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Tests treatment safety and results for Moderate to Severe COPD
Official title Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT06531798
What this study is testing
What is Breztri Aerosphere?
Breztri Aerosphere is an investigational medicine, being studied as a potential treatment for moderate to severe copd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation...
- Chest x-ray within 6 months before screening must be acceptable to the investigator. people who have a chest x-ray that reveals clinically...
- 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...
- Patients participating in any current or future treatment trial during the study will not be enrolled in the current study.
See the full eligibility 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
- 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...
- Chest x-ray within 6 months before screening must be acceptable to the investigator. people who have a chest x-ray that reveals clinically significant abnormalities not believed to be due to the presence of COPD should...
- 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 treatment trial during the study will not be enrolled in the current study.
The study team makes the final eligibility decision.
Where it's taking place
- Hyderabad, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hyderabad, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.