Pulmonary FibrosisUPWARDNCT07722507
Antifibrotic Therapy Decision-Making in Pulmonary Fibrosis
An observational study of Pulmonary Fibrosis and Idiopathic Pulmonary Fibrosis, run by Bristol-Myers Squibb at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
- What is being tested?
- Antifibrotic therapy
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- 1 Aug 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participants must meet all the following criteria to be eligible for inclusion in this study:
- 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).
Show all 13Show fewer
- 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
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
About this study
Official title: 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.
- Being tested
- Antifibrotic therapy
- Keywords
- Antifibrotic therapy, Pulmonary fibrosis (PF), Idiopathic pulmonary fibrosis (IPF), Progressive pulmonary fibrosis (PPF)
- Medical subject headings
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antifibrotic therapyDrug
Also called Antifibrotic therapies include pirfenidone, nintedanib or nerandomilast.
As per product label prescribed by treating physician
| Study group | Role | What they receive |
|---|---|---|
| Continuation group | Participants who have continued at least one antifibrotic therapy for a specific period (≥6 months) at the time of enrollment. Receives: Drug: Antifibrotic therapy | |
| Discontinuation group | Participants who have completely ceased all antifibrotic therapies for at least 1 month prior to enrollment. Receives: Drug: Antifibrotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722507
- Sponsor's protocol ID
- IM027-1062
- Acronym
- UPWARD
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Pulmonary Fibrosis Through Web-Based Qualitative In-Depth Interviews on Antifibrotic TheRapy Decision-Making
- ClinicalTrials.gov ID
- NCT07722507
- Acronym / sponsor ID
- UPWARD / IM027-1062
- Keywords
- Antifibrotic therapy, Pulmonary fibrosis (PF), Idiopathic pulmonary fibrosis (IPF), Progressive pulmonary fibrosis (PPF)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuation group | – | Drug: Antifibrotic therapyParticipants who have continued at least one antifibrotic therapy for a specific period (≥6 months) at the time of enrollment. |
| Discontinuation group | – | Drug: Antifibrotic therapyParticipants who have completely ceased all antifibrotic therapies for at least 1 month prior to enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- Participants must meet all the following criteria to be eligible for inclusion in this study:
- 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.
Key exclusion criteria (5 listed)
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- Discontinuation group only 1) Participants who discontinued AF therapy solely for reasons other than AE (e.g., financial reasons, disease progression).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antifibrotic therapyAlso: Antifibrotic therapies include pirfenidone, nintedanib or nerandomilast.As per product label prescribed by treating physician | Drug | Continuation group, Discontinuation group |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis and Idiopathic Pulmonary Fibrosis, run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.