Trial Outcomes & Findings for Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan (NCT NCT03242759)
NCT ID: NCT03242759
Last Updated: 2021-04-13
Results Overview
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.
Recruitment status
COMPLETED
Target enrollment
101 participants
Primary outcome timeframe
At baseline and Week 52.
Results posted on
2021-04-13
Participant Flow
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.
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.
Participant milestones
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
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.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
13
|
|
Overall Study
COMPLETED
|
53
|
6
|
|
Overall Study
NOT COMPLETED
|
35
|
7
|
Reasons for withdrawal
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Administrative problems
|
1
|
1
|
|
Overall Study
Death
|
22
|
0
|
|
Overall Study
Change visit schedule
|
0
|
1
|
Baseline Characteristics
Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
Baseline characteristics by cohort
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.7 Years
STANDARD_DEVIATION 8.97 • n=113 Participants
|
74.1 Years
STANDARD_DEVIATION 10.64 • n=163 Participants
|
74.6 Years
STANDARD_DEVIATION 9.14 • n=160 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
17 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=113 Participants
|
13 Participants
n=163 Participants
|
84 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
88 Participants
n=113 Participants
|
13 Participants
n=163 Participants
|
101 Participants
n=160 Participants
|
|
Percent predicted Forced Vital Capacity (FVC) of lung function
|
69.7 Percentage of predicted FVC
STANDARD_DEVIATION 14.06 • n=113 Participants
|
97.8 Percentage of predicted FVC
STANDARD_DEVIATION 10.97 • n=163 Participants
|
73.3 Percentage of predicted FVC
STANDARD_DEVIATION 16.64 • n=160 Participants
|
|
Percent predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) of lung function
|
42.7 Percentage of perdicted DLco
STANDARD_DEVIATION 19.74 • n=113 Participants
|
57.5 Percentage of perdicted DLco
STANDARD_DEVIATION 17.96 • n=163 Participants
|
45.2 Percentage of perdicted DLco
STANDARD_DEVIATION 20.11 • n=160 Participants
|
|
Percent predicted oxygen saturation (SpO2)
|
95.5 Percentage of predicted SpO2
STANDARD_DEVIATION 2.31 • n=113 Participants
|
97.5 Percentage of predicted SpO2
STANDARD_DEVIATION 1.69 • n=163 Participants
|
95.8 Percentage of predicted SpO2
STANDARD_DEVIATION 2.33 • n=160 Participants
|
|
Percent predicted Total Lung Capacity (TLC)
|
74.3 Percentage of perdicted TLC
STANDARD_DEVIATION 13.25 • n=113 Participants
|
100.2 Percentage of perdicted TLC
STANDARD_DEVIATION 13.04 • n=163 Participants
|
77.2 Percentage of perdicted TLC
STANDARD_DEVIATION 15.50 • n=160 Participants
|
|
Percent predicted Inspiratory Capacity (IC)
|
62.8 Percentage of perdicted IC
STANDARD_DEVIATION 15.62 • n=113 Participants
|
87.5 Percentage of perdicted IC
STANDARD_DEVIATION 21.49 • n=163 Participants
|
65.6 Percentage of perdicted IC
STANDARD_DEVIATION 17.87 • n=160 Participants
|
PRIMARY outcome
Timeframe: At baseline and Week 52.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52
|
-0.5 Percentage of predicted FVC
Standard Deviation 10.78
|
4.1 Percentage of predicted FVC
Standard Deviation 7.73
|
PRIMARY outcome
Timeframe: At baseline and Week 100.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100
|
-0.2 Percentage of predicted FVC
Standard Deviation 7.74
|
-2.5 Percentage of predicted FVC
Standard Deviation 4.52
|
PRIMARY outcome
Timeframe: At baseline and Week 52.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52
|
-7.3 Percentage of predicted DLco
Standard Deviation 10.47
|
-2.8 Percentage of predicted DLco
Standard Deviation 8.27
|
PRIMARY outcome
Timeframe: At baseline and Week 100.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100
|
0.5 Percentage of predicted DLco
Standard Deviation 6.83
|
-2.6 Percentage of predicted DLco
Standard Deviation 6.26
|
PRIMARY outcome
Timeframe: At baseline and Week 52.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52
|
-0.8 Percentage of predicted SpO2
Standard Deviation 2.22
|
-0.8 Percentage of predicted SpO2
Standard Deviation 0.92
|
PRIMARY outcome
Timeframe: At baseline and Week 100.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100
|
-0.2 Percentage of predicted SpO2
Standard Deviation 0.96
|
-0.6 Percentage of predicted SpO2
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: At baseline and Week 52.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52
|
-0.4 Percentage of predicted TLC
Standard Deviation 9.97
|
-1.4 Percentage of predicted TLC
Standard Deviation 12.18
|
PRIMARY outcome
Timeframe: At baseline and Week 100.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100
|
-2.3 Percentage of predicted TLC
Standard Deviation 3.76
|
-3.4 Percentage of predicted TLC
Standard Deviation 6.89
|
PRIMARY outcome
Timeframe: At baseline and Week 52.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52
|
-6.8 Percentage of predicted IC
Standard Deviation 10.18
|
-6.1 Percentage of predicted IC
Standard Deviation 1.73
|
PRIMARY outcome
Timeframe: At baseline and Week 100.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100
|
-4.5 Percentage of predicted IC
Standard Deviation 5.00
|
-6.0 Percentage of predicted IC
Standard Deviation 2.40
|
SECONDARY outcome
Timeframe: From baseline until end of follow-up, up to 899 days.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
|
497.0 Days
Interval 6.0 to 751.0
|
521.5 Days
Interval 111.0 to 721.0
|
SECONDARY outcome
Timeframe: At baseline and Week 52.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52
|
8.4 Score on a scale
Standard Deviation 16.52
|
0.2 Score on a scale
Standard Deviation 8.12
|
SECONDARY outcome
Timeframe: At baseline and Week 100.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100
|
2.6 Score on a scale
Standard Deviation 13.36
|
1.6 Score on a scale
Standard Deviation 6.17
|
SECONDARY outcome
Timeframe: At baseline and Week 52Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52
|
1.4 Score on a scale
Standard Deviation 7.80
|
0.2 Score on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: At baseline and Week 100Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100
|
0.7 Score on a scale
Standard Deviation 4.37
|
0.7 Score on a scale
Standard Deviation 2.13
|
SECONDARY outcome
Timeframe: At baseline and Week 52.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change in Six-Minute Walk Test (6MWT) at Week 52
|
-7.6 Meter
Standard Deviation 60.42
|
7.1 Meter
Standard Deviation 31.53
|
SECONDARY outcome
Timeframe: At baseline and Week 100.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Annual Change in Six-Minute Walk Test (6MWT) at Week 100
|
-20.7 Meter
Standard Deviation 36.60
|
-2.3 Meter
Standard Deviation 20.51
|
SECONDARY outcome
Timeframe: From baseline until end of follow-up, up to 899 days.Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 Participants
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.
|
|---|---|---|
|
Overall Survival
|
686.0 Days
Interval 14.0 to 899.0
|
641.0 Days
Interval 111.0 to 721.0
|
SECONDARY outcome
Timeframe: From baseline until end of follow-up, up to 899 days.Population: 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.
Number of participants per death reason categories was reported.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=28 Participants
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=1 Participants
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.
|
|---|---|---|
|
Number of Participants Per Death Reason Categories
Related to comorbidity
|
7 Participants
|
1 Participants
|
|
Number of Participants Per Death Reason Categories
Other
|
4 Participants
|
0 Participants
|
|
Number of Participants Per Death Reason Categories
Unknown
|
6 Participants
|
0 Participants
|
|
Number of Participants Per Death Reason Categories
Related to idiopathic pulmonary fibrosis
|
11 Participants
|
0 Participants
|
Adverse Events
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
Serious events: 29 serious events
Other events: 36 other events
Deaths: 28 deaths
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 participants at risk
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
7.7%
1/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Cardiac disorders
Atrioventricular block complete
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
7.7%
1/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
General disorders
Death
|
11.4%
10/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
General disorders
Pyrexia
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Hepatobiliary disorders
Hepatitis
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Infections and infestations
Bacteraemia
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Infections and infestations
Oral candidiasis
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Infections and infestations
Pneumonia
|
10.2%
9/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Infections and infestations
Sepsis
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Infections and infestations
Septic shock
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Investigations
Alanine aminotransferase abnormal
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Investigations
Aspartate aminotransferase abnormal
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
6.8%
6/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.1%
1/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.4%
3/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
Other adverse events
| Measure |
Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug
n=88 participants at risk
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.
|
Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug
n=13 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
33.0%
29/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Investigations
Alanine aminotransferase abnormal
|
11.4%
10/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
7.7%
1/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Investigations
Aspartate aminotransferase abnormal
|
9.1%
8/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.8%
6/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
0.00%
0/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/88 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
7.7%
1/13 • From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER