Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness
Public ClinicalTrials.gov record NCT03137992. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover, Multicenter Clinical Study to Assess the Efficacy and Safety of Once Daily Administration of Lupin Tiotropium Bromide Inhalation Powder Compared to SPIRIVA® HANDIHALER® and Placebo in Patients With COPD Including a 12-Week Open Label Extension to Assess Inhaler Robustness
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (FEV1).
Study identification
- NCT ID
- NCT03137992
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 377 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- Test Product (tiotropium bromide inhalation powder) Drug
- Reference Product (Spiriva®) Drug
Drug
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 21, 2017 (Actual)
- Primary completion
- Jan 31, 2018 (Actual)
- Completion
- Apr 30, 2018 (Actual)
- Last update posted
- Apr 5, 2021
2017 – 2018
United States locations
- U.S. sites
- 34
- U.S. states
- 17
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Research Center Site #1017 | Andalusia | Alabama | 36420 | — |
| Investigational Research Center Site #1003 | Jasper | Alabama | 35501 | — |
| Investigational Research Center Site #1008 | Glendale | Arizona | 85306 | — |
| Investigational Research Center Site #1034 | Los Angeles | California | 90025 | — |
| Investigational Research Center Site #1028 | Riverside | California | 92506 | — |
| Investigational Research Center Site #1010 | Westminster | California | 92683 | — |
| Investigational Research Center Site #1016 | Colorado Springs | Colorado | 80907 | — |
| Investigational Research Center Site #1026 | Clearwater | Florida | 33756 | — |
| Investigational Research Center Site #1019 | Clearwater | Florida | 33765 | — |
| Investigational Research Center Site #1035 | Clearwater | Florida | 33765 | — |
| Investigational Research Center Site #1036 | Orlando | Florida | 32825 | — |
| Investigational Research Center Site #1001 | North Dartmouth | Massachusetts | 02747 | — |
| Investigational Research Center Site #1011 | Fridley | Minnesota | 55432 | — |
| Investigational Research Center Site #1029 | St Louis | Missouri | 63141 | — |
| Investigational Research Center Site #1007 | Las Vegas | Nevada | 89119 | — |
| Investigational Research Center Site #1032 | Raleigh | North Carolina | 27607 | — |
| Investigational Research Center Site #1037 | Columbus | Ohio | 43215 | — |
| Investigational Research Center Site #1018 | Edmond | Oklahoma | 73034 | — |
| Investigational Research Center Site #1009 | Oklahoma City | Oklahoma | 73103 | — |
| Investigational Research Center Site #1033 | Tulsa | Oklahoma | 74136 | — |
| Investigational Research Center Site #1005 | Medford | Oregon | 97504 | — |
| Investigational Research Center Site #1006 | Portland | Oregon | 97202 | — |
| Investigational Research Center Site #1015 | Easley | South Carolina | 29640 | — |
| Investigational Research Center Site #1012 | Gaffney | South Carolina | 29340 | — |
| Investigational Research Center Site #1023 | Rock Hill | South Carolina | 29732 | — |
| Investigational Research Center Site #1024 | Seneca | South Carolina | 29678 | — |
| Investigational Research Center Site #1020 | Spartanburg | South Carolina | 29303 | — |
| Investigational Research Center Site #1025 | Spartanburg | South Carolina | 29303 | — |
| Investigational Research Center Site #1027 | Union | South Carolina | 29379 | — |
| Investigational Research Center Site #1004 | Knoxville | Tennessee | 37909 | — |
| Investigational Research Center Site #1013 | El Paso | Texas | 79903 | — |
| Investigational Research Center Site #1002 | McKinney | Texas | 75069 | — |
| Investigational Research Center Site #1030 | New Braunfels | Texas | 78130 | — |
| Investigational Research Center Site #1031 | Newport News | Virginia | 23606 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03137992, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 5, 2021 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03137992 live on ClinicalTrials.gov.