A Multicenter, Prospective, Open Label, Single arm, Phase IV Study to Assess the Safety and Effectiveness of Fixed Dose Combination of Vilanterol Trifenatate eq. to 25 mcg Vilanterol 40 mcg and Glycopyrronium Bromide eq. to 50 mcg Glycopyrronium 63 mcg Powder for Inhalation in Capsule indicated as maintenance treatment for Patients with Chronic Obstructive Pulmonary Disease.
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Lupin Ltd
- Enrollment
- 200
- Locations
- 6
- Primary Endpoint
- Safety of patient will be monitored throughout the study
Overview
Brief Summary
COPD is a common preventable, and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation due to abnormalities in the airway and (or) alveolar abnormalities.
It is the leading cause of disability among chronic respiratory diseases and was the second leading contributor of Disability Adjusted Life Years (DALY) in 2016. In 2016, nearly 32% of global DALYs due to COPD occurred in India and COPD is responsible for 75.6% of total DALYs among chronic respiratory disease in India.
The Purpose of the Study is to evaluate the safety of FDC of Vilanterol Trifenatate eq. to 25 mcg Vilanterol 40 mcg + Glycopyrronium Bromide eq. to 50 mcg Glycopyrronium 63 mcg indicated as maintenance treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD)
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Males and females aged 18 years and above.
- •2.mMRC ≥2 even after receiving monotherapy (LABA or LAMA) or dual therapy (LABA + ICS) for at least 4-6 weeks at the time of screening.
- •3.COPD Assessment Test (CAT) score ≥ 10 even after receiving monotherapy (LABA or LAMA), dual therapy (LABA + ICS) for at least 4-6 weeks at the time of screening.
- •4.Willing to take the medications as directed.
- •5.Willing to comply with the protocol requirements.
- •6.Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.
- •7.Post-menopausal female patients, or female of child bearing age must agree to use highly effective contraceptive measures with her partner during the study and for 90 days following their last dose.
Exclusion Criteria
- •1.Known hypersensitivity to Glycopyrronium, Vilanterol, other beta-2 agonists, other anti-muscarinic agents, or excipients of formulation.
- •2.Known α1-antitrypsin deficiency.
- •3.Known history of HIV or HBV or HCV infection 4.COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period.
- •5.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.Known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention.
- •8.Clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy.
- •9.Known history of hepatic dysfunction.
- •10.With continuing history of alcohol and/or drug abuse.
- •11.Not willing to give written informed consent.
Outcomes
Primary Outcomes
Safety of patient will be monitored throughout the study
Time Frame: 6 weeks
Patients with Adverse Events (AEs)
Time Frame: 6 weeks
Incidence rate of AEs (Serious/non-serious, Expected/Non- expected, Related/ Non-related)
Time Frame: 6 weeks
Secondary Outcomes
- Mean change in COPD Assessment Test (CAT) score at week 12 from baseline.(Proportion of patients with improvement in modified Medical Research Council (mMRC) score at end of week 12.)
Investigators
Jamnadas Kushwaha
Raptim Research Pvt. Ltd.