Pulmonary HypertensionPhase 2NCT00041574
Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide
A Phase 2 study testing Inhaled Nitric Oxide in people with Pulmonary Hypertension and Lung Disease, run by Mallinckrodt at 3 sites in United States.
Trial summary
The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Pulmonary Hypertension, Lung Disease, Sickle Cell Disease
- What is being tested?
- Inhaled Nitric Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2002to Dec 2005
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with pulmonary arterial hypertension (PAH) as defines by a mean pulmonary artery pressure (PAP) of 25 mmHg or greater by cardiac catheterization within the previous 12 months AND/OR Patients with chronic lung disease with severe impairment of gas exchange unresponsive to conventional medical management.
- If patient is receiving prostacyclin infusion treatment it must have been started at least one month prior to starting INO therapy. Patients will not be withdrawn from the study if started on other medications for treatment of pulmonary hypertension.
- Ability to establish a clinical investigator and a drug shipment site in the local area.
Who cannot join
- The Principal Investigator has determined that the patient and/or caregiver is/are unable to manage safe administration of home nitric oxide therapy and maintain appropriate drug accountability and storage.
- Women who are pregnant or nursing.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Children's Hospital
Denver, Colorado, 80262
University of Colorado Hospital
Denver, Colorado, 80262
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events.
Read the detailed description
This study will help develop a comprehensive home care program using INOmax delivery systems. This study will enroll a limited number of patients (5-7) from several disease categories in order to develop the experience with testing acute and chronic responsiveness to INO therapy. The following groups will be tested:
- Primary pulmonary hypertension (PPH)
- Severe pulmonary hypertension due to congenital (anatomic) heart disease
- Pulmonary hypertension or severe impairment of gas exchange in infants and children with chronic lung disease
- Pulmonary hypertension or severe impairment of gas exchange due to severe chronic lung disease in adults
- Pulmonary hypertension or severe impairment of gas exchange in hematologic and transplant disorders - young children and adults with sickle cell disease, chronic lung disease after bone marrow transplant, cardiac transplant, or lung transplant
- Conditions
- Pulmonary Hypertension, Lung Disease, Sickle Cell Disease, Cardiac Transplant, Lung Transplant
- Being tested
- Inhaled Nitric Oxide
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Nitric OxideDrug
Also called INOmax®
Inhaled Nitric Oxide will be delivered through the INOpulse® at a Low Dose Range (3mL to 10mL; in 1mL increments) and Ultra Low Dose Ranges (0.5mL to 4mL; 0.5mL, then 1 to 4mL in 1mL increments).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Inhaled Nitric Oxide will be delivered through the INOpulse® at a Low Dose Range (3mL to 10mL; in 1mL increments) and Ultra Low Dose Ranges (0.5mL to 4mL; 0.5mL, then 1 to 4mL in 1mL increments). Receives: Drug: Inhaled Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methemoglobin level
Measured: 24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months
Secondary outcomes (4)
Vital Signs
Measured: taken at 1, 2, 3, 4, 24, and 72 hours after treatment begins, then at 1, 3, 6, 9 and 12 months
Pulse Oximetry
Measured: taken at 1, 2, 3, 4, 24, and 72 hours after treatment start and then at 1, 3, 6, 9 and 12 months
Adverse Event Occurence
Measured: Study Duration
Echocardiogram
Measured: At 72 hours after treatment start, then at 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2002 (estimated)
- Study startApr 2002
- Primary completionDec 2005
- Study completionDec 2005
Why it stopped: Closed for lack of enrollment
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven H Abman, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041574
- Sponsor's protocol ID
- INOT-31
- Status last verified
- Sep 2016
- First submitted
- 10 Jul 2002
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
- ClinicalTrials.gov ID
- NCT00041574
- Acronym / sponsor ID
- INOT-31
- Conditions
- Pulmonary Hypertension, Lung Disease, Sickle Cell Disease, Cardiac Transplant, Lung Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed for lack of enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 11 Jul 2002 (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.
The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events.
Detailed description
This study will help develop a comprehensive home care program using INOmax delivery systems. This study will enroll a limited number of patients (5-7) from several disease categories in order to develop the experience with testing acute and chronic responsiveness to INO therapy. The following groups will be tested:
- Primary pulmonary hypertension (PPH)
- Severe pulmonary hypertension due to congenital (anatomic) heart disease
- Pulmonary hypertension or severe impairment of gas exchange in infants and children with chronic lung disease
- Pulmonary hypertension or severe impairment of gas exchange due to severe chronic lung disease in adults
- Pulmonary hypertension or severe impairment of gas exchange in hematologic and transplant disorders - young children and adults with sickle cell disease, chronic lung disease after bone marrow transplant, cardiac transplant, or lung transplant
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Inhaled Nitric OxideInhaled Nitric Oxide will be delivered through the INOpulse® at a Low Dose Range (3mL to 10mL; in 1mL increments) and Ultra Low Dose Ranges (0.5mL to 4mL; 0.5mL, then 1 to 4mL in 1mL increments). |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with pulmonary arterial hypertension (PAH) as defines by a mean pulmonary artery pressure (PAP) of 25 mmHg or greater by cardiac catheterization within the previous 12 months AND/OR Patients with chronic lung disease with severe impairment of gas exchange unresponsive to conventional medical management.
- If patient is receiving prostacyclin infusion treatment it must have been started at least one month prior to starting INO therapy. Patients will not be withdrawn from the study if started on other medications for treatment of pulmonary hypertension.
- Ability to establish a clinical investigator and a drug shipment site in the local area.
Key exclusion criteria (2 listed)
- The Principal Investigator has determined that the patient and/or caregiver is/are unable to manage safe administration of home nitric oxide therapy and maintain appropriate drug accountability and storage.
- Women who are pregnant or nursing.
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 Nitric OxideAlso: INOmax®Inhaled Nitric Oxide will be delivered through the INOpulse® at a Low Dose Range (3mL to 10mL; in 1mL increments) and Ultra Low Dose Ranges (0.5mL to 4mL; 0.5mL, then 1 to 4mL in 1mL increments). | Drug | 1 |
Primary outcome
Methemoglobin level
Time frame: 24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months
4 secondary outcomes
Vital Signs
Time frame: taken at 1, 2, 3, 4, 24, and 72 hours after treatment begins, then at 1, 3, 6, 9 and 12 months
Pulse Oximetry
Time frame: taken at 1, 2, 3, 4, 24, and 72 hours after treatment start and then at 1, 3, 6, 9 and 12 months
Adverse Event Occurence
Time frame: Study Duration
Echocardiogram
Time frame: At 72 hours after treatment start, then at 3, 6, 9 and 12 months
Results and safety
The study was stopped early (reason given: Closed for lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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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.
Steven H Abman, MD principal investigator
Children's Hospital Colorado
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 Inhaled Nitric Oxide in people with Pulmonary Hypertension and Lung Disease, run by Mallinckrodt 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 9 Sep 2016. 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?
The study was stopped early (reason given: Closed for lack of enrollment). Results are not available in the source record.
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?
Methemoglobin level (time frame: 24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months). 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 9 Sep 2016.