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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06254664
Other study ID # TioDPI PuR-01 (C2A02205)
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 3, 2022
Est. completion date October 27, 2023

Study information

Verified date February 2024
Source Xiromed LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date October 27, 2023
Est. primary completion date July 7, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria (abbreviated): 1. Capable of understanding the requirements, risks, and benefits of study participation, and as judged by the Investigator, capable of giving written informed consent. 2. Male or non-pregnant female subjects between 40 to 75 years of age at Screening Visit (Visit 1) diagnosed with COPD. 3. General good health (except the COPD diagnosis) and free of any concomitant conditions that would put the subject at increased risk during the study as per the discretion of the Investigator. 4. An established physician diagnosis of COPD as defined by GOLD 2022. 5. At Screening Visit, post-bronchodilator FEV1=80% and =40% of predicted normal values as per Global Lung Function Initiative (GLI-2012) - and post-bronchodilator FEV1/FVC ratio =0.70. 6. Current COPD Therapy: Subjects must be on stable regimens of one of the following for at least 8 weeks prior to screening (Visit 1): - Long-acting muscarinic antagonist (LAMA) - LAMA+LABA - Inhaled corticosteroids + LAMA 7. Current or ex-smokers with =10 pack-year smoking history (Note: Pack- Year= (cigarettes smoked per day x years smoked)/20)). 8. No occurrence of an upper or lower respiratory tract infection 14 days before Screening Visit. 9. No COPD exacerbation, defined as any worsening of COPD requiring an emergency department visit or hospitalization, or the use of antibiotics (strong CYP450 3A4 inhibitors with = 14 days of acute non-respiratory 10. Ability to adequately use the Test inhaler. Exclusion Criteria (Abbreviated): 1. Treatment for mild-moderate COPD exacerbations within 4 weeks prior to the Screening Visit (Visit 1) or more exacerbations in the last year. 2. Hospitalization for COPD or pneumonia within 12 weeks prior to the Screening Visit (Visit 1). 3. History of a life-threatening COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest, hypoxic seizures, or mMRC (Modified Medical Research Council) dyspnea Grade 4. 4. Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 4 weeks prior to the Screening Visit (Visit 1). 5. Subjects with a history of asthma or a clinical diagnosis of asthma, allergic rhinitis, or atopy; a total blood eosinophil count above 600/mm3. 6. Historical or current evidence of a clinically significant disease 7. Have any of the following conditions that, in the judgment of the Investigator, might cause participation in this study to be detrimental to the subject. 8. A subject must not have any clinically significant, uncontrolled condition, or disease state that, in the opinion of the Investigator, would put the safety of the subject at risk through study participation. 9. History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or specific intolerance to aerosolized tiotropium-containing products or its derivatives.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
India Cliantha Research Ahmedabad Gujarat
United States Greater Providence Clinical Research, LLC Cranston Rhode Island
United States Inquest Clinical Research, LL Cypress Texas
United States Vanguard Clinical Research, LLC Fort Myers Florida
United States Clinical Research Solutions - Orlando Kissimmee Florida
United States Clintex Research Group Miami Florida
United States My Preferred Research LLC Miami Florida
United States Research Institute of South Florida, Inc. Miami Florida
United States Vista Health Research Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
Xiromed LLC Laboratorios Liconsa

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type Measure Description Time frame Safety issue
Primary In vitro Measurement of Emitted Dose 3 weeks
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