CTRI/2025/12/099427Not yet recruitingPhase 4
The Safety and Effectiveness of Fixed dose combination of Budesonide, Glycopyrronium and Formoterol Fumarate Dihydrate, 200mcg/12.5mcg/6mcg) Metered Dose Inhaler (MDI) for maintenance treatment of Chronic Obstructive Pulmonary Disease patients: A Multicenter, Prospective, Open Label, Single arm, Phase IV Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Lupin Limited
- Enrollment
- 200
- Locations
- 7
Study Overview
Brief Summary
The Safety and Effectiveness of Fixed dose combination of Budesonide, Glycopyronium and Formoterol Fumarate Dihydrate, (200mcg/12.5mcg/6mcg) Metered Dose Inhaler (MDI) for maintenance treatment of Chronic Obstructive Pulmonary Disease patients: A Multicenter, Prospective, Open Label, Single arm, Phase IV Study. Total population is 200 patients and Treatment duration is of 12 weeks. Primary objective of the study is To assess the safety of FDC of Budesonide, Glycopyronium and Formoterol Fumarate Dihydrate, (200mcg/12.5mcg/6mcg) Metered Dose Inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD) , while secondary objective of the study is to evaluate the effectiveness of FDC of Budesonide, Glycopyronium and Formoterol Fumarate Dihydrate, (200mcg/12.5mcg/6mcg) Metered Dose Inhaler in patients with COPD.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either gender, aged 18 years or above.
- •Patients diagnosed with COPD according to the GOLD 2025 guidelines.
- •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.
- •Patients willing to provide written informed consent, literate enough to fill the diary card, and comply with the protocol requirements.
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.
Investigators
Dr Jayesh Sanmukhani
Clinexcel Research
Study Sites (7)
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