Pulmonary HypertensionPhase 1TAPIT-1NCT01758744
Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1
A Phase 1 study testing Inhaled Treprostinil Therapy in people with Pulmonary Hypertension and COPD, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
An Open Label, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Pulmonary Hypertension, COPD
- What is being tested?
- Inhaled Treprostinil Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Jul 2016
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be between the ages of 30 and 80
- have a clinical diagnosis of Gold stage 2 to 4 COPD
- have a diagnosis of pulmonary hypertension established by a historic right heart catheterization
- a minimum weight of 45 Kg
- minimum systolic blood pressure of >90 mmHg
- be able to perform a six minute walk test
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- be able to maintain a oxygen saturation >88% at rest (with or without oxygen)
- be treated with background therapy for COPD for a minimum of 1 month prior to consideration of enrollment.
- be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form and must sign the form prior to the initiation of any study procedure.
Who cannot join
- The presence of pulmonary venous hypertension defined by a historical right heart catheterization
- Gold Stage I COPD
- documented left ventricular dysfunction as measured by echocardiography
- pregnant or breastfeeding
- Recipient of a lung transplant
- received chronic prostanoid therapy for pulmonary hypertension within 4 weeks prior to the screening appointment
- A requirement of greater than 9 l/min of O2 to maintain oxygen saturations greater than 88% at rest
- No other serious medical conditions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver
Aurora, Colorado, 80045
University of Florida College of Medicine
Jacksonville, Florida, 32209
About this study
Official title: TAPIT-1: Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1
An Open Label, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD)
Read the detailed description
This is a pilot study of 10 patients that have COPD-PH. Primary outcome measure is to see if this drug is safe for this patient population and the secondary measure is to see if the drug improves patient functional capacity.
- Conditions
- Pulmonary Hypertension, COPD
- Being tested
- Inhaled Treprostinil Therapy
- Keywords
- COPD PH, COPD associated Pulmonary Hypertension, COPD and Pulmonary Hypertension, Disease
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Treprostinil TherapyDrug
Also called Tyvaso ®
Treprostinil: Inhaled prostanoid therapy
| Study group | Role | What they receive |
|---|---|---|
| Treprostinil | Experimental | Inhaled prostanoid therapy with Treprostinil Receives: Drug: Inhaled Treprostinil Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1).
A 4-Week, Open Label Study Testing the Safety of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Lung Disease (COPD) (PH-COPD)
Measured: This is a 4 week trial
Secondary outcomes (5)
New York Heart Association (NYHA) functional class
A change in functional class is assessed as improvement or deterioration in the patient's functional status
Measured: Change in New York Heart Association (NYHA) functional class assessed at baseline and at week 4.
Six minute walk distance
A change in how far the subject can walk in 6 minutes will be measured at baseline and compared to how far the subject can walk in 6 minutes at week 4.
Measured: Change from baseline in 6 minute walk distance at 4 weeks
Clinical Worsening
Clinical worsening is described as Death, hospitalization (all cause)and COPD exacerbations (worsening of respiratory symptoms which require treatment with oral corticosteroids, antibiotics or both).
Measured: From the time of randomization to until the subject discontinues from study for any cause, assessed up to 4 weeks
Peripheral Blood Mononuclear Cells (PBMC) phagocytic index (PI) and PBMC gene expression
The phagocytic index is the average number of bacteria ingested per phagocyte in an incubated mixture of bacteria, phagocytes, and blood serum. We will also be looking a a change in gene expression of these (PBMC) cells.
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Measured: Change from baseline in PBMC PI and PBMC gene expression at 4 weeks
St. George's Chronic Obstructive Pulmonary Disease (COPD) questionnaire
The St. George's questionnaire is a quality of life questionnaire completed by the subject at baseline and at week 4.
Measured: change from baseline in the St. George's respiratory questionnaire at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd M. Bull, M.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758744
- Sponsor's protocol ID
- 12-0560
- Acronym
- TAPIT-1
- Status last verified
- Jul 2016
- First submitted
- 6 Dec 2012
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAPIT-1: Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1
- ClinicalTrials.gov ID
- NCT01758744
- Acronym / sponsor ID
- TAPIT-1 / 12-0560
- Conditions
- Pulmonary Hypertension, COPD
- Keywords
- COPD PH, COPD associated Pulmonary Hypertension, COPD and Pulmonary Hypertension, Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Jan 2013 (estimated)
- 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, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD)
Detailed description
This is a pilot study of 10 patients that have COPD-PH. Primary outcome measure is to see if this drug is safe for this patient population and the secondary measure is to see if the drug improves patient functional capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treprostinil | Experimental | Drug: Inhaled Treprostinil TherapyInhaled prostanoid therapy with Treprostinil |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be between the ages of 30 and 80
- have a clinical diagnosis of Gold stage 2 to 4 COPD
- have a diagnosis of pulmonary hypertension established by a historic right heart catheterization
- a minimum weight of 45 Kg
- minimum systolic blood pressure of >90 mmHg
Key exclusion criteria (8 listed)
- The presence of pulmonary venous hypertension defined by a historical right heart catheterization
- Gold Stage I COPD
- documented left ventricular dysfunction as measured by echocardiography
- pregnant or breastfeeding
- Recipient of a lung transplant
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 |
|---|---|---|
| Inhaled Treprostinil TherapyAlso: Tyvaso ®Treprostinil: Inhaled prostanoid therapy | Drug | Treprostinil |
Primary outcome
To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1).
Time frame: This is a 4 week trial
A 4-Week, Open Label Study Testing the Safety of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Lung Disease (COPD) (PH-COPD)
5 secondary outcomes
New York Heart Association (NYHA) functional class
Time frame: Change in New York Heart Association (NYHA) functional class assessed at baseline and at week 4.
Six minute walk distance
Time frame: Change from baseline in 6 minute walk distance at 4 weeks
Clinical Worsening
Time frame: From the time of randomization to until the subject discontinues from study for any cause, assessed up to 4 weeks
Peripheral Blood Mononuclear Cells (PBMC) phagocytic index (PI) and PBMC gene expression
Time frame: Change from baseline in PBMC PI and PBMC gene expression at 4 weeks
St. George's Chronic Obstructive Pulmonary Disease (COPD) questionnaire
Time frame: change from baseline in the St. George's respiratory questionnaire at 4 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 20 Jul 2016.
Related trials for Pulmonary Hypertension
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.
Todd M. Bull, M.D. principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inhaled Treprostinil Therapy in people with Pulmonary Hypertension and COPD, run by University of Colorado, Denver at 2 sites in United States.
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 9 inclusion and 8 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 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1). (time frame: This is a 4 week trial). 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 20 Jul 2016.