Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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
See also
  Status Clinical Trial Phase
Completed NCT03282019 - Study of Long-term HFNC for COPD Patients With HOT N/A
Completed NCT05573464 - A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With the Hydrofluoroolefin Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease Phase 3
Recruiting NCT06040086 - Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations Phase 3
Not yet recruiting NCT06376994 - Multi-Center Clean Air Randomized Controlled Trial in COPD Phase 3
Completed NCT02797392 - Feasibility of a Preventive Program Against Lifestyle Related Diseases N/A
Completed NCT02728674 - Management of Patients With Respiratory Symptoms in Sweden N/A
Completed NCT02926534 - Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan N/A
Recruiting NCT02415478 - Bronchioscopic Lung Volume Reduction (BLVR) N/A
Completed NCT03487406 - Anti-platelet Therapy in the Prevention of Cardiovascular Disease in Patients With COPD (APPLE-COPD: ICON 2) Phase 2
Completed NCT02518139 - A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT02459080 - Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT02774226 - Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02512510 - Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT01908140 - Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01893476 - A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management N/A
Withdrawn NCT01908933 - Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema Phase 3
Completed NCT01701869 - Microbiology & Immunology of the Chronically-inflamed Airway N/A
Recruiting NCT02527486 - Seoul National University Airway Registry N/A
Withdrawn NCT01377428 - Efficacy of Indacaterol 150 µg Versus Formoterol Phase 4