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

NCT06254664 | Completed Phase 1 FDA Drug

• 1 other identifier: TioDPI PuR-01 (C2A02205)
• Study Type: interventional
• Target: 116
• Locations: 2 countries
• Sites: 9

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

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• In vitro Measurement of Emitted Dose

  3 weeks

Study Arms (1)

Tiotropium 18 µg inhalation powder, hard capsule once daily (QD)

EXPERIMENTAL

Interventions: Drug: Tiotropium 18 µg inhalation powder, hard capsule Device: Zephir inhaler

Drug: Tiotropium 18 µg inhalation powder, hard capsule; Device: Zephir inhaler

Interventions

Tiotropium 18 µg inhalation powder, hard capsule DRUG

Tiotropium 18 µg administered using Zephir inhaler

Tiotropium 18 µg inhalation powder, hard capsule once daily (QD)

Zephir inhaler DEVICE

Tiotropium 18 µg administered using Zephir inhaler

Tiotropium 18 µg inhalation powder, hard capsule once daily (QD)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of understanding the requirements, risks, and benefits of study participation, and as judged by the Investigator, capable of giving written informed consent.
• Male or non-pregnant female subjects between 40 to 75 years of age at Screening Visit (Visit 1) diagnosed with COPD.
• 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.
• An established physician diagnosis of COPD as defined by GOLD 2022.
• 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.
• 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
• Current or ex-smokers with ≥10 pack-year smoking history (Note: Pack- Year= (cigarettes smoked per day x years smoked)/20)).
• No occurrence of an upper or lower respiratory tract infection 14 days before Screening Visit.
• 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
• Ability to adequately use the Test inhaler.

You may not qualify if:

• Treatment for mild-moderate COPD exacerbations within 4 weeks prior to the Screening Visit (Visit 1) or more exacerbations in the last year.
• Hospitalization for COPD or pneumonia within 12 weeks prior to the Screening Visit (Visit 1).
• 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.
• 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).
• Subjects with a history of asthma or a clinical diagnosis of asthma, allergic rhinitis, or atopy; a total blood eosinophil count above 600/mm3.
• Historical or current evidence of a clinically significant disease
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Xiromed LLC: lead
• Laboratorios Liconsa: collaborator

Study Sites (9)

Vanguard Clinical Research, LLC

Fort Myers, Florida, 33907, United States

Location

Clinical Research Solutions - Orlando

Kissimmee, Florida, 34744, United States

Location

Clintex Research Group

Miami, Florida, 33145, United States

Location

My Preferred Research LLC

Miami, Florida, 33155, United States

Location

Research Institute of South Florida, Inc.

Miami, Florida, 33173, United States

Location

Vista Health Research

Miami, Florida, 33176, United States

Location

Greater Providence Clinical Research, LLC

Cranston, Rhode Island, 02920, United States

Location

Inquest Clinical Research, LL

Cypress, Texas, 77433, United States

Location

Cliantha Research

Ahmedabad, Gujarat, 382210, India

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Hardness

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Mechanical Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 12, 2024
• Study Start: October 3, 2022
• Primary Completion: July 7, 2023
• Study Completion: October 27, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

IN (1); US (8)