Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule,Zephir Inhaler Device
- Conditions
- COPD
- Interventions
- Device: Zephir inhaler
- Registration Number
- NCT06254664
- Lead Sponsor
- Xiromed LLC
- Brief Summary
An Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule, Inhaler Device. Zephir inhaler robustness will be assessed by in vitro testing of the Zephir inhaler after 12 weeks of patient use
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tiotropium 18 µg inhalation powder, hard capsule once daily (QD) Zephir inhaler Interventions: Drug: Tiotropium 18 µg inhalation powder, hard capsule Device: Zephir inhaler Tiotropium 18 µg inhalation powder, hard capsule once daily (QD) Tiotropium 18 µg inhalation powder, hard capsule Interventions: Drug: Tiotropium 18 µg inhalation powder, hard capsule Device: Zephir inhaler
- Primary Outcome Measures
Name Time Method In vitro Measurement of Emitted Dose 3 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Vanguard Clinical Research, LLC
🇺🇸Fort Myers, Florida, United States
My Preferred Research LLC
🇺🇸Miami, Florida, United States
Clintex Research Group
🇺🇸Miami, Florida, United States
Vista Health Research
🇺🇸Miami, Florida, United States
Clinical Research Solutions - Orlando
🇺🇸Kissimmee, Florida, United States
Greater Providence Clinical Research, LLC
🇺🇸Cranston, Rhode Island, United States
Inquest Clinical Research, LL
🇺🇸Cypress, Texas, United States
Research Institute of South Florida, Inc.
🇺🇸Miami, Florida, United States
Cliantha Research
🇮🇳Ahmedabad, Gujarat, India