Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients
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Status | Withdrawn |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 |
Verified date | June 2023 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Duke University |
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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