A clinical study to assess the efficacy and safety of Vilanterol, Glycopyrronium and Fluticasone furoate Inhalation in patients with Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic obstructive pulmonary disease, unspecified,
- Registration Number
- CTRI/2023/02/049362
- Lead Sponsor
- Zydus Healthcare Limited
- Brief Summary
This will be a prospective, randomized, double-blind, parallel, active-controlled, multicenter, non-inferiority study planned to evaluate the efficacy and safety of the test drug, Vilanterol, Glycopyrronium and Fluticasone furoate Inhalation 12.5 mcg, 25 mcg and 50 mcg as compared to the reference drug, Glycopyrrolate, Formoterol Fumarate and Budesonide Inhalation 9 mcg, 4.8 mcg and 160 mcg in the patients with moderate to severe COPD. The test drug is indicated for once daily dosing while the reference drug is indicated for twice daily dosing. Due to this difference in dosing of the test and the reference drugs, a MDI containing placebo will be used for the patients enrolled in the test group to maintain double-blinding. All the MDIs containing the test drug, the reference drug or the placebo will have identical physical characteristics and will be indistinguishable from each other. Randomization will prevent the selection / treatment allocation bias and double-blinding will prevent the bias in the assessment of treatment effects. Randomized patients will be enrolled in either of the 2 study groups as per their randomization number and will be followed up in a parallel manner till the completion of study. Patients with moderate to severe COPD receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) and satisfying the below Inclusion & Exclusion will be enrolled in this study. A total of 220 patients at multiple centres geographically distributed over the country will be enrolled in this clinical trial. Enrollment at various clinical trial sites will be competitive. In this study, the patients with moderate to severe COPD receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) will be screened (visit1) within 3 days prior to their enrolment. The eligible patients will then be enrolled and randomized to either of the 2 study groups as per their randomization number on baseline visit (visit 2, day 0). After randomization, patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 3), week 8 (visit 4) and week 12 (visit 5). This will be a parallel group study and all the enrolled patients will be instructed to take the allocated study medications for a treatment period of 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 220
- Patients of either gender between 40-65 years of age (both inclusive) 2.
- Patients who are current/ex-smokers 3.
- Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit: a.
- Post-bronchodilator FEV1/FVC ratio < 0.7; b.
- Post-bronchodilator FEV1, ≥ 30% to < 80% predicted 4.
- COPD Assessment Test (CATTM) score ≥ 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4 weeks at the time of screening 5.
- Patients willing to provide written informed consent and comply with the protocol requirements 6.
- Patients literate enough to fill the diary card.
- Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
- Patients with known hypersensitivity to formoterol, vilanterol, glycopyrronium, fluticasone, budesonide, salbutamol, other beta-2 agonists or other antimuscarinic agents 3.
- Patients diagnosed with COVID-19 within 3 months prior to screening 4.
- Patients with known α1 antitrypsin deficiency 5.
- COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period 6.
- Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period 7.
- Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period 8.
- Patients who required long-term oxygen therapy (≥12 hours/day) within 4 weeks prior to the screening or during the screening period 9.
- Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention 10.
- Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 11.
- Patients with hepatic dysfunction (serum transaminases ≥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dl) at screening 12.
- Patients who have used prohibited medications 13.
- Patients with continuing history of alcohol and/or drug abuse 14.
- Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 15.
- Any other reason for which the investigator feels that the patient should not participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in trough FEV1 at the end of the study in the two groups 12 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in trough FEV1 at week 4 in the two groups
Trial Locations
- Locations (8)
Aatman Hospital
🇮🇳Ahmadabad, GUJARAT, India
AIIMS, Patna
🇮🇳Patna, BIHAR, India
GMRS Medical College and General Hospital
🇮🇳Vadodara, GUJARAT, India
Govt. Medical College Govt.General Hospital Balaga Srikakulam
🇮🇳Srikakulam, ANDHRA PRADESH, India
Jeevan Rekha Hospital
🇮🇳Belgaum, KARNATAKA, India
Kanungo Institute of Diabetes Specialties
🇮🇳Baleshwar, ORISSA, India
New Leelamani Hospital
🇮🇳Dehat, UTTAR PRADESH, India
Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital
🇮🇳Kolhapur, MAHARASHTRA, India
Aatman Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Chintan B PatelPrincipal investigator9825182251cr.aatman@gmail.com