Health Condition 1: J44- Other chronic obstructive pulmonary disease
Conditions
Interventions
Intervention1: Test Product (T):
FDC of Glycopyrronium (12.5 mcg) + Formoterol Fumarate Dihydrate (6 mcg) + Fluticasone Propionate (125 mcg) MDI
Treatment Period(Duration): 12 Week
Route of Administr
Sponsors
Lupin Ltd.,
Raptim Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients, aged more than equal to 18 to less than equal to 75 years at screening Patients with a diagnosis of COPD (as defined by the GOLD COPD report 2025) Post-bronchodilator FEV1 more than equal to 30 percentage and less than 80 percentage of the predicted normal value and post-bronchodilator FEV1-FVC (forced vital capacity) ratio 0.70 A modified Medical Research Council dyspnea scale (mMRC) grade 2 COPD Assessment Test (CAT) score more than equal to 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4-6 weeks at the time of screening. History of exacerbations (more than equal to 2 moderate or more than equal to 1 severe exacerbation) of COPD within 12 months before screening. Subjects on inhaled corticosteroid (ICS) with or without a long-acting Beta 2 agonist (LABA) (as a free or fixed combination), or ICS with a long-acting muscarinic antagonist (LAMA), or LABA with LAMA (as a free or fixed combination), or LAMA monotherapy as maintenance treatment for at least 1 month before screening. Willingness to give their written informed consent to participate in the study and willingness to comply with study requirements and procedures. Female subjects with negative pregnancy tests, and agreed to use adequate forms of non hormonal contraception during the study (i.e. women of childbearing potential used a highly effective method of birth control, such as condom and spermicide, diaphragm or cervical cap and spermicide, condom and diaphragm or cervical cap, non hormonal IUD), or females who were of non child bearing potential i.e. who were surgically sterile (history of hysterectomy or bilateral tubal ligation or bilateral oophorectomy; partial hysterectomy is not sufficient or vasectomized partner) or postmenopausal (12 months of spontaneous amenorrhea), or who agreed to remain abstinent. Ability to use metered dose inhaler independently and correctly as instructed by the investigator
Exclusion criteria
Exclusion criteria: 1. Patient unable to perform study procedures or not willing to give informed consent 2. Patients already receiving triple drug treatment with LABA+LAMA+ICS (either in the form of SITT or MITT) 3. Patients with co-existing comorbidity such as tuberculosis, alpha-1 antitrypsin deficiency, cystic fibrosis, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease 4. Evidence or history of other clinically significant cardiovascular disease or abnormality (such as, but not limited to, congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infraction, arrhythmia, long QT syndrome, atrial fibrillation), renal, neurological, endocrine, immunological, psychiatric, hepatic, or hematological disease or abnormality which, in the opinion of the investigator, will clinically significant and have put the patient at risk through study participation, or would have affected the study analyses if the disease exacerbates during the study 5. Significant abnormality that suggests chest disease other than COPD, on chest X-ray or computed tomography (CT) scan taken within six months before screening. If there was no chest X-ray/CT scan taken within six months prior to screening, a chest X-ray will be performed during screening to rule out any other significant abnormality. 6. History of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, severe renal impairment or urinary retention, or any other condition, which, in the opinion of the investigator, would have contraindicated the use of an anticholinergic or long-acting beta agonist agent 7. History of allergy or hypersensitivity to any of the ingredients of study drugs or components of the delivery system 8. Hospitalization for COPD exacerbation or pneumonia within three months prior to screening. 9. Use of oral/parenteral corticosteroids or antibiotics for COPD exacerbation within six weeks prior to screening. 10. A clinically significant abnormal electrocardiogram (ECG) at screening. 11. Lung volume reduction surgery within 12 months prior to the initiation of the study. 12. Requirement of long-term (12 hours daily) oxygen therapy. 13. Unable to stop the following medications at the defined times prior to screening spirometry: a. Ipratropium or ipratropium/salbutamol combination product-8 hours, Inhaled short-acting beta-agonists 6 hours, Oral beta2-agonists 48 hours, Long-acting beta-agonists (salmeterol and formoterol) or ICS/LABA combination products-48 hours, b. Xanthines- 48 hours, Cromolyn and nedocromil inhalers 24 hours c. Zafirlukast, montelukast, zileuton- 48 hours d. Long-acting anticholinergics (Tiotropium etc.)-48 hours e. Oral or parenteral corticosteroids- 6 weeks f. Any other investigational medication 30 days or 5 half-lives of the investigational drug (whichever is longer), g. Depot corticosteroids- 3 months, h. Inhaled corticosteroids (ICS)- Washout not required 14. Currently enrolled in another interventional clinical study or have used any IPs, study drug, or device within 30 days or 5 times the half-life, whichever is longer preceding informed consent or scheduled to participate in another clinical study involving an IP. 15. Patients who are currently taking alcohol pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of SITT of Glycopyrronium, Formoterol Fumarate and Fluticasone Propionate MDI versus SITT of Budesonide, Glycopyrronium and Formoterol Fumarate Dihydrate MDI in moderate to severe COPD patients.Timepoint: Mean change of FEV1 test from baseline to end of week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of SITT of Glycopyrronium, Formoterol Fumarate & Fluticasone Propionate MDI versus SITT of Budesonide, Glycopyrronium & Formoterol Fumarate Dihydrate MDI in moderate to severe COPD patients.Timepoint: Mean change of FEV1 test from baseline to end of week 4 Mean change of 2 hours post-dose FEV1 from baseline to week 12 Proportion of patients with COPD exacerbations during the treatment period of 12 Weeks Mean change of mMRC Dyspnea score from baseline to week 4 & week 12 & CAT score from baseline to week 12. Proportion of patients with COPD related hospitalization during the treatment period of 12 weeks. Proportion COPD related/all cause death during the treatment period of 12 weeks. | — |
Countries
India
Contacts
Public ContactDr Siddhartha Patil
Raptim Research Pvt. Ltd
Outcome results
None listed