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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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