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

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

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: Tiotropium 18 µg inhalation powder, hard capsule; Device: Zephir inhaler

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 382210
      • Cliantha Research
• United States
  • Florida
    • Fort Myers, Florida, United States, 33907
      • Vanguard Clinical Research, LLC
    • Kissimmee, Florida, United States, 34744
      • Clinical Research Solutions - Orlando
    • Miami, Florida, United States, 33176
      • Vista Health Research
    • Miami, Florida, United States, 33173
      • Research Institute of South Florida, Inc.
    • Miami, Florida, United States, 33145
      • Clintex Research Group
    • Miami, Florida, United States, 33155
      • My Preferred Research LLC
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • Greater Providence Clinical Research, LLC
  • Texas
    • Cypress, Texas, United States, 77433
      • Inquest Clinical Research, LL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tiotropium 18 µg inhalation powder, hard capsule once daily (QD); Interventions: Drug: Tiotropium 18 µg inhalation powder, hard capsule Device: Zephir inhaler	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In vitro Measurement of Emitted Dose	3 weeks

Collaborators and Investigators

• Sponsor: Xiromed LLC
• Collaborators: Laboratorios Liconsa

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: TioDPI PuR-01 (C2A02205)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No