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

NCT ID: NCT03242759

Last Updated: 2021-04-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-17

Study Completion Date

2020-02-18

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with idiopathic pulmonary fibrosis (IPF)

nintedanib

Intervention Type DRUG

Drug

pirfenidone

Intervention Type DRUG

Drug

Interventions

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nintedanib

Drug

Intervention Type DRUG

pirfenidone

Drug

Intervention Type DRUG

Other Intervention Names

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OVEF

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang-Hua Christian Hospital

Changhua, , Taiwan

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Far Eastern Memorial Hospital

New Taipei City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Chang Gung Memorial Hospital(Linkou)

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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1199-0303

Identifier Type: -

Identifier Source: org_study_id

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