Pulmonary HypertensionPhase 1NCT02267655
3 Part Study to Assess Inhaled Nitric Oxide on Functional Pulmonary Imaging in Subj. Pulmonary Hypertension Associated w/ COPD and IPF
A Phase 1 study testing inhaled Nitric Oxide - 30 mcg/kg IBW/hr, inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr and inhaled nitric oxide 75 mcg/kg IBW/hr in people with Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by Bellerophon at 1 site in Belgium.
Trial summary
The objective of this exploratory study is to examine the utility of high resolution computed tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function of short term a) iNO administration and b) nitric oxide (NO) cylinder concentration using the investigational medical device… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis
- What is being tested?
- inhaled Nitric Oxide - 30 mcg/kg IBW/hr, inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr and inhaled nitric oxide 75 mcg/kg IBW/hr
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- May 2015to 28 Jun 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be enrolled and eligible to participate in the study:
- A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria
- Pulmonary hypertension determined by one of the following within the past 12 months:
- A right heart catheterization (not obtained within ± 7 days of an exacerbation) with an mPAP ≥ 25 mmHg, or
- An echocardiogram (not obtained within ± 7 days of an exacerbation) with a TRV ≥ 2.9 m/s or sPAP ≥ 38 mmHg (Note: a subject with an acceptable mPAP ≥ 25 mmHg determined by right heart catheterization will meet this inclusion criteria even with a TRV < 2.9 m/s)
- Current or former smokers with at least 10 pack-years of tobacco cigarette smoking before study entry
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- Age ≥ 40 years, ≤ 80 years
- A post-bronchodilatory FEV1/FVC < 0.7 and a FEV1 < 60% predicted (values obtained within 6 months prior to screening can be used unless obtained within ± 7 days of an exacerbation; otherwise, the test must be performed during screening)
- Receiving LTOT for ≥ 3 months and ≥ 10 hours per day as determined by history
- Females of childbearing potential must have a negative pre-treatment urine pregnancy test
- Signed informed consent prior to the initiation of any study mandated procedures or assessments
Who cannot join
- Subjects who meet any of the following criteria are not eligible for enrollment:
- A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator
- Lack of patency of nares upon physical examination
- Experienced during the last month an exacerbation requiring:
- start of or increase in systemic oral corticosteroid therapy and/or
- hospitalization
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- Left ventricular dysfunction as measured by:
- Screening echocardiographic evidence of left ventricular systolic dysfunction (left ventricular ejection fraction [LVEF] < 40%), or
- Screening echocardiographic evidence of left ventricular diastolic dysfunction
- > moderate (i.e., > Grade 2), or
- Any history of pulmonary capillary wedge pressure (PCWP), left atrial pressure (LAP) or left ventricular end diastolic pressure (LVEDP) > 18 mmHg as measured during cardiac catheterization within the past 6 months unless documented to have resolved by a subsequent cardiac catheterization
- Renal impairment (i.e., an estimated GFRMDRD < 60 ml/min/1.73 m2) or history of renal failure using the equation (Levey et al., 2007):
- estimated GFRMDRD = 175×Scr -1.154×Age-0.203 ×1.212 (if black) ×0.742 (if female)
- where Scr = Standardized serum creatinine
- Known allergy to contrast media.
- Clinically significant valvular heart disease that may contribute to PH, including mild or greater aortic valvular disease (aortic stenosis or regurgitation) and/or moderate or greater mitral valve disease (mitral stenosis or regurgitation), or status post mitral valve replacement
- Use within 30 days of screening or current use of approved PH medications such as sildenafil or bosentan (use of Cialis® or Viagra® for erectile dysfunction is permitted)
- Use of investigational drugs or devices within 30 days prior to enrollment into the study
- Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory, 3-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects With World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated With Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects With WHO Group 3 PH Associated With Idiopathic Pulmonary Fibrosis (IPF) on LTOT (Part 2 and Part 3)
The objective of this exploratory study is to examine the utility of high resolution computed tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function of short term a) iNO administration and b) nitric oxide (NO) cylinder concentration using the investigational medical device INOpulse® DS-C in subjects with WHO Group 3 PH associated with COPD on LTOT (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic Pulmonary Fibrosis (IPF) on LTOT (Part 2 and Part 3)
Read the detailed description
This is an exploratory, two-part, clinical study to evaluate the utility of HRCT to measure the pharmacodynamic effects of short term, pulsed administration of iNO using the combination product, inhaled nitric oxide/INOpulse in subjects with PH associated with COPD on LTOT. The utility of HRCT to characterize the effect of iNO on pulmonary imaging parameters as a function of a) short term inhaled iNO administration and b) NO cylinder concentration will be studied. In this study, pulmonary hypertension (PH) is defined as a tricuspid regurgitation velocity (TRV) ≥ 2.9 meters/second (m/s) or sPAP ≥ 38 mmHg by 2-D echocardiogram with Doppler or a mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg by right heart catheterization.
