COMPLETED	35	7

Baseline Characteristics

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug	Total
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.	Total of all reporting groups
Overall Participants	88	13	101
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	74.7 (8.97)	74.1 (10.64)	74.6 (9.14)
Sex: Female, Male (Count of Participants)
Female	17 19.3%	0 0%	17 16.8%
Male	71 80.7%	13 100%	84 83.2%
Race/Ethnicity, Customized (Count of Participants)
Oriental	88 100%	13 100%	101 100%
Percent predicted Forced Vital Capacity (FVC) of lung function (Percentage of predicted FVC) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of predicted FVC]	69.7 (14.06)	97.8 (10.97)	73.3 (16.64)
Percent predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) of lung function (Percentage of perdicted DLco) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of perdicted DLco]	42.7 (19.74)	57.5 (17.96)	45.2 (20.11)
Percent predicted oxygen saturation (SpO2) (Percentage of predicted SpO2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of predicted SpO2]	95.5 (2.31)	97.5 (1.69)	95.8 (2.33)
Percent predicted Total Lung Capacity (TLC) (Percentage of perdicted TLC) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of perdicted TLC]	74.3 (13.25)	100.2 (13.04)	77.2 (15.50)
Percent predicted Inspiratory Capacity (IC) (Percentage of perdicted IC) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of perdicted IC]	62.8 (15.62)	87.5 (21.49)	65.6 (17.87)

Outcome Measures

1. Primary Outcome

Title	Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52
Description	Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.
Time Frame	At baseline and Week 52.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Percentage of predicted FVC]	-0.5 (10.78)	4.1 (7.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.505
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.181
	Comments
	Method	Paired t-test
	Comments

2. Primary Outcome

Title	Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100
Description	Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.
Time Frame	At baseline and Week 100.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Percentage of predicted FVC]	-0.2 (7.74)	-2.5 (4.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.571
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.232
	Comments
	Method	Paired t-test
	Comments

3. Primary Outcome

Title	Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52
Description	Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported
Time Frame	At baseline and Week 52.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Percentage of predicted DLco]	-7.3 (10.47)	-2.8 (8.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.375
	Comments
	Method	Paired t-test
	Comments

4. Primary Outcome

Title	Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100
Description	Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.
Time Frame	At baseline and Week 100.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Percentage of predicted DLco]	0.5 (6.83)	-2.6 (6.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.938
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Primary Outcome

Title	Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52
Description	Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.
Time Frame	At baseline and Week 52.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Percentage of predicted SpO2]	-0.8 (2.22)	-0.8 (0.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.048
	Comments
	Method	Paired t-test
	Comments

6. Primary Outcome

Title	Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100
Description	Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.
Time Frame	At baseline and Week 100.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Percentage of predicted SpO2]	-0.2 (0.96)	-0.6 (0.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.125
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Primary Outcome

Title	Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52
Description	Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.
Time Frame	At baseline and Week 52.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Percentage of predicted TLC]	-0.4 (9.97)	-1.4 (12.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.073
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.755
	Comments
	Method	Paired t-test
	Comments

8. Primary Outcome

Title	Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100
Description	Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.
Time Frame	At baseline and Week 100.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Percentage of predicted TLC]	-2.3 (3.76)	-3.4 (6.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.281
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Primary Outcome

Title	Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52
Description	Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.
Time Frame	At baseline and Week 52.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Percentage of predicted IC]	-6.8 (10.18)	-6.1 (1.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

10. Primary Outcome

Title	Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100
Description	Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.
Time Frame	At baseline and Week 100.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Percentage of predicted IC]	-4.5 (5.00)	-6.0 (2.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.031
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

11. Secondary Outcome

Title	Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Description	Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.
Time Frame	From baseline until end of follow-up, up to 899 days.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Median (Full Range) [Days]	497.0	521.5

12. Secondary Outcome

Title	Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52
Description	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.
Time Frame	At baseline and Week 52.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Score on a scale]	8.4 (16.52)	0.2 (8.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.939
	Comments
	Method	Paired t-test
	Comments

13. Secondary Outcome

Title	Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100
Description	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.
Time Frame	At baseline and Week 100.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Score on a scale]	2.6 (13.36)	1.6 (6.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.169
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.545
	Comments
	Method	Paired t-test
	Comments

14. Secondary Outcome

Title	Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52
Description	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.
Time Frame	At baseline and Week 52

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Score on a scale]	1.4 (7.80)	0.2 (1.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.333
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.786
	Comments
	Method	Paired t-test
	Comments

15. Secondary Outcome

Title	Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100
Description	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.
Time Frame	At baseline and Week 100

