Pulmonary Arterial HypertensionPhase 2PILOTNCT01092559
Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide
A Phase 2 study testing Nitric Oxide generated by the GeNO nitrosyl delivery system in people with Pulmonary Arterial Hypertension, run by Geno LLC at 3 sites in United States.
Trial summary
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial hypertension (PAH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Nitric Oxide generated by the GeNO nitrosyl delivery system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2010to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a confirmed diagnosis of PAH, WHO Group 1.
- WHO Functional Class II or III equivalent, PAH.
- Have been clinically stable with regard to signs and symptoms of PAH for at least 30 days prior to RHC.
- May be receiving approved mono therapies or combination PAH therapies.
- Females that are surgically sterile or post-menopausal. Females of chil-bearing potential must have negative pregnancy test and must be practicing adequate birth control.
Who cannot join
- Have had a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin) for PAH added within (1) month of RHC.
- Have any PAH medication except for anticoagulants discontinued within the week prior to RHC.
- Have evidence of significant parenchymal lung disease as evidenced by pulmonary function tests within the last six months
- CREST (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, telangiectasia) syndrome
- Have a history of uncontrolled sleep apnea within three months of RHC.
- Have a history of hemodynamically significant left-sided heart disease
Show all 18Show fewer
- Have evidence of left-sided heart disease
- Have any other disease that is associated with pulmonary hypertension (e.g. congenital systemic-to-pulmonary shunt, sickle cell anemia, schistosomiasis).
- Documented uncontrolled systemic hypertension as evidenced by systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
- Have used prescription appetite suppressants within 3 months prior to wean/transition.
- Have chronic kidney disease stage IV or worse or the requirement for dialysis.
- Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
- Have had an atrial septostomy.
- Have anemia (hemoglobin <10 g/dL), active infection or any other ongoing condition that would interfere with the interpretation of study assessments.
- Have any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, renal dialysis, etc.).
- Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial
- Participant is pregnant or lactating
- Significant, ongoing alcohol or drug abuse.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tufts
Boston, Massachusetts, 02111
University Hospital
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: An Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery System
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial hypertension (PAH). All participants will receive inhaled nitric oxide in oxygen or nitric oxide in air delivered by nasal cannula. Hemodynamics, clinical laboratory and clinical assessment data will be collected on all participants to evaluate safety.
Read the detailed description
TREATMENT/FOLLOW-UP:
Participants meeting eligibility criteria will receive open label nitric oxide at 80 ppm via a nasal cannula. Hemodynamic clinical laboratory and clinical assessment data will be collected at baseline, after 15 minutes of inhaled nitric oxide administration, post RHC procedure and at hospital discharge. Day 5 +/- 3 post RHC, telephone contact to assess general health status.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Nitric Oxide generated by the GeNO nitrosyl delivery system
- Keywords
- Diagnostic Techniques and Procedures
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide generated by the GeNO nitrosyl delivery systemDrug
single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
| Study group | Role | What they receive |
|---|---|---|
| nitric oxide via GeNO Nitrosyl system | Experimental | Nitric Oxide via GeNO Nitrosyl system Receives: Drug: Nitric Oxide generated by the GeNO nitrosyl delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs.
Adverse Event Severity [through Day 30 Follow-Up Period]
Unanticipated Device Effects: any system malfunction, damage or NO2 threshold monitor alarms [through discharge from Treatment Period]
Laboratory Tests: Hematology (CBC with differential), Chemistry (glucose, BUN, creatinine, sodium, potassium, carbon dioxide, creatinine kinase), Activated Clotting Test or Prothrombin Time, arterial blood gas, and methemoglobin.
[through discharge from Treatment Period]
Vital Signs: pulse, blood pressure, respiratory rate [through discharge from Treatment Period]
Measured: through Day 30 Follow-up Period
Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation
Measured: through Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geno LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092559
- Sponsor's protocol ID
- P2010-001
- Acronym
- PILOT
- Status last verified
- Apr 2013
- First submitted
- 16 Feb 2010
- Last updated
- 4 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery System
- ClinicalTrials.gov ID
- NCT01092559
- Acronym / sponsor ID
- PILOT / P2010-001
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Diagnostic Techniques and Procedures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Geno LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Posted 4 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial hypertension (PAH). All participants will receive inhaled nitric oxide in oxygen or nitric oxide in air delivered by nasal cannula. Hemodynamics, clinical laboratory and clinical assessment data will be collected on all participants to evaluate safety.
Detailed description
TREATMENT/FOLLOW-UP:
Participants meeting eligibility criteria will receive open label nitric oxide at 80 ppm via a nasal cannula. Hemodynamic clinical laboratory and clinical assessment data will be collected at baseline, after 15 minutes of inhaled nitric oxide administration, post RHC procedure and at hospital discharge. Day 5 +/- 3 post RHC, telephone contact to assess general health status.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nitric oxide via GeNO Nitrosyl system | Experimental | Drug: Nitric Oxide generated by the GeNO nitrosyl delivery systemNitric Oxide via GeNO Nitrosyl system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a confirmed diagnosis of PAH, WHO Group 1.
- WHO Functional Class II or III equivalent, PAH.
- Have been clinically stable with regard to signs and symptoms of PAH for at least 30 days prior to RHC.
- May be receiving approved mono therapies or combination PAH therapies.
- Females that are surgically sterile or post-menopausal. Females of chil-bearing potential must have negative pregnancy test and must be practicing adequate birth control.
Key exclusion criteria (18 listed)
- Have had a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin) for PAH added within (1) month of RHC.
- Have any PAH medication except for anticoagulants discontinued within the week prior to RHC.
- Have evidence of significant parenchymal lung disease as evidenced by pulmonary function tests within the last six months
- CREST (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, telangiectasia) syndrome
- Have a history of uncontrolled sleep apnea within three months of RHC.
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 |
|---|---|---|
| Nitric Oxide generated by the GeNO nitrosyl delivery systemsingle short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system. | Drug | nitric oxide via GeNO Nitrosyl system |
Primary outcome
Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs.
Time frame: through Day 30 Follow-up Period
Adverse Event Severity [through Day 30 Follow-Up Period] Unanticipated Device Effects: any system malfunction, damage or NO2 threshold monitor alarms [through discharge from Treatment Period] Laboratory Tests: Hematology (CBC with differential), Chemistry (glucose, BUN, creatinine, sodium, potassium, carbon dioxide, creatinine kinase), Activated Clotting Test or Prothrombin Time, arterial blood gas, and methemoglobin. [through discharge from Treatment Period] Vital Signs: pulse, blood pressure, respiratory rate [through discharge from Treatment Period]
Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation
Time frame: through Treatment Period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide generated by the GeNO nitrosyl delivery system in people with Pulmonary Arterial Hypertension, run by Geno LLC at 3 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 5 inclusion and 18 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 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Yes. Results are posted in the registry (first posted 4 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs. (time frame: through Day 30 Follow-up Period). The study lists 2 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 4 Jun 2013.