Tiotropium Handihaler vs. Tiotropium Respimat in COPD

June 13, 2023 updated by: Yuh Chin T Huang, MD, MHS, Duke University

Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Outpatients of either gender, age > 40.
  2. Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed)
  3. Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol.
  4. Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating FEV1/FVC < 0.70 in all GOLD stages (http://www.goldcopd.org/).

  5. Patients who are tiotropium naïve or whose tiotropium can be withheld for 2 weeks before screening visit/visit 1

    Exclusion Criteria:

  6. Upper respiratory tract infection within 6 weeks (in this case, we will re-screen the patient after 6 weeks)
  7. 24/7 oxygen use
  8. Previous history of pneumothorax
  9. Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies
  10. For women of child bearing potential, positive pregnancy test.
  11. Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study
  12. History of claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tiotropium bromide (Spiriva Respimat)
Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat
Drug: tiotropium bromide (Spiriva Respimat)
Spiriva Respimat is a COPD medication that is available for use.
Drug: Hyperpolarized 129XeMRI
Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved
Active Comparator: Tiotropium bromide inhalation powder (Spiriva HandiHaler)
Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler
Drug: Hyperpolarized 129XeMRI
Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved
Drug: tiotropium bromide inhalation powder (Spiriva HandiHaler)
Spiriva HandiHaler is a COPD medication that is available for use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler
Time Frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry with Spiriva HandiHaler to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva HandiHaler
1 visit, up to 4 hours
Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking patient while taking Spiriva Respimat
Time Frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry with Spiriva Respimat to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva Respimat
1 visit, up to 4 hours
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
Time Frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC
1 visit, up to 4 hours
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
Time Frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEV1
1 visit, up to 4 hours
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
Time Frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FVC
1 visit, up to 4 hours
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
Time Frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEF25-75
1 visit, up to 4 hours
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
Time Frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC
1 visit, up to 4 hours
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
Time Frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEV1
1 visit, up to 4 hours
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
Time Frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FVC
1 visit, up to 4 hours
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
Time Frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEF25-75
1 visit, up to 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00112737

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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