Antifibrotic Therapy Decision-Making in Pulmonary Fibrosis

ConditionsPulmonary Fibrosis Idiopathic Pulmonary Fibrosis Progressive Pulmonary Fibrosis

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Antifibrotic therapy
Drug
As per product label prescribed by treating physician

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Continuation group1 intervention

Group B: Discontinuation group1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Day 1

Secondary outcomes

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

Time frame

Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: