Two-Part Dose-Confirming Study of Pulsed Inhaled Nitric Oxide in Subjects With WHO Group 3 Pulmonary Hypertension Associated With COPD
Public ClinicalTrials.gov record NCT01728220. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01728220
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 159 participants
Conditions and interventions
Interventions
- Inhaled NO delivered via INOpulse DS-C Device Combination Product
- Placebo delivered via INOpulse DS-C Device Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2012 (Type not available)
- Primary completion
- Jun 2014 (Actual)
- Completion
- Jul 2014 (Actual)
- Last update posted
- Feb 27, 2023
2012 – 2014
United States locations
- U.S. sites
- 43
- U.S. states
- 18
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Jasper Summit Research LLC | Jasper | Alabama | 35501 | — |
| Clinical Trial Connection | Flagstaff | Arizona | 86001 | — |
| Pulmonary Associates P.A. | Phoenix | Arizona | 85006 | — |
| Radin Cardiovascular Medical Associates | Newport Beach | California | 92663 | — |
| Western Connecticut Medical Group PC | Danbury | Connecticut | 06810 | — |
| Waterbury Pulmonary Associates | Waterbury | Connecticut | 06708 | — |
| Bay Area Chest Physicians | Clearwater | Florida | 33756 | — |
| Gary J. Richmond, MD, PA | Fort Lauderdale | Florida | 33316 | — |
| East Coast Institute for Research | Jacksonville | Florida | 32204 | — |
| Pulmonary Disease Specialists PA | Kissimmee | Florida | 34741 | — |
| 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 | — |
| Central Florida Pulmonary Group, P.A. | Orlando | Florida | 32803 | — |
| Bassette Medical Research Inc. | Sebring | Florida | 33872 | — |
| Research Alliance | St. Petersburg | Florida | 33710 | — |
| Concept Clinical Trials, LLC | Tamarac | Florida | 33319 | — |
| Axcess Medical Research | Wellington | Florida | 33414 | — |
| Florida Premier Research Institute | Winter Park | Florida | 32789 | — |
| River Birch Research Alliance LLC | Blue Ridge | Georgia | 30513 | — |
| Medical Associates of North Georgia | Canton | Georgia | 30114 | — |
| Veritas Clinical Specialties, Ltd | Topeka | Kansas | 66606 | — |
| Graves-Gilbert Clinic | Bowling Green | Kentucky | 42101 | — |
| Kentucky Research Group | Louisville | Kentucky | 40218 | — |
| MedPharmics LLC | Metairie | Louisiana | 70006 | — |
| Physician HealthCare Network, PC | Port Huron | Michigan | 48060 | — |
| Montefiore Medical Center-Weiler Division | The Bronx | New York | 10461 | — |
| American Health Research | Charlotte | North Carolina | 28207 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Temple Lung Center Pulmonary & Critical Care Medicine | Philadelphia | Pennsylvania | 19140 | — |
| Lowcountry Lung and Critical Care | Charleston | South Carolina | 29406 | — |
| Neem Research Group Inc | Columbia | South Carolina | 29201 | — |
| Gaffney Pharmaceutical Research | Gaffney | South Carolina | 29340 | — |
| Greenville Pharmaceutical Research | Greenville | South Carolina | 29615 | — |
| Clinical Research of Rock Hill | Rock Hill | South Carolina | 29732 | — |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | — |
| Pioneer Research Solutions, Inc. | Sugar Land | Texas | 77479 | — |
| Pulmonary Associates of Richmond Inc | Richmond | Virginia | 23225 | — |
| Zain Research LLC | Richland | Washington | 99352 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01728220, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 27, 2023 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01728220 live on ClinicalTrials.gov.