A multi-centre study comparing idiopathic pulmonary fibrosis and combined pulmonary fibrosis and emphysema
| ISRCTN | ISRCTN28134901 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28134901 |
| Secondary identifying numbers | CE22228B |
- Submission date
- 18/07/2023
- Registration date
- 13/08/2023
- Last edited
- 05/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Combined pulmonary fibrosis and emphysema (CPFE) and idiopathic pulmonary fibrosis (IPF) are progressive lung diseases with limited treatment options. This study aimed to compare the treatment outcomes of patients with CPFE and those with IPF receiving anti-fibrotic agents.
Who can participate?
Patients with interstitial lung disease (ILD) with IPF or CPFE.
What does the study involve:
The study involved following IPF and CPFE patients for a duration of 3 years and recording their survival outcomes.
What are the possible benefits and risks of participating?
This study will investigate the prognosis of two lung diseases and identify possible underlying risk factors in both. There were no risks of participation as it was not an interventional study.
Where is the study run from?
Taichung Veterans General Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
June 2015 to November 2022
Who is funding the study?
Taichung Veterans General Hospital (Taiwan)
Who is the main contact?
Dr Pin-Kuei Fu, paper199350@gmail.com
Contact information
Principal Investigator
1650 Taiwan Boulevard Sect. 4
Taichung City
407219
Taiwan
 ORCID ID |
0009-0009-1843-4513 |
|---|---|
| Phone | +886 (0)4 2359 2525 |
| paper199350@gmail.com |
Study information
| Study design | Retrospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not applicable |
| Scientific title | Idiopathic pulmonary fibrosis with or without emphysema: a 3-year multi-centre study |
| Study acronym | multiTaiCPFE2022 |
| Study objectives | Patients with combined pulmonary fibrosis and emphysema (CPFE) treated with anti-fibrotic agents had survival outcomes similar to those of patients with idiopathic pulmonary fibrosis (IPF). |
| Ethics approval(s) |
1. Approved 12/05/2022, The Institutional Review Board of Taichung Veterans General Hospital (1650 Taiwan Boulevard Sect. 4, Taichung City, 407219, Taiwan; +886 (0)4 2359 2525; imsc@vghtc.gov.tw), ref: CE22228B 2. Approved 13/07/2022, The Institutional Review Board of National Taiwan University, Yun-Lin Branch (No.579, Sec. 2, Yunlin Rd., Taichung City, 640, Taiwan; +886 (0)5 6330002 #8521; Y03511@ms1.ylh.gov.tw), ref: 202206026RINA 3. Approved 30/04/2022, The Institutional Review Board of China Medical University Hospital (No. 2, Yude Rd., North Dist., Taichung City, 404327, Taiwan; +886 (0)4 2205 2121; imc@mail.cmuh.org.tw), ref: CMUH111-REC2-077 4. Approved 22/06/2022, The Institutional Review Board of Chang Gung Medical Foundation (No.5, Fuxing St., Guishan Dist., Taoyuan City, 333, Taiwan; +886 (0)3 328 1200; syu2323@cgmh.org.tw), ref: 202200850B0 5. Approved 23/08/2022, The Institutional Review Board of Chang Gung Medical Foundation (No.5, Fuxing St., Guishan Dist., Taoyuan City, 333, Taiwan; +886 (0)3 328 1200; syu2323@cgmh.org.tw), ref: 202201260B0 6. Approved 04/07/2022, The Institutional Review Board of E-DA hospital (No.1, Yida Road, Jiaosu Village, Yanchao District, Kaohsiung City, 82445, Taiwan; +886 (0)7 615 0011 #5765; ed111235@edah.org.tw), ref: EMRP-111-079 7. Approved 05/08/2022, The Institutional Review Board of Ministry of Health and Welfare Taoyuan General Hospital (No. 1492, Zhongshan Rd, Taoyuan District, Taoyuan City, 330, Taiwan; +886 (0)3 3699721#3907; IHC@mail.tygh.gov.tw), ref: TYGH111040 8. Approved 18/12/2018, Institutional Review Board of Taichung Veterans General Hospital (1650 Taiwan Boulevard Sect. 4, Taichung City, 407219, Taiwan; +886 (0)4 2359 2525; imsc@vghtc.gov.tw), ref: CE18325B |
| Health condition(s) or problem(s) studied | Patients with interstitial pulmonary fibrosis only (IPF) and patients with combined pulmonary fibrosis and emphysema (CPFE) |
| Intervention | The study involved following IPF and CPFE patients for a duration of 3 years and recording their survival outcomes. |
| Intervention type | Other |
| Primary outcome measure | 3-year survival rate measured using patients' medical records |
| Secondary outcome measures | 1. Pulmonary function measured using spirometer at baseline and every year for 3 years 2. Disease progression measured using Gender-Age-Physiology (GAP) score at baseline and every year for 3 years |
| Overall study start date | 01/06/2015 |
| Completion date | 28/11/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | >250 |
| Total final enrolment | 275 |
| Key inclusion criteria | 1. Patients with a definitive diagnosis of interstitial lung disease by a pulmonologist and confirmed by high-resolution computed tomography (HRCT) 2. Passed the health insurance review to pay for the anti-pulmonary fibrosis medications |
| Key exclusion criteria | 1. Patients not fulfilling the criteria of interstitial lung disease 2. Patients not having health insurance to cover anti-fibrotic medications |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 31/08/2022 |
Locations
Countries of recruitment
- Taiwan
Study participating centres
Taichung City
407219
Taiwan
Douliu City
640
Taiwan
Taichung City
404327
Taiwan
Taoyuan City
333
Taiwan
Kaohsiung City
82445
Taiwan
Taoyuan City
330
Taiwan
Sponsor information
Hospital/treatment centre
1650 Taiwan Boulevard Sect. 4
Taichung
407219
Taiwan
| Phone | +886 (0)4 2359 2525 |
|---|---|
| janniferlee@gmail.com | |
| Website | http://www.vghtc.gov.tw/GipOpenWeb/wSite/mp?mp=8 |
"ROR" |
https://ror.org/00e87hq62 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- 臺中榮民總醫院, TCVGH
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Dr Pin-Kuei Fu (yetquen@gmail.com) |
Editorial Notes
05/09/2023: The sponsor email was changed.
01/08/2023: Study's existence confirmed by the Institutional Review Board of Taichung Veterans General Hospital.