Eleven subjects will be enrolled; the first 6 subjects enrolled will be assigned to Part 1, the next 2 subjects enrolled will be assigned to Part 2. After Part 1 has been completed and the results reviewed by the Sponsor, the next 4 subjects will be enrolled in Part 2. The Next three subjects will be participating in Part 3.
In Part 1, six (6) subjects with adequate kidney function will be randomized to receive the 30 mcg/kg IBW/hr doses of iNO using a cylinder concentration of 4880 ppm (6.0 mg/L).
The 2 subjects enrolled in Part 2a will be randomly assigned to 1 of 2 sequences (2 subjects/sequence) to receive iNO utilizing NO cylinder concentration (4880 ppm) at a dose of 75 mcg/kg IBW/hr or Placebo set at a dose of 75 mcg/kg IBW/hr . The 2 patients from Part 2a will enter Part 2b. During Part 2b patients will receive iNO utilizing NO cylinder concentration (4880 ppm) at a dose of 75 mcg/kg IBW/hr (INOpulse® setting of 75 mcg/kg IBW/hr) for 4 weeks for at least 12 hours/day.
The 3 subjects enrolled in Part 3a and 3b. Part 3a is dose titration visit, Part 3 is 4 weeks of treatment at dose identified in Paret 3a at the discretion of the Investigator. Part 3a: subjects will receive three different doses of iNO utilizing NO cylinder concentration of (4880ppm) at a dose of 5, 10 and 15 mcg/kg IBW/hr.
The 3 patients from Part 3a will enter Part 3b and will be administered open label iNO for 4 weeks/at least 12 hrs/day at the dose determined by the Investigator in Part 3a.
Subjects will be replaced if they are unable to complete all treatment visits or of evaluable HRCT data cannot be obtained.
- Conditions
- Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis
- Being tested
- inhaled Nitric Oxide - 30 mcg/kg IBW/hr, inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr, inhaled nitric oxide 75 mcg/kg IBW/hr
- Keywords
- Inhaled Nitric Oxide (iNO), Pulmonary Hypertension (PH), Chronic Obstructive Pulmonary Disease (COPD), Long Term Oxygen Therapy (LTOT), Idiopathic Pulmonary Fibrosis (IPF)
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled Nitric Oxide - 30 mcg/kg IBW/hrDrug
Also called inhaled NO, inhaled Nitric Oxide, iNO
inhaled Nitric Oxide in 30 mcg/kg IBW/hr doses Part 1
inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hrDrug
Also called inhaled NO, inhaled Nitric Oxide, iNO
inhaled inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr dose titration
inhaled nitric oxide 75 mcg/kg IBW/hrDrug
Also called iNO
inhaled nitric oxide 75 mcg/kg IBW/hr -Part 2b
| Study group | Role | What they receive |
|---|---|---|
| inhaled Nitric Oxide 30 mcg/kg IBW/hr | Active comparator | 30 mcg/kg IBW/hr of inhaled Nitric Oxide Part 1 Receives: Drug: inhaled Nitric Oxide - 30 mcg/kg IBW/hr |
| inhaled nitric oxide 75 mcg/kg IBW/hr | Active comparator | Part 2: 75mcg/Kg IBW/hr Receives: Drug: inhaled nitric oxide 75 mcg/kg IBW/hr |
| inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr | Active comparator | Part 3a: Dose tritration 5, 10 and 15 mcg/Kg IBW/hr Part 3b: continuing on dose determined by PI in 3a for 4 weeks Receives: Drug: inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr |
| Placebo | Placebo comparator | Placebo for 75 mcg/kg IBW/hr Receives: Drug: inhaled nitric oxide 75 mcg/kg IBW/hr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in lobar blood volume at total lung capacity (TLC) after dosing with pulsed iNO as measured by HRCT
Part 1: baseline to end of treatment (1 day)
Part 2: baseline to end of treatment (treatment visit B will occur at least 5 days and not more than 30 days after treatment visit A)
Measured: up to 4 weeks
Secondary outcomes (7)
Changes in baseline measured by HRCT after dosing with pulsed iNO in Blood vessel % and density on lobar level
Changes in baseline measured by HRCT after dosing with pulsed iNO in Blood vessel % and density on lobar level
Measured: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Total lung volume at TLC
Changes in baseline measured by HRCT after dosing with pulsed iNO in Total lung volume at TLC
Measured: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Lobar volumes at TLC
