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New study checks safety of triple therapy inhaler for COPD patients

NCT ID NCT06531798

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 21, 2026 · Updated 5 times

Summary

This study is monitoring the safety and tolerability of Breztri Aerosphere, a triple-combination inhaler, in 150 Indian patients with moderate to severe COPD. Participants will use the inhaler as maintenance treatment while researchers track side effects. The goal is to ensure the drug is safe for long-term use in this population.

What this could mean

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

Active substance
Breztri Aerosphere (budesonide, glycopyrronium, formoterol)
What this could lead to
If successful, this study will confirm that Breztri Aerosphere is safe and well-tolerated for long-term use in managing moderate to severe COPD.
What could go wrong
This is an observational safety study, not designed to prove new benefits. Side effects like pneumonia or allergic reactions are possible, and results may not apply to all populations.

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 150 people

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

Started

Jan 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: Patients with a physician-confirmed diagnosis of COPD * With a history of one severe COPD exacerbation or two or more moderate COPD exacerbations in the preceding 12 months. * Post-bronchodilator FEV1 should be between ≥30 % to \<80% of the predicted normal. * Both male and female patients are allowed in the study * Female of Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal) * A urine pregnancy test must be negative at screening. * female participant must follow effective contraceptive method as outlined in protocol * Patients should be capable of giving signed informed consent Exclusion Criteria: * Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study. * Chest x-ray within 6 months before screening must be acceptable to the investigator. Subjects who have a chest x-ray that reveals clinically significant abnormalities not believed to be due to the presence of COPD should not be included. A chest x-ray must be conducted if the most recent chest x-ray is not available at the time of screening. * Patients having moderate to severe exacerbations within 6 weeks before the Screening period. * Female patients who are pregnant or lactating or planning a family during the study period. * Patients with either a history of hypersensitivity to excipients of the study drug or drugs with a similar chemical structure or class to the study drug. * Patients participating in any current or future interventional trial during the study will not be enrolled in the current study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Dalgate, Drugjan, 190001, India

  • Research Site

    RECRUITING

    Hyderabad, 500084, India

  • Research Site

    RECRUITING

    Lucknow, 226010, India

  • Research Site

    RECRUITING

    Nagpur, 440010, India

  • Research Site

    RECRUITING

    New Delhi, 110029, India