Antifibrotic Therapy Decision-Making in Pulmonary Fibrosis

NCT07722507 | Not Yet Recruiting FDA Drug

• 1 other identifier: IM027-1062
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore how adults in Japan with pulmonary fibrosis decide whether to continue or discontinue antifibrotic therapy after experiencing antifibrotic therapy-related adverse events.

Conditions

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Progressive Pulmonary Fibrosis

Keywords

Antifibrotic therapy; Pulmonary fibrosis (PF); Idiopathic pulmonary fibrosis (IPF); Progressive pulmonary fibrosis (PPF)

Outcome Measures

Primary Outcomes (1)

• Participant reported decision-making process for antifibrotic therapy persistence or discontinuation when considering the impact of tolerability and adverse events collected via semi-structured qualitative participant interviews

  Day 1

Secondary Outcomes (1)

• Participant reported psychological and clinical processes of perceiving/managing adverse event-related burdens, and factors influencing the will to continue therapy collected via semi-structured qualitative participant interviews

  Day 1

Study Arms (2)

Continuation group

Participants who have continued at least one antifibrotic therapy for a specific period (≥6 months) at the time of enrollment.

Drug: Antifibrotic therapy

Discontinuation group

Participants who have completely ceased all antifibrotic therapies for at least 1 month prior to enrollment.

Drug: Antifibrotic therapy

Interventions

Antifibrotic therapy DRUG

As per product label prescribed by treating physician

Also known as: Antifibrotic therapies include pirfenidone, nintedanib or nerandomilast.

Continuation group; Discontinuation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adults diagnosed with pulmonary fibrosis (PF) in Japan who have a history of taking, or are currently taking, pirfenidone, nintedanib, or nerandomilast treatment who have experienced treatment related adverse events.

You may qualify if:

• Pulmonary fibrosis (PF) participants in Japan. Note: This includes those clinically recognized as having idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).
• Participants who are ≥18 years of age at the time of providing informed consent via the web-based system.
• Participants receiving outpatient care for pulmonary fibrosis (PF) who have been introduced to this study by a referring physician.
• Participants who have a history of taking, or are currently taking, pirfenidone, nintedanib, or nerandomilast.
• Participants who have experienced at least one antifibrotic (AF) therapy-related adverse event (AE).
• Discontinuation group only
• \) Participants who have not received AF therapy for at least 1 month prior to enrollment.
• \) Participants whose AF therapy was discontinued within 6 months prior to enrollment.
• \) Participants whose reason for discontinuing AF therapy includes at least one AF therapy-related AE.
• Continuation group only
• Participants who feel or have felt burdened by the experienced AE.
• Participants who have continued AF therapy for a specific period (≥6 months) at the time of enrollment.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study:
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• Participants currently participating in any interventional clinical trials (regardless of the study drug, excluding observational studies).
• Participants who have undergone lung transplantation.
• Discontinuation group only 1) Participants who discontinued AF therapy solely for reasons other than AE (e.g., financial reasons, disease progression).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Mebix, Inc.

Tokyo, Japan

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)