Moderate to Severe COPD
Conditions
Brief 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.
Detailed description
Study details include: The study duration will be 26 weeks The treatment duration will be 24 weeks
Interventions
Budesonide 160 mcg/Glycopyrrolate 7.2 mcg/Formoterol fumarate dehydrate 5 mcg
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD | 24 weeks | Percentage, nature, intensity, seriousness and causal relationship of AEs, SAEs, and AEs leading to discontinuation of study drug will be assessed |
Countries
India
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed