Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Revefenacin 175 mcg in 3 ml Inhalation Solution manufactured by BDR Pharmaceuticals International Pvt Ltd India: Patients will be administered with the Revefenacin 175 mcg in 3 ml Inhal
Sponsors
BDR Pharmaceuticals International Pvt Ltd
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients equal or above to 40 years of age with a history of COPD disease Categorised under Group B and E as per GOLD Guideline Females may be of either childbearing or non childbearing potential All females of childbearing potential must be using an acceptable highlyeffective method of contraception and have a negative pregnancy test at screening Post ipratropium FEV1 FVC ratio lesser 0.7 and post ipratropium FEV1 lesser 80 percent of the predicted normal value but equal or above 700 ml at the screening visit corresponding to GOLD grade 2 or 3 as per GOLD guidelines Current smoker or ex smoker with a history of at least 10 pack years of tobacco smoking Ex smokers must have stopped smoking more than 6 months prior to Visit 1 Patients must be on stable dose and treatment with either triple therapy a long acting muscarinic antagonist LAMA a long acting beta agonist LABA and an inhaled corticosteroid ICS or dual therapy consisting of LAMA plus LABA for at least 4 weeks prior to screening Patients receiving triple therapy may be on fixed dose combinations such as Formoterol Budesonide or Salmeterol Fluticasone propionate along with Tiotropium LAMA therapy will be continued up to the day of randomization and dosing On Day 1 patients will be directly switched to the assigned study medication either Revefenacin or Tiotropium LABA ICS therapy will remain unchanged throughout the study Patients capable of performing reliable spirometry testing and adhering to inhalation techniques as instructed Patients willing and able to comply with study procedures scheduled visits and treatment requirements throughout the study duration Estimated glomerular filtration rate eGFR greater or equal to 60 mL per min per 1.73 m sq during screening Ability to understand and complete questionnaires SGRQ TDI in the language provided
Exclusion criteria
Exclusion criteria: Patients has known allergies hypersensitivity or intolerance to any of the active substances Revefenacin or to any of its excipients History of myocardial infarction or unstable angina within the previous 6 months unstable or life threatening cardiac arrhythmia requiring intervention within the previous 3 months New York Heart Association Class IV heart failure prior to the start of the study or exhibited an abnormal and clinically significant 12 lead electrocardiogram finding at study entry Previously Dosed with Revefenacin in any prior clinical study or therapy Current diagnosis of asthma Uncontrolled Comorbid conditions including Hypertension hypercholesterolemia or type 2 diabetes Other chronic or active respiratory disorder eg clinically significant as determined by the Investigator bronchiectasis pulmonary fibrosis sarcoidosis pneumoconiosis active tuberculosis Acute exacerbation of COPD AECOPD requiring antibiotics and or systemic oral corticosteroids or hospitalization within 28 days prior to screening or during the screening period between Visit 1 and Visit 3 Pneumonia requiring hospitalization within 28 days prior to screening or during the screening period between Visit 1 and Visit 3 Lower respiratory tract infection requiring treatment with antibiotics during the 28 days preceding screening or during the screening period between Visit 1 and Visit 3 History or presence of pulmonary hypertension respiratory failure cor pulmonale or right ventricular failure which may impact the safety of the subject in the clinical judgement of the Investigator History of pulmonary lobectomy lung volume reduction surgery or lung transplantation Use of supplemental oxygen therapy for more than 15 hours per day includes night time use Patients with moderate to severe hepatic impairment Child Pugh Class B or C or with ALT per AST greater than 2.5 X ULN or total bilirubin greater than 1.5 X ULN Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics including narrow angle glaucoma symptomatic benign prostatic hyperplasia bladder neck obstruction or urinary retention Subjects who are unable to stop any of the following medications and refrain from their use throughout the study until the final dose of study drug Short acting beta 2 agonists Short acting muscarinic antagonist except those used for reversibility testing Long acting muscarinic antagonist except study supplied medication Phosphodiesterase 4 inhibitors Theophyllines Leukotriene inhibitors Orally inhaled nedocromil or cromolyn sodium Oral or systemic corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1Timepoint: 06 Time points Day 01 Day 15 Day 29 Day 57 Day 78 and Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall treatment effect OTE on trough FEV1 defined as the inverse variance weighted average of all the trough FEV1 assessments across days 15 through 85 15 29 57 & 85 & peak maximum FEV1 0 to 2 hours post first dose on day 1 Patient reported outcomes Improvement in Quality of Life QoL as measured by the St Georges Respiratory Questionnaire SGRQ Change in dyspnea severity assessed using the Transition Dyspnea Index TDI Monitoring & documentation of adverse events AEs throughout the study period Timepoint: 06 Time points Day 01 Day 15 Day 29 Day 57 Day 78 & Day 85 | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and research private limited
Outcome results
None listed