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Score on a scale]	0.7 (4.37)	0.7 (2.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.245
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.454
	Comments
	Method	Paired t-test
	Comments

16. Secondary Outcome

Title	Annual Change in Six-Minute Walk Test (6MWT) at Week 52
Description	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.
Time Frame	At baseline and Week 52.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Meter]	-7.6 (60.42)	7.1 (31.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.543
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.733
	Comments
	Method	Paired t-test
	Comments

17. Secondary Outcome

Title	Annual Change in Six-Minute Walk Test (6MWT) at Week 100
Description	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.
Time Frame	At baseline and Week 100.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Mean (Standard Deviation) [Meter]	-20.7 (36.60)	-2.3 (20.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.046
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Comments	Intra-group difference comparing to baseline was analyzed.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.898
	Comments
	Method	Paired t-test
	Comments

18. Secondary Outcome

Title	Overall Survival
Description	Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause.
Time Frame	From baseline until end of follow-up, up to 899 days.

Outcome Measure Data

Analysis Population Description

All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	88	13
Median (Full Range) [Days]	686.0	641.0

19. Secondary Outcome

Title	Number of Participants Per Death Reason Categories
Description	Number of participants per death reason categories was reported.
Time Frame	From baseline until end of follow-up, up to 899 days.

Outcome Measure Data

Analysis Population Description

All eligible patients who died during the study. All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.

Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug	Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
Measure Participants	28	1
Related to idiopathic pulmonary fibrosis	11 12.5%	0 0%
Related to comorbidity	7 8%	1 7.7%
Other	4 4.5%	0 0%
Unknown	6 6.8%	0 0%

Adverse Events

Time Frame	From baseline until end of follow-up, up to 899 days.
Adverse Event Reporting Description	All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Arm/Group Title	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug		Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Arm/Group Description	Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.		Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.
All Cause Mortality
	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug		Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/88 (31.8%)		1/13 (7.7%)
Serious Adverse Events
	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug		Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/88 (33%)		2/13 (15.4%)
Blood and lymphatic system disorders
Anaemia of chronic disease	1/88 (1.1%)		0/13 (0%)
Cardiac disorders
Acute myocardial infarction	0/88 (0%)		1/13 (7.7%)
Atrioventricular block complete	1/88 (1.1%)		0/13 (0%)
Bradycardia	1/88 (1.1%)		0/13 (0%)
Cardiac arrest	1/88 (1.1%)		1/13 (7.7%)
Myocardial infarction	1/88 (1.1%)		0/13 (0%)
General disorders
Death	10/88 (11.4%)		0/13 (0%)
Pyrexia	1/88 (1.1%)		0/13 (0%)
Hepatobiliary disorders
Hepatitis	1/88 (1.1%)		0/13 (0%)
Infections and infestations
Bacteraemia	1/88 (1.1%)		0/13 (0%)
Oral candidiasis	1/88 (1.1%)		0/13 (0%)
Pneumonia	9/88 (10.2%)		0/13 (0%)
Sepsis	1/88 (1.1%)		0/13 (0%)
Septic shock	1/88 (1.1%)		0/13 (0%)
Urinary tract infection	1/88 (1.1%)		0/13 (0%)
Injury, poisoning and procedural complications
Fall	1/88 (1.1%)		0/13 (0%)
Investigations
Alanine aminotransferase abnormal	1/88 (1.1%)		0/13 (0%)
Aspartate aminotransferase abnormal	1/88 (1.1%)		0/13 (0%)
Nervous system disorders
Intraventricular haemorrhage	1/88 (1.1%)		0/13 (0%)
Renal and urinary disorders
Acute kidney injury	1/88 (1.1%)		0/13 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/88 (1.1%)		0/13 (0%)
Dyspnoea	1/88 (1.1%)		0/13 (0%)
Idiopathic pulmonary fibrosis	6/88 (6.8%)		0/13 (0%)
Pneumonia aspiration	1/88 (1.1%)		0/13 (0%)
Respiratory failure	3/88 (3.4%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug		Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/88 (40.9%)		2/13 (15.4%)
Gastrointestinal disorders
Diarrhoea	29/88 (33%)		0/13 (0%)
Investigations
Alanine aminotransferase abnormal	10/88 (11.4%)		1/13 (7.7%)
Aspartate aminotransferase abnormal	8/88 (9.1%)		0/13 (0%)
Metabolism and nutrition disorders
Decreased appetite	6/88 (6.8%)		0/13 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary mass	0/88 (0%)		1/13 (7.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.