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

NCT06254664 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-02-12

No results posted yet for this study

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

Conditions

Interventions

DRUG

Tiotropium 18 µg inhalation powder, hard capsule

Tiotropium 18 µg administered using Zephir inhaler

DEVICE

Zephir inhaler

Tiotropium 18 µg administered using Zephir inhaler

Sponsors & Collaborators

  • Laboratorios Liconsa

    collaborator INDUSTRY

  • Xiromed LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2023-07-07
Completion
2023-10-27
FDA Drug
Yes

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06254664 on ClinicalTrials.gov