Health Condition 1: J44- Other chronic obstructive pulmonary disease
Conditions
Interventions
Intervention1: Tiotropium Bromide Inhalation
Powder
: 18 mcg, Single dose of 18 mcg, in each period
Control Intervention1: Tiotropium Bromide Inhalation
Powder: 18 mcg, Single dose of 18 mcg, in each
Sponsors
Alvogen Pine Brook R&D LLC.
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female patient must be of grater than or equal to 40 years of age at screening Visit 1 2. Diagnosis of COPD, as defined by American Thoracic Society (ATS) [Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) criteria] at screening Visit 1 3. At first (Visit 1) or second (Visit 2) Screening Visit, post-bronchodilator FEV1 less than or equals to 80 percent and greater than or equals to 40 percent of predicted normal values as per Global Lung Function Initiative (GLI-2012) after 4 puffs of salbutamol used as per GOLD 2024. 4. At first (Visit 1) or second (Visit 2) Screening Visit. Post-bronchodilator FEV1/FVC ratio less than or equals to 0.70. 5. Pre-bronchodilator FEV1 greater than or equals to 35% and less than or equals to 80% of predicted at first screening (Visit 1) or second screening (Visit 2). 6. Predose FEV1 values at Visits 4 and 5 within 20% of the Visit 3 Predose FEV1. 7. Patient must administer at least 70% doses of placebo during the run-in period. 8. Patient is a current smoker or former smoker with history of grater than or equal to 10 pack-years [Note: Pack-Year= (cigarettes smoked per day x years smoked)/20]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to screening Visit 1. 9. General good health (except the COPD diagnosis) and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results or put the patient at increased risk during the study as per the discretion of the Investigator. 10. Male patient, who is sexually active, committed to the consistent and correct use of an acceptable method of birth control for the duration of the study. 11. Female with postmenopausal status or child bearing potential with negative pregnancy test must agree to practice an acceptable method of contraception throughout the study duration. Postmenopausal is defined by any one of the following: a. Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments. b. Radiation-induced oophorectomy with last menses greater than 1 year ago. c. Chemotherapy-induced menopause with greater than 1 year interval since last menses. d. At least 6 months post-surgery following bilateral oophorectomy with or without hysterectomy. 12. Patient is able to understand and comply with the study procedures, in the opinion of the investigator. 13. Patient willing to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Known respiratory disorders other than COPD including, but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease. 2. Patient with evidence or history of other clinically significant disease or abnormality (such as congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, stroke, glaucoma, or cardiac dysrhythmia), which, in the opinion of the investigator, would put the patient at risk through study patient, or would affect the study analyses if the disease exacerbated during the study. 3. Patient with history of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. 4. Presence or history of urinary retention. 5. Known active tuberculosis. 6. Patient with history of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, or any other condition, which, in the opinion of the investigator, would contraindicate the use of an anticholinergic agent. 7. Patient with history of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or specific intolerance to aerosolized tiotropium-containing products or known hypersensitivity to any of the proposed ingredients or components of the delivery system. 8. Patient with hospitalization for COPD or pneumonia within 12 weeks prior to screening Visit 1. 9. Patient with treatment for COPD exacerbation within 12 weeks prior to screening Visit 1. 10. Patient who is unable to discontinue COPD medications during the placebo run-in and treatment periods. 11. Patient with chronic oxygen use for Grater than 12 hours/day. 12. Patient with lung volume reduction surgery within 12 months prior to screening Visit 1. 13. Patient with abnormal and significant electrocardiogram (ECG) finding at the time of screening. the time of screening. 14. Patient with acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 6 weeks prior to screening Visit 1 and during the placebo run-in period. 15. Patient who is medically unable to withhold his/her short-acting B2-agonists for at least 6 hours prior to spirometry on each clinic visit at the discretion of the investigator. 16. Use of immediate-release (Oral or IV) corticosteroids within the last 30 days and/or extended-release corticosteroids (Depot or Local) within the last 12 weeks prior to the Screening Visit 1. 17. Patient with a history of asthma or a clinical diagnosis of asthma, allergic rhinitis, or atopy; a total blood eosinophil count above 600/mm3 18. Major surgery within 2 months prior to the Screening Visit (Visit 1) or patient not recovered from any undesirable or harmful effects of any major surgery. 19. Patient with known serum positivity for Hepatitis B, C or HIV. 20. Pregnant, or breast-feeding, or planning to become pregnant during the study. 21. Patient in any investigational drug study within 30 days prior to screening Visit 1. 22. History of drug depend
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the serial FEV1-time curve (baseline adjusted) calculated from time 0 to 24 hours (i.e., AUC0-24h) after the single dose of the treatment. Baseline FEV1 is considered as the average of the pre-dose FEV1 values on the day of treatment (Visit 3, Visit 4 and Visit 5) prior to taking the single dose of the assigned treatment.Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum FEV1 response [difference between peak FEV1 and FEV1 at baseline (pre-dose)] and Time to the maximal response (Tmax)].Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed