Tiotropium Handihaler vs. Tiotropium Respimat in COPD

NCT05838703 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: Pro00112737
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (10)

• 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

• 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

Study Arms (2)

Tiotropium bromide (Spiriva Respimat)

EXPERIMENTAL

Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat

Drug: tiotropium bromide (Spiriva Respimat); Drug: Hyperpolarized 129XeMRI

Tiotropium bromide inhalation powder (Spiriva HandiHaler)

ACTIVE COMPARATOR

Images obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler

Drug: tiotropium bromide inhalation powder (Spiriva HandiHaler); Drug: Hyperpolarized 129XeMRI

Interventions

tiotropium bromide inhalation powder (Spiriva HandiHaler) DRUG

Spiriva HandiHaler is a COPD medication that is available for use.

Tiotropium bromide inhalation powder (Spiriva HandiHaler)

tiotropium bromide (Spiriva Respimat) DRUG

Spiriva Respimat is a COPD medication that is available for use.

Tiotropium bromide (Spiriva Respimat)

Hyperpolarized 129XeMRI DRUG

Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved

Tiotropium bromide (Spiriva Respimat); Tiotropium bromide inhalation powder (Spiriva HandiHaler)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Upper respiratory tract infection within 6 weeks (in this case, we will re-screen the patient after 6 weeks)
• /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

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: May 1, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06