COPDPhase 1NCT06254664
Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule,Zephir Inhaler Device
A Phase 1 study testing Tiotropium 18 µg inhalation powder, hard capsule and Zephir inhaler in people with COPD, run by Xiromed LLC at 9 sites in 2 countries.
Trial summary
An Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule, Inhaler Device. Zephir inhaler robustness will be assessed by in vitro testing of the Zephir inhaler after 12 weeks of patient use Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- Tiotropium 18 µg inhalation powder, hard capsule and Zephir inhaler
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 3 Oct 2022to 27 Oct 2023
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of understanding the requirements, risks, and benefits of study participation, and as judged by the Investigator, capable of giving written informed consent.
- Male or non-pregnant female subjects between 40 to 75 years of age at Screening Visit (Visit 1) diagnosed with COPD.
- General good health (except the COPD diagnosis) and free of any concomitant conditions that would put the subject at increased risk during the study as per the discretion of the Investigator.
- An established physician diagnosis of COPD as defined by GOLD 2022.
- At Screening Visit, post-bronchodilator FEV1≤80% and ≥40% of predicted normal values as per Global Lung Function Initiative (GLI-2012) - and post-bronchodilator FEV1/FVC ratio ≤0.70.
- Current COPD Therapy: Subjects must be on stable regimens of one of the following for at least 8 weeks prior to screening (Visit 1):
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- Long-acting muscarinic antagonist (LAMA)
- LAMA+LABA
- Inhaled corticosteroids + LAMA
- Current or ex-smokers with ≥10 pack-year smoking history (Note: Pack- Year= (cigarettes smoked per day x years smoked)/20)).
- No occurrence of an upper or lower respiratory tract infection 14 days before Screening Visit.
- No COPD exacerbation, defined as any worsening of COPD requiring an emergency department visit or hospitalization, or the use of antibiotics (strong CYP450 3A4 inhibitors with ≥ 14 days of acute non-respiratory
- Ability to adequately use the Test inhaler.
Who cannot join
- Treatment for mild-moderate COPD exacerbations within 4 weeks prior to the Screening Visit (Visit 1) or more exacerbations in the last year.
- Hospitalization for COPD or pneumonia within 12 weeks prior to the Screening Visit (Visit 1).
- History of a life-threatening COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest, hypoxic seizures, or mMRC (Modified Medical Research Council) dyspnea Grade 4.
- Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 4 weeks prior to the Screening Visit (Visit 1).
- Subjects with a history of asthma or a clinical diagnosis of asthma, allergic rhinitis, or atopy; a total blood eosinophil count above 600/mm3.
- Historical or current evidence of a clinically significant disease
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- Have any of the following conditions that, in the judgment of the Investigator, might cause participation in this study to be detrimental to the subject.
- A subject must not have any clinically significant, uncontrolled condition, or disease state that, in the opinion of the Investigator, would put the safety of the subject at risk through study participation.
- History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or specific intolerance to aerosolized tiotropium-containing products or its derivatives.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Greater Providence Clinical Research, LLC
Cranston, Rhode Island, 02920
Inquest Clinical Research, LL
Cypress, Texas, 77433
Vanguard Clinical Research, LLC
Fort Myers, Florida, 33907
Clinical Research Solutions - Orlando
Kissimmee, Florida, 34744
Clintex Research Group
Miami, Florida, 33145
My Preferred Research LLC
Miami, Florida, 33155
Research Institute of South Florida, Inc.
Miami, Florida, 33173
Vista Health Research
Miami, Florida, 33176
About this study
Official title: Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule, Zephir Inhaler Device
An Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule, Inhaler Device. Zephir inhaler robustness will be assessed by in vitro testing of the Zephir inhaler after 12 weeks of patient use
- Conditions
- COPD
- Being tested
- Tiotropium 18 µg inhalation powder, hard capsule, Zephir inhaler
- 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 18 µg inhalation powder, hard capsuleDrug
Tiotropium 18 µg administered using Zephir inhaler
Zephir inhalerDevice
Tiotropium 18 µg administered using Zephir inhaler
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium 18 µg inhalation powder, hard capsule once daily (QD) | Experimental | Interventions:
Drug: Tiotropium 18 µg inhalation powder, hard capsule
Device: Zephir inhaler Receives: Drug: Tiotropium 18 µg inhalation powder, hard capsule; Device: Zephir inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vitro Measurement of Emitted Dose
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start3 Oct 2022
- Primary completion7 Jul 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiromed LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratorios Liconsa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254664
- Sponsor's protocol ID
- TioDPI PuR-01 (C2A02205)
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule, Zephir Inhaler Device
- ClinicalTrials.gov ID
- NCT06254664
- Acronym / sponsor ID
- TioDPI PuR-01 (C2A02205)
- Conditions
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Xiromed LLCIndustry (pharma, biotech, devices)
- Collaborators
- Laboratorios Liconsa
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 12 Feb 2024 (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.
An Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule, Inhaler Device. Zephir inhaler robustness will be assessed by in vitro testing of the Zephir inhaler after 12 weeks of patient use
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tiotropium 18 µg inhalation powder, hard capsule once daily (QD) | Experimental | Drug: Tiotropium 18 µg inhalation powder, hard capsule, Device: Zephir inhalerInterventions: Drug: Tiotropium 18 µg inhalation powder, hard capsule Device: Zephir inhaler |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Capable of understanding the requirements, risks, and benefits of study participation, and as judged by the Investigator, capable of giving written informed consent.
- Male or non-pregnant female subjects between 40 to 75 years of age at Screening Visit (Visit 1) diagnosed with COPD.
- General good health (except the COPD diagnosis) and free of any concomitant conditions that would put the subject at increased risk during the study as per the discretion of the Investigator.
- An established physician diagnosis of COPD as defined by GOLD 2022.
- At Screening Visit, post-bronchodilator FEV1≤80% and ≥40% of predicted normal values as per Global Lung Function Initiative (GLI-2012) - and post-bronchodilator FEV1/FVC ratio ≤0.70.
Key exclusion criteria (9 listed)
- Treatment for mild-moderate COPD exacerbations within 4 weeks prior to the Screening Visit (Visit 1) or more exacerbations in the last year.
- Hospitalization for COPD or pneumonia within 12 weeks prior to the Screening Visit (Visit 1).
- History of a life-threatening COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest, hypoxic seizures, or mMRC (Modified Medical Research Council) dyspnea Grade 4.
- Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 4 weeks prior to the Screening Visit (Visit 1).
- Subjects with a history of asthma or a clinical diagnosis of asthma, allergic rhinitis, or atopy; a total blood eosinophil count above 600/mm3.
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 18 µg inhalation powder, hard capsuleTiotropium 18 µg administered using Zephir inhaler | Drug | Tiotropium 18 µg inhalation powder, hard capsule once daily (QD) |
| Zephir inhalerTiotropium 18 µg administered using Zephir inhaler | Device | Tiotropium 18 µg inhalation powder, hard capsule once daily (QD) |
Primary outcome
In vitro Measurement of Emitted Dose
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tiotropium 18 µg inhalation powder, hard capsule and Zephir inhaler in people with COPD, run by Xiromed LLC at 9 sites in 2 countries.
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 13 inclusion and 9 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: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In vitro Measurement of Emitted Dose (time frame: 3 weeks). 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 12 Feb 2024.