Current Status of Diagnosis, Treatment and Quality of Life for Patients with Idiopathic Pulmonary Fibrosis

NCT ID: NCT06629623

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-30

Study Completion Date

2025-12-30

Brief Summary

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The goal of this observational study is to explore current status of diagnosis, treatment and quality of life for patients with idiopathic pulmonary fibrosis. It aims to integrate qualitative and quantitative data to describe the distribution of perspective, experience, patient journey, treatment, expectation and quality of life for patients with idiopathic pulmonary fibrosis.

Participants will be invited to participate the interview, and answer quantitative survey questions about their quality of life.

Detailed Description

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Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, fibrotic interstitial lung disease of unknown aetiology primarily affecting middle-aged and elderly patients, more men than women. Median survival is 3∼5 years from the time of diagnosis. The prognosis is worse than for most common malignancies. However, patients' experiences, quality of life and needs during the disease course, have not been adequately investigated, which leads a lack of evidence to support the priority of treatment or drug development.

This study plans to conduct an mixed methods research to integrate qualitative and quantitative data to explore the perspective, experience, patient journey, treatment, expectation and quality of life for patients with idiopathic pulmonary fibrosis. For qualitative interview, there are 50 patients with idiopathic pulmonary fibrosis, and 15 physicians will be interviewed. For quantitative survey, there are 245 patients with idiopathic pulmonary fibrosis will be involved.

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with IPF

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* IPF patients who are diagnosed according to international guidelines.
* Physicians who are clinical experts with extensive experience in the treatment of IPF.

Exclusion Criteria

\- The patient is unable to express his/her opinion clearly.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Zhejiang Chinese Medical University

OTHER_GOV

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role collaborator

Chu Hongling

OTHER

Sponsor Role lead

Responsible Party

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Chu Hongling

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hongling Chu, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Kreuter M, Swigris J, Pittrow D, Geier S, Klotsche J, Prasse A, Wirtz H, Koschel D, Andreas S, Claussen M, Grohe C, Wilkens H, Hagmeyer L, Skowasch D, Meyer JF, Kirschner J, Glaser S, Herth FJF, Welte T, Neurohr C, Schwaiblmair M, Held M, Bahmer T, Frankenberger M, Behr J. Health related quality of life in patients with idiopathic pulmonary fibrosis in clinical practice: insights-IPF registry. Respir Res. 2017 Jul 14;18(1):139. doi: 10.1186/s12931-017-0621-y.

Reference Type BACKGROUND
PMID: 28709421 (View on PubMed)

Chu H, Ding Y, Zhou Y, Ji P, Yuan B, Zhan X, Lu X, Liu N, Zhang Y, Yan B, Fang X, Xu X, Huang Z, Li W, Shen N, Zhan S. Patient journey and Quality of Life for Patients with Idiopathic Pulmonary Fibrosis (IPFLife) in China: a sequential exploratory mixed methods research protocol. BMJ Open. 2025 Aug 12;15(8):e098770. doi: 10.1136/bmjopen-2025-098770.

Reference Type DERIVED
PMID: 40803740 (View on PubMed)

Other Identifiers

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M2024203

Identifier Type: -

Identifier Source: org_study_id

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