Moderate to Severe COPDPhase 4INDOS-BNCT06531798
Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Breztri Aerosphere in people with Moderate to Severe COPD, run by AstraZeneca at 6 sites in India.
Trial summary
The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe COPD
- What is being tested?
- Breztri Aerosphere
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 6 sitesIndia
- Study dates
- 20 Jan 2026to 30 Dec 2027
- Phase
- Phase 4
- 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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
6 sites in 1 country
India6 sites, 6 recruiting
- Not yet recruiting
Research Site
Bangalore, 560017
- Recruiting
Research Site
Dalgate, Drugjan, 190001
- Recruiting
Research Site
Hyderabad, 500084
- Recruiting
Research Site
Lucknow, 226010
- Recruiting
Research Site
Nagpur, 440010
- Recruiting
Research Site
New Delhi, 110029
About this study
Official title: Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.
Read the detailed description
Study details include:
The study duration will be 26 weeks The treatment duration will be 24 weeks
- Conditions
- Moderate to Severe COPD
- Being tested
- Breztri Aerosphere
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breztri AerosphereDrug
Budesonide 160 mcg/Glycopyrrolate 7.2 mcg/Formoterol fumarate dehydrate 5 mcg
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | It will be a single-arm interventional phase 4 clinical study where participants will receive treatment with Breztri aerosphereTM containing budesonide 160 mcg/ glycopyrronium 7.2 mcg/ formoterol fumarate dehydrate 5 mcg (Breztri aerosphereTM pMDI) two actuations twice daily through oral inhalation for 24 weeks. Receives: Drug: Breztri Aerosphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD
Percentage, nature, intensity, seriousness and causal relationship of AEs, SAEs, and AEs leading to discontinuation of study drug will be assessed
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start20 Jan 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe COPDStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531798
- Sponsor's protocol ID
- D5980L00017
- Acronym
- INDOS-B
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06531798
- Acronym / sponsor ID
- INDOS-B / D5980L00017
- Conditions
- Moderate to Severe COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 1 Aug 2024 (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.
The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.
Detailed description
Study details include:
The study duration will be 26 weeks The treatment duration will be 24 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Breztri AerosphereIt will be a single-arm interventional phase 4 clinical study where participants will receive treatment with Breztri aerosphereTM containing budesonide 160 mcg/ glycopyrronium 7.2 mcg/ formoterol fumarate dehydrate 5 mcg (Breztri aerosphereTM pMDI) two actuations twice daily through oral inhalation for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Breztri AerosphereBudesonide 160 mcg/Glycopyrrolate 7.2 mcg/Formoterol fumarate dehydrate 5 mcg | Drug | Single arm |
Primary outcome
To observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD
Time frame: 24 weeks
Percentage, nature, intensity, seriousness and causal relationship of AEs, SAEs, and AEs leading to discontinuation of study drug will be assessed
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 2 Oct 2026.
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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.
AstraZeneca Clinical Study Information Center contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Breztri Aerosphere in people with Moderate to Severe COPD, run by AstraZeneca at 6 sites in India.
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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD (time frame: 24 weeks). 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 2 Oct 2026.