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Pulmonary HypertensionPhase 2NCT01728220

Two-Part Dose-Confirming Study of Pulsed Inhaled Nitric Oxide in Subjects With WHO Group 3 Pulmonary Hypertension Associated With COPD

A Phase 2 study testing Inhaled NO delivered via INOpulse DS-C Device in people with Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by Bellerophon Pulse Technologies at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a placebo-controlled, double-blind, parallel, randomized, two-part, dose-confirming clinical study characterizing the pharmacodynamic effects of pulsed iNO using the combination product, inhaled nitric oxide/INOpulse DS-C vs. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Inhaled NO delivered via INOpulse DS-C Device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
159 participants
Where
43 sitesUnited States
Study dates
Dec 2012to Jul 2014
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Former smokers with at least 10 pack-years of tobacco cigarette smoking history before study entry and who have stopped smoking ≥ 1 month prior to enrollment
  • Age ≥ 40 years, ≤ 80 years
  • A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria
  • A post-bronchodilatory forced expiratory volume in 1 second/forced vital capacity (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
  • Echocardiogram with technical adequacy demonstrating tricuspid regurgitation velocity (TRV) ≥ 2.9 m/s at Screening, as determined by a blinded central echocardiography laboratory
  • 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:
  • Positive urine cotinine test
  • Currently using, or having used within the past month, a nicotine patch
  • 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 an exacerbation requiring start of or increase in systemic oral corticosteroid therapy and/or hospitalization during the last month (ATS COPD Guidelines 2004)
Show all 14Show fewer
  • 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 mm Hg as measured during cardiac catheterization within the past 6 months unless documented to have resolved by a subsequent cardiac catheterization
  • 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

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • River Birch Research Alliance LLC

    Blue Ridge, Georgia, 30513

  • Graves-Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Medical Associates of North Georgia

    Canton, Georgia, 30114

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina, 29406

  • American Health Research

    Charlotte, North Carolina, 28207

  • Bay Area Chest Physicians

    Clearwater, Florida, 33756

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Neem Research Group Inc

    Columbia, South Carolina, 29201

  • Western Connecticut Medical Group PC

    Danbury, Connecticut, 06810

  • Clinical Trial Connection

    Flagstaff, Arizona, 86001

  • Gary J. Richmond, MD, PA

    Fort Lauderdale, Florida, 33316

  • Gaffney Pharmaceutical Research

    Gaffney, South Carolina, 29340

  • Greenville Pharmaceutical Research

    Greenville, South Carolina, 29615

  • East Coast Institute for Research

    Jacksonville, Florida, 32204

  • Jasper Summit Research LLC

    Jasper, Alabama, 35501

  • Pulmonary Disease Specialists PA

    Kissimmee, Florida, 34741

  • Kentucky Research Group

    Louisville, Kentucky, 40218

  • MedPharmics LLC

    Metairie, Louisiana, 70006

  • San Marcus Research Clinic Inc.

    Miami, Florida, 33015

  • St. Paul Medical Research Center Inc.

    Miami, Florida, 33126

  • IMIC, Inc.

    Miami, Florida, 33140

  • Elite Clinical Research

    Miami, Florida, 33144

  • South Florida Research Phase I-IV

    Miami, Florida, 33165

  • Health & Life Research Solutions Inc.

    Miami, Florida, 33173

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34653

  • Radin Cardiovascular Medical Associates

    Newport Beach, California, 92663

  • Central Florida Pulmonary Group, P.A.

    Orlando, Florida, 32803

  • Temple Lung Center Pulmonary & Critical Care Medicine

    Philadelphia, Pennsylvania, 19140

  • Pulmonary Associates P.A.

    Phoenix, Arizona, 85006

  • Physician HealthCare Network, PC

    Port Huron, Michigan, 48060

  • Zain Research LLC

    Richland, Washington, 99352

  • Pulmonary Associates of Richmond Inc

    Richmond, Virginia, 23225

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • Bassette Medical Research Inc.

    Sebring, Florida, 33872

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Research Alliance

    St. Petersburg, Florida, 33710

  • Pioneer Research Solutions, Inc.

    Sugar Land, Texas, 77479

  • Concept Clinical Trials, LLC

    Tamarac, Florida, 33319

  • Montefiore Medical Center-Weiler Division

    The Bronx, New York, 10461

  • Veritas Clinical Specialties, Ltd

    Topeka, Kansas, 66606

  • Waterbury Pulmonary Associates

    Waterbury, Connecticut, 06708

  • Axcess Medical Research

    Wellington, Florida, 33414

  • Florida Premier Research Institute

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Placebo-Controlled, Double-Blind, Parallel, Randomized, Two-Part, Clinical Dose-Confirming Study Of Pulsed, Inhaled Nitric Oxide (iNO) 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) INHALE 1

This is a placebo-controlled, double-blind, parallel, randomized, two-part, dose-confirming clinical study characterizing the pharmacodynamic effects of pulsed iNO using the combination product, inhaled nitric oxide/INOpulse DS-C vs. placebo 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).

Read the detailed description

This two-part study is designed to confirm the dose of inhaled nitric oxide (NO), administered through an investigational pulsed delivery device (INOpulse® DS-C) that results in decreased pulmonary arterial systolic pressure (PASP) without significantly affecting systemic oxygenation.

