New study checks safety of triple therapy inhaler for COPD patients
NCT ID NCT06531798
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Moderate to severe COPD are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
5 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGDalgate, Drugjan, 190001, India
-
Research Site
RECRUITINGHyderabad, 500084, India
-
Research Site
RECRUITINGLucknow, 226010, India
-
Research Site
RECRUITINGNagpur, 440010, India
-
Research Site
RECRUITINGNew Delhi, 110029, India