Recruiting NCT06531798

Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease

Phase IV Interventional Moderate to Severe COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Breztri Aerosphere.
Who it may be relevant to: Registry conditions: Moderate to Severe COPD. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: India
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

Drug Breztri Aerosphere
Budesonide 160 mcg/Glycopyrrolate 7.2 mcg/Formoterol fumarate dehydrate 5 mcg

Primary outcome measures

To observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD [Time frame: 24 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

India · 5 centers

Research Site — Dalgate, Drugjan
Research Site — Hyderabad
Research Site — Lucknow
Research Site — Nagpur
Research Site — New Delhi

Identifiers

NCT: NCT06531798 · D5980L00017

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