Changes in baseline measured by HRCT after dosing with pulsed iNO in Lobar volumes at TLC
Measured: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Internal airflow distribution based on lobar expansion
Changes in baseline measured by HRCT after dosing with pulsed iNO in Internal airflow distribution based on lobar expansion
Measured: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Airway volume down to generation 8-10 at TLC
Changes in baseline measured by HRCT after dosing with pulsed iNO in Airway volume down to generation 8-10 at TLC
Measured: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Computational Fluid Dynamics (CFD)-based resistance on lobar level
Changes in baseline measured by HRCT after dosing with pulsed iNO in Computational Fluid Dynamics (CFD)-based resistance on lobar level
Measured: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Ventilation/perfusion (V/Q) matching
Changes in baseline measured by HRCT after dosing with pulsed iNO in Ventilation/perfusion (V/Q) matching
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startMay 2015
- Primary completionJun 2017
- Study completion28 Jun 2017
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bellerophon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashika Ahmed, Study director, Bellerophon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267655
- Sponsor's protocol ID
- IK-7002-COPD-006
- Status last verified
- Aug 2017
- First submitted
- 7 Oct 2014
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, 3-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging Parameters in Subjects With World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated With Chronic Obstructive Pulmonary Disease (COPD) on Long-Term Oxygen Therapy (LTOT) (Part 1) and in Subjects With WHO Group 3 PH Associated With Idiopathic Pulmonary Fibrosis (IPF) on LTOT (Part 2 and Part 3)
- ClinicalTrials.gov ID
- NCT02267655
- Acronym / sponsor ID
- IK-7002-COPD-006
- Conditions
- Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis
- Keywords
- Inhaled Nitric Oxide (iNO), Pulmonary Hypertension (PH), Chronic Obstructive Pulmonary Disease (COPD), Long Term Oxygen Therapy (LTOT), Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BellerophonIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 17 Oct 2014 (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 objective of this exploratory study is to examine the utility of high resolution computed tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function of short term a) iNO administration and b) nitric oxide (NO) cylinder concentration using the investigational medical device INOpulse® DS-C in subjects with WHO Group 3 PH associated with COPD on LTOT (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic Pulmonary Fibrosis (IPF) on LTOT (Part 2 and Part 3)
Detailed description
This is an exploratory, two-part, clinical study to evaluate the utility of HRCT to measure the pharmacodynamic effects of short term, pulsed administration of iNO using the combination product, inhaled nitric oxide/INOpulse in subjects with PH associated with COPD on LTOT. The utility of HRCT to characterize the effect of iNO on pulmonary imaging parameters as a function of a) short term inhaled iNO administration and b) NO cylinder concentration will be studied. In this study, pulmonary hypertension (PH) is defined as a tricuspid regurgitation velocity (TRV) ≥ 2.9 meters/second (m/s) or sPAP ≥ 38 mmHg by 2-D echocardiogram with Doppler or a mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg by right heart catheterization.
Eleven subjects will be enrolled; the first 6 subjects enrolled will be assigned to Part 1, the next 2 subjects enrolled will be assigned to Part 2. After Part 1 has been completed and the results reviewed by the Sponsor, the next 4 subjects will be enrolled in Part 2. The Next three subjects will be participating in Part 3.
In Part 1, six (6) subjects with adequate kidney function will be randomized to receive the 30 mcg/kg IBW/hr doses of iNO using a cylinder concentration of 4880 ppm (6.0 mg/L).
