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NCT06254664Completed

Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule,Zephir Inhaler Device

Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule, Zephir Inhaler Device
Xiromed LLCPhase 1ClinicalTrials.govdrug
Study focus
Disease/Condition
COPD
Drug/Device/Intervention
Tiotropium 18 µg inhalation powder, hard capsule
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Xiromed LLC
Location
Fort Myers,Kissimmee,Miami,Miami,Miami,Miami,Cranston,Cypress,Ahmedabad, India,United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Oct 03, 2022
End date
Oct 27, 2023
Enrollment
116 participants
Primary outcome

In vitro Measurement of Emitted Dose

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

ICD-10 classifications
Chronic obstructive pulmonary disease, unspecifiedOther chronic obstructive pulmonary diseaseOther specified chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease with acute exacerbation, unspecifiedPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06254664
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06254664 through Pure Global AI's free database. This Phase 1 trial is sponsored by Xiromed LLC and is currently Completed. The study focuses on COPD. Target enrollment is 116 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.