Health Condition 1: J40-J47- Chronic lower respiratory diseases Health Condition 2: J988- Other specified respiratory disorders
Conditions
Interventions
Intervention1: Tiotropium Bromide inhalation spray, 2.5 mcg/puff of Dongguan HEC Pharm R&D Co., Ltd: pilot study is designed as a multicenter, open label, randomized, balanced, two-treatment, single-p
Sponsors
Dongguan HEC Pharm RD Co Ltd
Veeda Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patient of non-child-bearing potential or of childbearing potential but committed to consistent use of an acceptable method of birth control with age of >= 40 years. 2. Diagnosis of COPD, as defined by American Thoracic Society (ATS) [GOLD criteria]. 3. Relatively stable airway obstruction with a post-bronchodilator FEV1 less than 80% of predicted normal and more than 30% of predicted normal, and post-bronchodilator FEV1 / FVC less than 70% 4. Current or former smokers (e.g., with history of more than or equal to 10 pack-years). 5. Patient with adequate bone marrow, renal and hepatic function as defined below: Body system-Parameters Bone marrow function ANC more than or equal to 1500/mm3, Platelet count more than or equal to 100,000/mm3 Hemoglobin more than or equal to 9 g/dL Renal function Serum creatinine less than or equal to 1.5 times ULN and creatinine clearance more than or equal to 51 to 80 mL/min [Cockroft and Gault] Hepatic function Bilirubin less than or equal to 1.5 times ULN, ALT/AST less than or equal 5 times ULN 6. In PIâ??s opinion there is no overt safety concern with regard to two to four weeks of run-in period before first study dose to allow washout of prior COPD medications. 7. Patient willing and able to give written informed consent for participation in the study and comply with the study protocol. 8. No persistent clinically significant toxicities from prior medications at screening. 9. Females of child-bearing potential (FOCP) must agree to use an acceptable method of birth control such as sexual abstinence or at least 2 reliable modes of contraception, one of which must be a double-barrier method (e.g., condom with spermicidal gel or diaphragm with spermicidal gel) or IUD or vaginal spermicidal suppository from screening until the study completion. OR Post-menopausal females defined as at least 12 consecutive months with no menses without an alternative medical cause OR Surgically sterilized females with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy. Females without documented evidence of surgery and those who have undergone tubal ligation will be considered of child bearing potential.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or contraindication to tiotropium bromide or to any of the excipients or to atropine or its derivatives, e.g. ipratropium or oxitropium. 2. 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. 3. History of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, chronic constipation or any other condition, which, in the opinion of the investigator, would contraindicate the use of an anticholinergic agent. 4. 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 participation, or would affect the study analyses if the disease exacerbated during the study. 5. Known active tuberculosis 6. Patients with recent myocardial infarction within last 6 months or any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy in the past year; heart failure (NYHA Class III or IV) within the past year. 7. 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. Hospitalization for COPD or pneumonia within 12 weeks prior to the initiation of the study. 9. Treatment for COPD exacerbation within 12 weeks prior to study. 10. Inability to discontinue COPD medications during the run-in and treatment periods. 11. Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 6 weeks prior to the initiation of the study. 12. Abnormal and significant electrocardiogram (ECG) finding prior to the screening, during the run-in and treatment periods. 13. Lung volume reduction surgery within 12 months prior to the initiation of the study 14. Chronic oxygen use for more than 12 hours/day. 15. Subject with positive human immunodeficiency virus (HIV) infection, a positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies. 16. Positive test results for urine drug scan or breath alcohol test at baseline 17. Subject with a history of difficulty in donating blood or difficulty in accessibility of veins. 18. Receipt of any Investigational Medicinal Product within the past 30 days of randomization or has less than 5 half-life from previous IMP receipt. 19. History of donation of blood/loss of blood (without replenishment) (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate bioequivalence of Tiotropium Bromide inhalation spray, 2.5 mcg/puff of Dongguan HEC Pharm R&D Co., Ltd.in comparison with that of Spiriva® Respimat® (tiotropium bromide) spray, 2.5 mcg/puff of Boehringer Ingelheim Pharma GmbH & Co.KGTimepoint: On Day 1 and Day 28: Serial spirometry (FEV1) will be measured at pre-dose (0.00) and at 5 min, 30 min, 1, 2, 4, 6, 8, 10, 12 and 24 hours after dosing. Calibrated spirometer will be used for the measurement of spirometry. The above BE study end-point will be baseline-adjusted (change from baseline). Spirometry measurements will be performed and interpreted in accordance with ATS guidelines | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess PK characteristicsTimepoint: On Day 14 and Day 28: The pre-dose blood sample of 06 mL (0.00) will be collected within 15 min prior to dose administration on Day 14 and day 28. For each patient, a total of 18PK samples will be collected during the study | — |
Countries
India
Contacts
Public ContactDrAshoka Kumar Singh
Veeda Clinical Research Pvt.Ltd.
Outcome results
None listed