NCT03242759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

August 17, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 8, 2021

Completed
Last Updated

April 13, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

August 3, 2017

Results QC Date

February 15, 2021

Last Update Submit

March 19, 2021

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (10)

  • Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52

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

    At baseline and Week 52.

  • Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100

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

    At baseline and Week 100.

  • Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52

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

    At baseline and Week 52.

  • Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100

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

    At baseline and Week 100.

  • Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52

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

    At baseline and Week 52.

  • Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100

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

    At baseline and Week 100.

  • Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52

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

    At baseline and Week 52.

  • Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100

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

    At baseline and Week 100.

  • Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52

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

    At baseline and Week 52.

  • Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100

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

    At baseline and Week 100.

Secondary Outcomes (9)

  • Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis

    From baseline until end of follow-up, up to 899 days.

  • Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52

    At baseline and Week 52.

  • Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100

    At baseline and Week 100.

  • Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52

    At baseline and Week 52

  • Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100

    At baseline and Week 100

  • +4 more secondary outcomes

Study Arms (1)

patients with idiopathic pulmonary fibrosis (IPF)

Drug: nintedanibDrug: pirfenidone

Interventions

nintedanibDRUG

Drug

Also known as: OVEF
patients with idiopathic pulmonary fibrosis (IPF)
pirfenidoneDRUG

Drug

patients with idiopathic pulmonary fibrosis (IPF)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will be carried out at 10 medical centers, the expert centers where idiopathic pulmonary fibrosis (IPF) patients are mainly managed in Taiwan.

You may qualify if:

  • Patients can be included if ALL the following criteria are met:
  • Newly diagnosed with IPF within 6 months based upon recent ATS/ERS/JRS/ALAT IPF guideline (Ref 1, Raghu G, et al. 2011).
  • 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

You may not qualify if:

  • Patients should not be included if ANY of the following criteria is met:
  • Lung transplantation expected within next 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Chang-Hua Christian Hospital

Changhua, 500, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Chang Gung Memorial Hospital(Linkou)

Taoyuan District, 333, Taiwan

Location

Related Links

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

nintedanibpirfenidone

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 8, 2017

Study Start

August 17, 2017

Primary Completion

February 18, 2020

Study Completion

February 18, 2020

Last Updated

April 13, 2021

Results First Posted

March 8, 2021

Record last verified: 2021-03

Locations

TW(10)