Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Breztri aerosphere : Breztri aerosphere (Budesonide 160 mcg / Glycopyrronium 7.2 mcg / Formoterol fumarate dihydrate 5 mcg), Fixed-dose triple combination inhalation pMDI
Control Inter
Sponsors
AstraZeneca Pharma India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Patients with a physician-confirmed diagnosis of COPD a. With a history of one severe COPD exacerbation or two or more moderate COPD exacerbations in the preceding 12 months (Please refer to 0 for the definition of COPD exacerbation.) b. Post-bronchodilator FEV1 should be between greater than or equal to 30% to less than 80% predicted Sex and Contraceptive/Barrier Requirements Both adult male and female patients in the age group 18 years and above are allowed in the study. a) Male participants: must agree to use adequate contraception (male condom with spermicide; sterile sexual partner; or female sexual partner who uses an intrauterine device with spermicide, a female condom with spermicide, a contraceptive sponge with spermicide, an intravaginal system, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives) from study entry through at least 3 months after the last dose of study drug. b) Female participants: i. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal) ii.A urine pregnancy test must be negative at screening. The childbearing potential has a negative urine pregnancy test at screening and agrees to one of the following acceptable contraceptive methods used consistently and correctly as outlined below (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study (During screening). a) Complete abstinence from intercourse (when it is preferred and the usual lifestyle of the patient) or b) Implants of levonorgestrel inserted for at least 1 month before the study drug administration but not beyond the third successive year following insertion or c) Injectable progestogen administered for at least 1 month before study drug administration; or d) Oral contraceptive (combined or progestogen-only) administered for at least one monthly cycle before study drug administration; or e) Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or f) An intrauterine device inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year or g) Estrogenic vaginal ring; or h) Percutaneous contraceptive patches. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: Exclusion Criteria: participants are excluded from the study if any of the following criteria apply: 1. Any pathology/underlying condition, which, in the Investigator s opinion, may pose a risk to the patient s participation in the study or may influence either the results of the study or the subject s ability to participate in the study. 2.Chest X-ray within 14 days 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. 3. Patients having moderate to severe exacerbations within 6 weeks before the Screening period. 4. Female patients who are pregnant or lactating or planning a family during the study period. 5. 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. 6. 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 |
|---|---|
| to asses safety of Breztri aerosphere by the estimation of percentage of patients with AEs, SAEs, and AEs leading to discontinuation of study drug Percentage of patients with AEs, SAEs, and AEs leading to discontinuation of study drug Nature, intensity, seriousness, and causal relationship to the study drug Timepoint: Visit1 Week-2 Visit2 Week1 Visit3 Week4 Visit 4 Week8 Visit5 week12 Visit6 Week16 Visit7 Week 20 Visit8 Week24 Visit9 Week28 Visit10 Week32 Visit11 Week36 Visit12 week40 Visit13 Week44 Visit14 week48 Visit15 Week 52 Visit4 Day | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactV V Niranjan Kumar
AstraZeneca Pharma India Ltd
Outcome results
None listed