Pulmonary Fibrosis
Conditions
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.
Interventions
DRUGnintedanib
Drug
DRUGpirfenidone
Drug
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Taiwan
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 88 |
| 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. | 13 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative problems | 1 | 1 |
| Overall Study | Adverse Event | 5 | 1 |
| Overall Study | Change visit schedule | 0 | 1 |
| Overall Study | Death | 22 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Total |
|---|---|---|---|
| Age, Continuous | 74.7 Years STANDARD_DEVIATION 8.97 | 74.1 Years STANDARD_DEVIATION 10.64 | 74.6 Years STANDARD_DEVIATION 9.14 |
| Percent predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) of lung function | 42.7 Percentage of perdicted DLco STANDARD_DEVIATION 19.74 | 57.5 Percentage of perdicted DLco STANDARD_DEVIATION 17.96 | 45.2 Percentage of perdicted DLco STANDARD_DEVIATION 20.11 |
| Percent predicted Forced Vital Capacity (FVC) of lung function | 69.7 Percentage of predicted FVC STANDARD_DEVIATION 14.06 | 97.8 Percentage of predicted FVC STANDARD_DEVIATION 10.97 | 73.3 Percentage of predicted FVC STANDARD_DEVIATION 16.64 |
| Percent predicted Inspiratory Capacity (IC) | 62.8 Percentage of perdicted IC STANDARD_DEVIATION 15.62 | 87.5 Percentage of perdicted IC STANDARD_DEVIATION 21.49 | 65.6 Percentage of perdicted IC STANDARD_DEVIATION 17.87 |
| Percent predicted oxygen saturation (SpO2) | 95.5 Percentage of predicted SpO2 STANDARD_DEVIATION 2.31 | 97.5 Percentage of predicted SpO2 STANDARD_DEVIATION 1.69 | 95.8 Percentage of predicted SpO2 STANDARD_DEVIATION 2.33 |
| Percent predicted Total Lung Capacity (TLC) | 74.3 Percentage of perdicted TLC STANDARD_DEVIATION 13.25 | 100.2 Percentage of perdicted TLC STANDARD_DEVIATION 13.04 | 77.2 Percentage of perdicted TLC STANDARD_DEVIATION 15.5 |
| Race/Ethnicity, Customized Oriental | 88 Participants | 13 Participants | 101 Participants |
| Sex: Female, Male Female | 17 Participants | 0 Participants | 17 Participants |
| Sex: Female, Male Male | 71 Participants | 13 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 28 / 88 | 1 / 13 |
| other Total, other adverse events | 36 / 88 | 2 / 13 |
| serious Total, serious adverse events | 29 / 88 | 2 / 13 |
Outcome results
Primary
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 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 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100 | -2.6 Percentage of predicted DLco | Standard Deviation 6.26 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.027Wilcoxon (Mann-Whitney)
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.938Wilcoxon (Mann-Whitney)
Primary
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 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 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52 | -2.8 Percentage of predicted DLco | Standard Deviation 8.27 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.375Paired t-test
Primary
Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 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 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100 | -2.5 Percentage of predicted FVC | Standard Deviation 4.52 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.571Wilcoxon (Mann-Whitney)
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.232Paired t-test
Primary
Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 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 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52 | 4.1 Percentage of predicted FVC | Standard Deviation 7.73 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.505Wilcoxon (Mann-Whitney)
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.181Paired t-test
Primary
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100 | -4.5 Percentage of predicted IC | Standard Deviation 5 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100 | -6.0 Percentage of predicted IC | Standard Deviation 2.4 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.031Wilcoxon (Mann-Whitney)
Primary
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52 | -6.8 Percentage of predicted IC | Standard Deviation 10.18 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52 | -6.1 Percentage of predicted IC | Standard Deviation 1.73 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.008Wilcoxon (Mann-Whitney)
Primary
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100 | -0.2 Percentage of predicted SpO2 | Standard Deviation 0.96 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100 | -0.6 Percentage of predicted SpO2 | Standard Deviation 0.84 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.018Wilcoxon (Mann-Whitney)
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.125Wilcoxon (Mann-Whitney)
Primary
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52 | -0.8 Percentage of predicted SpO2 | Standard Deviation 2.22 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52 | -0.8 Percentage of predicted SpO2 | Standard Deviation 0.92 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.001Wilcoxon (Mann-Whitney)
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.048Paired t-test
Primary
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 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 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100 | -3.4 Percentage of predicted TLC | Standard Deviation 6.89 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.281Wilcoxon (Mann-Whitney)
Primary
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 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 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52 | -1.4 Percentage of predicted TLC | Standard Deviation 12.18 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.073Wilcoxon (Mann-Whitney)
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.755Paired t-test
Secondary
Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100
The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 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 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100 | 0.7 Score on a scale | Standard Deviation 2.13 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.245Paired t-test
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.454Paired t-test
Secondary
Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52
The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52 | 1.4 Score on a scale | Standard Deviation 7.8 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52 | 0.2 Score on a scale | Standard Deviation 1.96 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.333Wilcoxon (Mann-Whitney)
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.786Paired t-test
Secondary
Annual Change in Six-Minute Walk Test (6MWT) at Week 100
Annual change in Six-Minute Walk Test (6MWT) at Week 100 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Annual Change in Six-Minute Walk Test (6MWT) at Week 100 | -20.7 Meter | Standard Deviation 36.6 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change in Six-Minute Walk Test (6MWT) at Week 100 | -2.3 Meter | Standard Deviation 20.51 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.046Paired t-test
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.898Paired t-test
Secondary
Annual Change in Six-Minute Walk Test (6MWT) at Week 52
Annual change in Six-Minute Walk Test (6MWT) at Week 52 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Annual Change in Six-Minute Walk Test (6MWT) at Week 52 | -7.6 Meter | Standard Deviation 60.42 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change in Six-Minute Walk Test (6MWT) at Week 52 | 7.1 Meter | Standard Deviation 31.53 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.543Paired t-test
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.733Paired t-test
Secondary
Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 | 2.6 Score on a scale | Standard Deviation 13.36 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 | 1.6 Score on a scale | Standard Deviation 6.17 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.169Paired t-test
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.545Paired t-test
Secondary
Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 was reported.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 | 8.4 Score on a scale | Standard Deviation 16.52 |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 | 0.2 Score on a scale | Standard Deviation 8.12 |
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: <0.001Paired t-test
Comparison: Intra-group difference comparing to baseline was analyzed.p-value: 0.939Paired t-test
Secondary
Number of Participants Per Death Reason Categories
Number of participants per death reason categories was reported.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Number of Participants Per Death Reason Categories | Related to idiopathic pulmonary fibrosis | 11 Participants |
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Number of Participants Per Death Reason Categories | Related to comorbidity | 7 Participants |
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Number of Participants Per Death Reason Categories | Other | 4 Participants |
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Number of Participants Per Death Reason Categories | Unknown | 6 Participants |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Number of Participants Per Death Reason Categories | Unknown | 0 Participants |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Number of Participants Per Death Reason Categories | Related to idiopathic pulmonary fibrosis | 0 Participants |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Number of Participants Per Death Reason Categories | Other | 0 Participants |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Number of Participants Per Death Reason Categories | Related to comorbidity | 1 Participants |
Secondary
Overall Survival
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.
Population: All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Overall Survival | 686.0 Days |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Overall Survival | 641.0 Days |
Secondary
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis | 497.0 Days |
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis | 521.5 Days |