Antifibrotic Therapy Decision-Making in Pulmonary Fibrosis (UPWARD)

Understanding Pulmonary Fibrosis Through Web-Based Qualitative In-Depth Interviews on Antifibrotic TheRapy Decision-Making

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Progressive Pulmonary Fibrosis
• Intervention / Treatment: Drug: Antifibrotic therapy

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Japan
  • Tokyo, Japan
    • Mebix, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

Participants must meet all the following criteria to be eligible for inclusion in this study:

1. Pulmonary fibrosis (PF) participants in Japan. Note: This includes those clinically recognized as having idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).
2. Participants who are ≥18 years of age at the time of providing informed consent via the web-based system.
3. Participants receiving outpatient care for pulmonary fibrosis (PF) who have been introduced to this study by a referring physician.
4. Participants who have a history of taking, or are currently taking, pirfenidone, nintedanib, or nerandomilast.

5. Participants who have experienced at least one antifibrotic (AF) therapy-related adverse event (AE).

   • Discontinuation group only

1) Participants who have not received AF therapy for at least 1 month prior to enrollment.

2) Participants whose AF therapy was discontinued within 6 months prior to enrollment.

3) Participants whose reason for discontinuing AF therapy includes at least one AF therapy-related AE.

• Continuation group only

  1. Participants who feel or have felt burdened by the experienced AE.

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

     Exclusion Criteria:

     Participants meeting any of the following criteria will be excluded from the study:

  1. Participants currently participating in any interventional clinical trials (regardless of the study drug, excluding observational studies).
  2. 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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; As per product label prescribed by treating physician; Other Names: Antifibrotic therapies include pirfenidone, nintedanib or nerandomilast.
Discontinuation group; Participants who have completely ceased all antifibrotic therapies for at least 1 month prior to enrollment.	Drug: Antifibrotic therapy; As per product label prescribed by treating physician; Other Names: Antifibrotic therapies include pirfenidone, nintedanib or nerandomilast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Idiopathic pulmonary fibrosis (IPF); Antifibrotic therapy; Pulmonary fibrosis (PF); Progressive pulmonary fibrosis (PPF)
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; nintedanib
• Other Study ID Numbers: IM027-1062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes