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Study halted prematurely due to funding, prior to enrollment of first participant
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium bromide (Spiriva Respimat) | Experimental | Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat |
|
| Tiotropium bromide inhalation powder (Spiriva HandiHaler) | Active Comparator | Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tiotropium bromide inhalation powder (Spiriva HandiHaler) | Drug | Spiriva HandiHaler is a COPD medication that is available for use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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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
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| tiotropium bromide (Spiriva Respimat) | Drug | Spiriva Respimat is a COPD medication that is available for use. |
|
| Hyperpolarized 129XeMRI | Drug | Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved |
|
| 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 |
| 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 |
| 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 |
| 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |