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This study is to characterize the pharmacodynamic characteristics and to assess the therapeutic bioequivalence after single dose of Tiotropium Bromide Inhalation Powder-test relative to Tiotropium Bromide Inhalation Powder-reference in Adult Patients with Chronic Obstructive Pulmonary Disease (COPD) as primary objective
Pharmadynamic study conducted in accordance requirements and recommendations per the US FDA's 2017 product specific "Draft Guidance on Tiotropium Bromide"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder) | Experimental | 2 inhalations of test product, followed by 2 inhalations of reference placebo product |
|
| Treatment B: 18 mcg of Reference Product (Spiriva) | Active Comparator | 2 inhalations of reference product, followed by 2 inhalations of test placebo product |
|
| Treatment C: Zero-dose (Placebo) | Placebo Comparator | 2 inhalations of reference placebo powder, followed by 2 inhalations of test placebo product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product (tiotropium bromide inhalation powder) | Combination Product | A single dose of test product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary PD parameter - Adjusted area under the serial spirometry FEV1-time curve | Baseline-adjusted area under the serial spirometry FEV1-time curve calculated from time 0 to 24 hours (AUC0-24h) following treatment | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site 203 | Anderson | South Carolina | 29621 | United States | ||
| Investigational Site 204 |
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Double-blind, double-dummy, placebo controlled
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| 18 mcg of Spiriva (Reference Product) | Combination Product | A single dose of reference product (Spiriva) |
|
|
| Placebo | Combination Product | A single dose of placebo |
|
| Gaffney |
| South Carolina |
| 29340 |
| United States |
| Investigational Site 205 | Union | South Carolina | 29379 | United States |
| Investigational Site 119 | Ahmedabad | Gujarat | 380006 | India |
| Investigational Site 101 | Ahmedabad | Gujarat | 382345 | India |
| Investigational Site 120 | Gandhinagar | Gujarat | 382421 | India |
| Investigational Site 108 | Sābarmatī | Gujarat | 380005 | India |
| Investigational Site 114 | Surat | Gujarat | 395006 | India |
| Investigational Site 102 | Vadodara | Gujarat | 390012 | India |
| Investigational Site 107 | Vadodara | Gujarat | 390022 | India |
| Investigational Site 118 | Jammu | Jammu and Kashmir | 190001 | India |
| Investigational Site 106 | Nagpur | Maharashtra | 440009 | India |
| Investigational Site 105 | Nagpur | Maharashtra | 440015 | India |
| Investigational Site 121 | Nashik | Maharashtra | 422002 | India |
| Investigational Site 112 | Nashik | Maharashtra | 422101 | India |
| Investigational Site 111 | Pune | Maharashtra | 411038 | India |
| Phargentis SA (Central Contact) | Barbengo | 6917 | Switzerland |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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