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Tiotropium Handihaler vs. Tiotropium Respimat in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
tiotropium bromide inhalation powder (Spiriva HandiHaler)
tiotropium bromide (Spiriva Respimat)
Hyperpolarized 129XeMRI
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Outpatients of either gender, age > 40. Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed) Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol. Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating FEV1/FVC < 0.70 in all GOLD stages (http://www.goldcopd.org/). Patients who are tiotropium naïve or whose tiotropium can be withheld for 2 weeks before screening visit/visit 1 Exclusion Criteria: Upper respiratory tract infection within 6 weeks (in this case, we will re-screen the patient after 6 weeks) 24/7 oxygen use Previous history of pneumothorax Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies For women of child bearing potential, positive pregnancy test. Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study History of claustrophobia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tiotropium bromide (Spiriva Respimat)

    Tiotropium bromide inhalation powder (Spiriva HandiHaler)

    Arm Description

    Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat

    Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler

    Outcomes

    Primary Outcome Measures

    Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler
    Perform Pre- and Post-Spirometry with Spiriva HandiHaler to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva HandiHaler
    Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking patient while taking Spiriva Respimat
    Perform Pre- and Post-Spirometry with Spiriva Respimat to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva Respimat
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
    Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
    Perform Pre- and Post-Spirometry to examine the changes in FEV1
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
    Perform Pre- and Post-Spirometry to examine the changes in FVC
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
    Perform Pre- and Post-Spirometry to examine the changes in FEF25-75
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
    Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
    Perform Pre- and Post-Spirometry to examine the changes in FEV1
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
    Perform Pre- and Post-Spirometry to examine the changes in FVC
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
    Perform Pre- and Post-Spirometry to examine the changes in FEF25-75

    Secondary Outcome Measures

    Full Information

    First Posted
    March 24, 2023
    Last Updated
    June 13, 2023
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05838703
    Brief Title
    Tiotropium Handihaler vs. Tiotropium Respimat in COPD
    Official Title
    Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study halted prematurely due to funding, prior to enrollment of first participant
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    May 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Duke University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if tiotropium Respimat will result in better ventilation distribution of the lung in COPD participants quantified by hyperpolarized XeMRI. This study is designed to simulate the real-life clinical setting where patients receive one-time instruction on the inhaler use.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease (COPD)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tiotropium bromide (Spiriva Respimat)
    Arm Type
    Experimental
    Arm Description
    Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat
    Arm Title
    Tiotropium bromide inhalation powder (Spiriva HandiHaler)
    Arm Type
    Active Comparator
    Arm Description
    Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler
    Intervention Type
    Drug
    Intervention Name(s)
    tiotropium bromide inhalation powder (Spiriva HandiHaler)
    Intervention Description
    Spiriva HandiHaler is a COPD medication that is available for use.
    Intervention Type
    Drug
    Intervention Name(s)
    tiotropium bromide (Spiriva Respimat)
    Intervention Description
    Spiriva Respimat is a COPD medication that is available for use.
    Intervention Type
    Drug
    Intervention Name(s)
    Hyperpolarized 129XeMRI
    Intervention Description
    Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved
    Primary Outcome Measure Information:
    Title
    Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler
    Description
    Perform Pre- and Post-Spirometry with Spiriva HandiHaler to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva HandiHaler
    Time Frame
    1 visit, up to 4 hours
    Title
    Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking patient while taking Spiriva Respimat
    Description
    Perform Pre- and Post-Spirometry with Spiriva Respimat to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva Respimat
    Time Frame
    1 visit, up to 4 hours
    Title
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
    Description
    Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC
    Time Frame
    1 visit, up to 4 hours
    Title
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
    Description
    Perform Pre- and Post-Spirometry to examine the changes in FEV1
    Time Frame
    1 visit, up to 4 hours
    Title
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
    Description
    Perform Pre- and Post-Spirometry to examine the changes in FVC
    Time Frame
    1 visit, up to 4 hours
    Title
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
    Description
    Perform Pre- and Post-Spirometry to examine the changes in FEF25-75
    Time Frame
    1 visit, up to 4 hours
    Title
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
    Description
    Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC
    Time Frame
    1 visit, up to 4 hours
    Title
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
    Description
    Perform Pre- and Post-Spirometry to examine the changes in FEV1
    Time Frame
    1 visit, up to 4 hours
    Title
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
    Description
    Perform Pre- and Post-Spirometry to examine the changes in FVC
    Time Frame
    1 visit, up to 4 hours
    Title
    Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
    Description
    Perform Pre- and Post-Spirometry to examine the changes in FEF25-75
    Time Frame
    1 visit, up to 4 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Outpatients of either gender, age > 40. Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed) Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol. Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating FEV1/FVC < 0.70 in all GOLD stages (http://www.goldcopd.org/). Patients who are tiotropium naïve or whose tiotropium can be withheld for 2 weeks before screening visit/visit 1 Exclusion Criteria: Upper respiratory tract infection within 6 weeks (in this case, we will re-screen the patient after 6 weeks) 24/7 oxygen use Previous history of pneumothorax Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies For women of child bearing potential, positive pregnancy test. Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study History of claustrophobia

    12. IPD Sharing Statement

    Learn more about this trial

    Tiotropium Handihaler vs. Tiotropium Respimat in COPD

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