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New combo therapy aims to slow lung scarring in hypersensitivity pneumonitis

NCT ID NCT05626387

Disease control Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 4 trial tests whether adding mycophenolate mofetil (MMF) to standard prednisolone treatment works better than prednisolone alone for fibrotic hypersensitivity pneumonitis, a lung condition where scarring makes breathing hard. About 144 adults with at least 40% predicted lung function will be randomly assigned to one of the two groups. The main goal is to see how fast lung function declines over one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mycophenolate mofetil (MMF) plus prednisolone
What this could lead to
If it works, this could provide a more effective and safer treatment option for people with fibrotic hypersensitivity pneumonitis, potentially slowing lung function decline.
What could go wrong
This is a relatively small, single-center trial. The combination therapy may not prove more effective than prednisolone alone, and immunosuppressants carry risks like infection and bone marrow suppression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: i. A diagnosis of fibrotic hypersensitivity pneumonitis according to the criteria proposed in the American Thoracic Society Guideline 2020 ii. Screening FVC at least 40% of the predicted value iii. Able to provide a written, informed consent for participation in the trial Exclusion Criteria: i. Baseline FVC \<40% predicted ii. Leucopenia (white blood cell count \<4·0 × 10\^9 per L), significant thrombocytopenia (platelet count \<100 × 10\^9 per L), or clinically significant anemia (hemoglobin \<10 g/dL) iii. Baseline liver transaminases (alanine aminotransferase and aspartate aminotransferase) or bilirubin more than 1·5 times the upper normal limit (except in the case of Gilbert's syndrome) iv. Serum creatinine higher than 2.0 mg/dL v. Uncontrolled congestive heart failure vi. Receipt of prednisolone (more than or equal to 10 mg/day, or equivalent), in the 4 weeks before randomization vii. Prior use of prednisolone (more than or equal to 10 mg/day, or equivalent), MMF, azathioprine, cyclophosphamide, cyclosporine or any other non-glucocorticoid immunosuppressant drug, or antifibrotic agents for more than 12 weeks in the previous year viii. Active infection (lung or elsewhere) whose management would be compromised by MMF or prednisolone ix. Other serious concomitant medical illness (eg, cancer), chronic debilitating illness (other than chronic HP), or drug abuse x. Pregnancy (documented by urine pregnancy test) or breastfeeding xi. Unwilling to participate in the study

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Conditions

The condition(s) this trial relates to.

fibrotic hypersensitivity pneumonitis hypersensitivity pneumonitis interstitial lung disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypersensitivity pneumonitis

Contacts and locations

Locations

  • AIIMS, Jodhpur

    Jodhpur, India

  • AIIMS, New Delhi

    New Delhi, India

  • AIIMS, Rishikesh

    Rishikesh, India

  • CMC Vellore

    Vellore, India

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, Chandigarh, 160012, India

  • Rajasthan Hospital Jaipur

    Jaipur, India

  • Safdarjung Hospital Delhi

    New Delhi, India

  • Sanjay Gandhi Postgraduate Institute

    Lucknow, India

  • Yashoda Hospitals Hyderabad

    Hyderabad, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.