Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT05838703
Tiotropium Handihaler vs. Tiotropium Respimat in COPD
A Phase 2 study testing tiotropium bromide inhalation powder (Spiriva HandiHaler), tiotropium bromide (Spiriva Respimat) and Hyperpolarized 129XeMRI in people with Chronic Obstructive Pulmonary Disease (COPD), run by Duke University.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- tiotropium bromide inhalation powder (Spiriva HandiHaler), tiotropium bromide (Spiriva Respimat) and Hyperpolarized 129XeMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients
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.
- Being tested
- tiotropium bromide inhalation powder (Spiriva HandiHaler), tiotropium bromide (Spiriva Respimat), Hyperpolarized 129XeMRI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiotropium bromide inhalation powder (Spiriva HandiHaler)Drug
Spiriva HandiHaler is a COPD medication that is available for use.
tiotropium bromide (Spiriva Respimat)Drug
Spiriva Respimat is a COPD medication that is available for use.
Hyperpolarized 129XeMRIDrug
Xe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium bromide (Spiriva Respimat) | Experimental | Images obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat Receives: 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 Receives: Drug: tiotropium bromide inhalation powder (Spiriva HandiHaler); Drug: Hyperpolarized 129XeMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 visit, up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Why it stopped: Study halted prematurely due to funding, prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuh Chin T Huang, MD, MHS, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838703
- Sponsor's protocol ID
- Pro00112737
- Status last verified
- Jun 2023
- First submitted
- 24 Mar 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Acute Effects of Tiotropium Handihaler With Tiotropium Respimat on the Ventilation Distribution in COPD Patients
- ClinicalTrials.gov ID
- NCT05838703
- Acronym / sponsor ID
- Pro00112737
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely due to funding, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiotropium bromide (Spiriva Respimat) | Experimental | Drug: tiotropium bromide (Spiriva Respimat), Drug: Hyperpolarized 129XeMRIImages obtained using 129XeMRI will be obtained after one-time use of Spiriva Respimat |
| Tiotropium bromide inhalation powder (Spiriva HandiHaler) | Active comparator | Drug: tiotropium bromide inhalation powder (Spiriva HandiHaler), Drug: Hyperpolarized 129XeMRIImages obtained using 129XeMRI will be obtained after one-time use of Spiriva HandiHaler |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tiotropium bromide inhalation powder (Spiriva HandiHaler)Spiriva HandiHaler is a COPD medication that is available for use. | Drug | Tiotropium bromide inhalation powder (Spiriva HandiHaler) |
| tiotropium bromide (Spiriva Respimat)Spiriva Respimat is a COPD medication that is available for use. | Drug | Tiotropium bromide (Spiriva Respimat) |
| Hyperpolarized 129XeMRIXe129 hyperpolarized with use of MRI for evaluation of lung ventilation has recently been FDA approved | Drug | Tiotropium bromide (Spiriva Respimat), Tiotropium bromide inhalation powder (Spiriva HandiHaler) |
Primary outcome
Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler
Time frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry with Spiriva HandiHaler to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva HandiHaler
Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking patient while taking Spiriva Respimat
Time frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry with Spiriva Respimat to assess the ventilation distribution percentage in patients (no ventilation/total ventilation) while taking Spiriva Respimat
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
Time frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
Time frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEV1
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
Time frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FVC
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva HandiHaler
Time frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEF25-75
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
Time frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEV1/FVC
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
Time frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEV1
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
Time frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FVC
Assess the changes in Pre- and Post-Spirometry procedure while on Spiriva Respimat
Time frame: 1 visit, up to 4 hours
Perform Pre- and Post-Spirometry to examine the changes in FEF25-75
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tiotropium bromide inhalation powder (Spiriva HandiHaler), tiotropium bromide (Spiriva Respimat) and Hyperpolarized 129XeMRI in people with Chronic Obstructive Pulmonary Disease (COPD), run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the change in ventilation distribution parameters by 129Xe MRI in patient while taking Spiriva HandiHaler (time frame: 1 visit, up to 4 hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.