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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06254664
• Other study ID #: TioDPI PuR-01 (C2A02205)
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• COPD
• Respiratory Aspiration

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