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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05838703
Other study ID # Pro00112737
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date May 1, 2023
Est. completion date May 1, 2024

Study information

Verified date June 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
tiotropium bromide inhalation powder (Spiriva HandiHaler)
Spiriva HandiHaler is a COPD medication that is available for use.
tiotropium bromide (Spiriva Respimat)
Spiriva Respimat is a COPD medication that is available for use.
Hyperpolarized 129XeMRI
Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 visit, up to 4 hours
Primary 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 1 visit, up to 4 hours
Primary 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 1 visit, up to 4 hours
Primary Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler Perform Pre- and Post-Spirometry to examine the changes in FEV1 1 visit, up to 4 hours
Primary Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler Perform Pre- and Post-Spirometry to examine the changes in FVC 1 visit, up to 4 hours
Primary 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 1 visit, up to 4 hours
Primary 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 1 visit, up to 4 hours
Primary Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat Perform Pre- and Post-Spirometry to examine the changes in FEV1 1 visit, up to 4 hours
Primary Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat Perform Pre- and Post-Spirometry to examine the changes in FVC 1 visit, up to 4 hours
Primary 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 1 visit, up to 4 hours
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