In Part A, 80 subjects will be randomized to 1of 4 treatment groups in a 1:1:1:1 ratio (with 20 subjects in each treatment group). Subjects assigned to an iNO group will receive pulsed iNO at a dose of 0.003 mg/kg IBW/hr, 0.010 mg/kg IBW/hr, or 0.015 mg/kg IBW/hr, with a set pulse width (PW) of 260 milliseconds (ms). Part A subjects assigned to the placebo group will receive nitrogen (N2) at a randomly assigned device setting of 0.003, 0.010 or 0.015 mg/kg IBW/hr with a set PW of 260 ms.

Subjects who were randomized in Part A are permitted to participate in Part B of the study. Subjects will need to be re-screened and re-randomized for Part B participation.

In Part B, 60 subjects will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (with 20 subjects in each treatment group). Subjects assigned to an iNO group will receive pulsed iNO at either 0.030 mg/kg IBW/hr or 0.075 mg/kg IBW/hr, with a set PW of 260 ms. Part B subjects assigned to placebo will receive N2 at a randomly assigned device setting of 0.030 mg/kg IBW/hr or 0.075 mg/kg IBW/hr with a set PW of 260 ms.

Part B will use a skewed block randomization scheme with 10 blocks of 6 subjects as follows:

  • Blocks 1-3: 3 subjects at 0.030 mg/kg IBW/hr, 1 subject at 0.075 mg/kg IBW/hr, and 2 subjects randomly assigned to placebo either 0.030 or 0.075 mg/kg IBW/hr
  • Blocks 4-7: 2 subjects at 0.030 mg/kg IBW/hr, 2 subjects at 0.075 mg/kg IBW/hr, and 2 subjects randomly assigned to placebo either 0.030 or 0.075 mg/kg IBW/hr
  • Blocks 8-10: 1 subject at 0.030 mg/kg IBW/hr, 3 subjects at 0.075 mg/kg IBW/hr, and 2 subjects randomly assigned to placebo either 0.030 or 0.075 mg/kg IBW/hr
Being tested
Inhaled NO delivered via INOpulse DS-C Device, Placebo delivered via INOpulse DS-C Device
Keywords
Inhaled nitric oxide (iNO), Pulmonary hypertension (PH), Chronic obstructive pulmonary disease (COPD), Long term oxygen therapy (LTOT)
Medical subject headings
Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled NO delivered via INOpulse DS-C DeviceCombination product

    Subjects will be treated with nitric oxide by means of an INOpulse DS-C device using an INOpulse nasal cannula.

  • Placebo delivered via INOpulse DS-C DeviceCombination product

    Subjects will be treated with nitrogen gas by means of an INOpulse DS-C device using an INOpulse nasal cannula.

Study groups in NCT01728220
Study groupRoleWhat they receive
Inhaled NO @ 0.003 mg/kg/ ideal body weight (IBW)/hr (Part A)Active comparatorInhaled NO using 3.0 mg/L [2440 ppm] NO minicylinder delivered via INOpulse® DS-C device
Receives: Combination Product: Inhaled NO delivered via INOpulse DS-C Device
Inhaled NO @ 0.010 mg/kg/IBW/hr (Part A)Active comparatorInhaled NO using 3.0 mg/L [2440 ppm] NO minicylinder delivered via INOpulse® DS-C device
Receives: Combination Product: Inhaled NO delivered via INOpulse DS-C Device
Inhaled NO @ 0.015 mg/kg/IBW/hr (Part A)Active comparatorInhaled NO using 6.0 mg/L [4880 ppm] NO minicylinder delivered via INOpulse® DS-C device
Receives: Combination Product: Inhaled NO delivered via INOpulse DS-C Device
Placebo random @ 0.003, 0.010 or 0.015 mg/kg/IBW/hr (Part A)Placebo comparatorPlacebo using 99.999% N2 minicylinder delivered via INOpulse® DS-C device
Receives: Combination Product: Placebo delivered via INOpulse DS-C Device
Inhaled NO @ 0.030 mg/kg IBW/hr (Part B)Active comparatorInhaled NO using 6.0 mg/L [4880 ppm] NO minicylinder delivered via INOpulse® DS-C device
Receives: Combination Product: Inhaled NO delivered via INOpulse DS-C Device
Inhaled NO @ 0.075 mg/kg IBW/hr (Part B)Active comparatorInhaled NO using 6.0 mg/L [4880 ppm] NO minicylinder delivered via INOpulse® DS-C device
Receives: Combination Product: Inhaled NO delivered via INOpulse DS-C Device
Placebo random @ 0.030 or 0.075 mg/kg/IBW (Part B)Active comparatorPlacebo using 99.999% N2 minicylinder delivered via INOpulse® DS-C device
Receives: Combination Product: Placebo delivered via INOpulse DS-C Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pulmonary arterial systolic pressure (PASP) from Baseline after treatment with iNO (measured by 2D transthoracic echocardiography with Doppler)

    Measured: baseline to end of treatment (1 day)

Secondary outcomes (1)

  1. The secondary outcome is the occurrence of a decrease ≥ 5 mm Hg of partial pressure of oxygen in arterial blood (PaO2) from Baseline after treatment with iNO

    Measured: baseline to end of treatment (1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionJun 2014
  4. Study completionJul 2014

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01728220
Sponsor's protocol ID
IK-7002-COPD-201
Status last verified
Jul 2022
First submitted
13 Nov 2012
Last updated
27 Feb 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inhaled NO delivered via INOpulse DS-C Device in people with Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by Bellerophon Pulse Technologies at 43 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 8 inclusion and 14 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 27 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 43 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. 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 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 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 in pulmonary arterial systolic pressure (PASP) from Baseline after treatment with iNO (measured by 2D transthoracic echocardiography with Doppler) (time frame: baseline to end of treatment (1 day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01728220.

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 27 Feb 2023.

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