The 2 subjects enrolled in Part 2a will be randomly assigned to 1 of 2 sequences (2 subjects/sequence) to receive iNO utilizing NO cylinder concentration (4880 ppm) at a dose of 75 mcg/kg IBW/hr or Placebo set at a dose of 75 mcg/kg IBW/hr . The 2 patients from Part 2a will enter Part 2b. During Part 2b patients will receive iNO utilizing NO cylinder concentration (4880 ppm) at a dose of 75 mcg/kg IBW/hr (INOpulse® setting of 75 mcg/kg IBW/hr) for 4 weeks for at least 12 hours/day.
The 3 subjects enrolled in Part 3a and 3b. Part 3a is dose titration visit, Part 3 is 4 weeks of treatment at dose identified in Paret 3a at the discretion of the Investigator. Part 3a: subjects will receive three different doses of iNO utilizing NO cylinder concentration of (4880ppm) at a dose of 5, 10 and 15 mcg/kg IBW/hr.
The 3 patients from Part 3a will enter Part 3b and will be administered open label iNO for 4 weeks/at least 12 hrs/day at the dose determined by the Investigator in Part 3a.
Subjects will be replaced if they are unable to complete all treatment visits or of evaluable HRCT data cannot be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| inhaled Nitric Oxide 30 mcg/kg IBW/hr | Active comparator | Drug: inhaled Nitric Oxide - 30 mcg/kg IBW/hr30 mcg/kg IBW/hr of inhaled Nitric Oxide Part 1 |
| inhaled nitric oxide 75 mcg/kg IBW/hr | Active comparator | Drug: inhaled nitric oxide 75 mcg/kg IBW/hrPart 2: 75mcg/Kg IBW/hr |
| inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr | Active comparator | Drug: inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hrPart 3a: Dose tritration 5, 10 and 15 mcg/Kg IBW/hr Part 3b: continuing on dose determined by PI in 3a for 4 weeks |
| Placebo | Placebo comparator | Drug: inhaled nitric oxide 75 mcg/kg IBW/hrPlacebo for 75 mcg/kg IBW/hr |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must meet all of the following inclusion criteria to be enrolled and eligible to participate in the study:
Key exclusion criteria (19 listed)
- Subjects who meet any of the following criteria are not eligible for enrollment:
- > moderate (i.e., > Grade 2), or
- estimated GFRMDRD = 175×Scr -1.154×Age-0.203 ×1.212 (if black) ×0.742 (if female)
- where Scr = Standardized serum creatinine
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 Oxide - 30 mcg/kg IBW/hrAlso: inhaled NO, inhaled Nitric Oxide, iNOinhaled Nitric Oxide in 30 mcg/kg IBW/hr doses Part 1 | Drug | inhaled Nitric Oxide 30 mcg/kg IBW/hr |
| inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hrAlso: inhaled NO, inhaled Nitric Oxide, iNOinhaled inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr dose titration | Drug | inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr |
| inhaled nitric oxide 75 mcg/kg IBW/hrAlso: iNOinhaled nitric oxide 75 mcg/kg IBW/hr -Part 2b | Drug | Placebo, inhaled nitric oxide 75 mcg/kg IBW/hr |
Primary outcome
Change from baseline in lobar blood volume at total lung capacity (TLC) after dosing with pulsed iNO as measured by HRCT
Time frame: up to 4 weeks
Part 1: baseline to end of treatment (1 day) Part 2: baseline to end of treatment (treatment visit B will occur at least 5 days and not more than 30 days after treatment visit A)
7 secondary outcomes
Changes in baseline measured by HRCT after dosing with pulsed iNO in Blood vessel % and density on lobar level
Time frame: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Total lung volume at TLC
Time frame: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Lobar volumes at TLC
Time frame: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Internal airflow distribution based on lobar expansion
Time frame: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Airway volume down to generation 8-10 at TLC
Time frame: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Computational Fluid Dynamics (CFD)-based resistance on lobar level
Time frame: up to 4 weeks
Changes in baseline measured by HRCT after dosing with pulsed iNO in Ventilation/perfusion (V/Q) matching
Time frame: up to 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 21 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Ashika Ahmed study director
Bellerophon Therapeutics
1 site 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 Nitric Oxide - 30 mcg/kg IBW/hr, inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr and inhaled nitric oxide 75 mcg/kg IBW/hr in people with Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by Bellerophon at 1 site in Belgium.
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 11 inclusion and 19 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in lobar blood volume at total lung capacity (TLC) after dosing with pulsed iNO as measured by HRCT (time frame: up to 4 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 21 Feb 2023.