Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Budesonide, Glycopyrronium and Formoterol Fumarate Dihydrate, 200mcg/12.5mcg/6mcg: Two actuation twice daily for 12 weeks
Control Intervention1: NIL: NIL
Sponsors
Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender, aged 18 years or above. 2. Patients diagnosed with COPD according to the GOLD 2025 guidelines. 3. COPD Assessment Test (CAT) score more than or equal to 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 6 weeks at the time of screening. 4. Patients willing to provide written informed consent, literate enough to fill the diary card, and comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Patients with known hypersensitivity to Budesonide, Glycopyronium and Formoterol, other beta 2 agonists, other anti-muscarinic agents or other corticosteroids. 2.Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc. 3.Patients with known alpha 1 antitrypsin deficiency 4.COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period 5.Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period 6.Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period 7.Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention 8.Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 9.Patients with hepatic dysfunction (Serum Glutamic Oxaloacetic Transaminase (SGOT) & Serum Glutamic Pyruvic Transaminase (SGPT) more than or equal to 3 times Upper Normal Limit) or renal dysfunction (serum creatinine more than or equal to 2.5 mg/dl) at screening 10.Patients with continuing history of alcohol and/or drug abuse 11.Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 12.Participation in another clinical trial in the past 3 months 13.Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with adverse events (AEs) & Incidence rate of AE (Serious/ Non Serious , Expected / Non-expected , Related / Non Related)Timepoint: Baseline to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in CAT scoreTimepoint: Baseline vs at week 6 and Week 12;Proportion of subjects with improvement in mMRC scoreTimepoint: Baseline vs at week 6 and Week 12;Proportion of patients with COPD exacerbationsTimepoint: Basline to End of study | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Clinexcel Research
Outcome results
None listed