--- title: A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis nct_id: NCT05747508 overall_status: UNKNOWN phase: PHASE2 sponsor: Bellerophon study_type: INTERVENTIONAL primary_condition: Pulmonary Fibrosis countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05747508.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05747508" ct_last_update_post_date: 2023-02-28 last_seen_at: "2026-05-12T06:47:50.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis **Official Title:** A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide (iNO) in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2) **NCT ID:** [NCT05747508](https://clinicaltrials.gov/study/NCT05747508) ## Key Facts - **Status:** UNKNOWN - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 85 - **Lead Sponsor:** Bellerophon - **Conditions:** Pulmonary Fibrosis, Pulmonary Hypertension - **Start Date:** 2017-12-29 - **Completion Date:** 2023-12 - **CT.gov Last Update:** 2023-02-28 ## Brief Summary A randomized, double-blind, placebo-controlled dose escalation study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis on long term oxygen therapy. ## Detailed Description A Phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide in subjects with and without pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 85 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Diagnosed with pulmonary fibrosis by high resolution CT scan performed in the 6 months prior to screening associated with one of the following conditions and confirmed using one of the following guidelines, as per American Thoracic Society (AGS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT): * Major idiopathic interstitial pneumonias (IIPs) diagnosis or suspected as one of the following: * Idiopathic pulmonary fibrosis * Idiopathic nonspecific interstitial pneumonia * Respiratory bronchiolitis-interstitial lung disease * Desquamative interstitial pneumonia * Cryptogenic organizing pneumonia * Acute interstitial pneumonia * Rare IIPs diagnosis by one of the following: * Idiopathic lymphoid interstitial pneumonia * Idiopathic pleuroparenchymal fibroelastosis * Unclassifiable idiopathic interstitial pneumonias * Chronic hypersensitivity pneumonitis * Occupational lung disease * Have been using oxygen therapy by nasal cannula for at least 4 weeks * 6-Minute Walk Distance (6MWD) ≥ 100 meters and ≤ 450 meters at screening and Baseline/Randomization visits * World Health Organization (WHO) Functional Class II-IV * Forced Vital Capacity ≥ 40% predicated within the last 6 months prior to the screening run-in period * Age between 18 and 85 years (inclusive) Exclusion Criteria: * Pregnant or breastfeeding females at Screening * In the last 6 months prior to screening, evidence of any connective tissue disease with FVC \> 60% unless there is evidence of moderate to severe fibrosis on CT scan in the opinion of the local radiologist/Investigator ``` ## Arms - **Inhaled Nitric Oxide (iNO)** (ACTIVE_COMPARATOR) — Pulsed inhaled iNO30, 45 and 75 mcg/kg Ideal Body Weight (IBW)/hour (hr) - **Placebo** (PLACEBO_COMPARATOR) — Pulsed inhaled N2, 99.999% gas - **Long Term Follow Up** (ACTIVE_COMPARATOR) — Pulsed inhaled iNO30, 45 or 75 mcg/kg IBW/hr ## Interventions - **INOpulse®** (COMBINATION_PRODUCT) — Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula - **Placebo** (COMBINATION_PRODUCT) — Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula - **Long Term Follow Up** (COMBINATION_PRODUCT) — Patients will be treated by means of an INOpulse® device using an INOpulse® nasal cannula ## Primary Outcomes - **Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity.** _(time frame: Change from baseline to week 8 or 16)_ — Part 1 - Blinded Treatment Period ## Locations (23) - Arizona Pulmonary Specialists, Phoenix, Arizona, United States - University of California, Los Angeles, California, United States - University of California Davis Health, Sacramento, California, United States - University of Colorado Hospital, Aurora, Colorado, United States - University of Miami, Miami, Florida, United States - Avanza Medical Research Center, Pensacola, Florida, United States - Emory University, Atlanta, Georgia, United States - Piedmont Healthcare Pulmonary & Critical Care Research, Austell, Georgia, United States - Loyola University, Chicago, Illinois, United States - Norton Pulmonary Specialists, Louisville, Kentucky, United States - University of Michigan, Ann Arbor, Michigan, United States - The Lung Research Center (St. Luke's), Chesterfield, Missouri, United States - The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States - University of Cincinnati College of Medicine, Cincinnati, Ohio, United States - Thomas Jefferson University Korman Respiratory Institute, Philadelphia, Pennsylvania, United States - Temple University Hospital, Philadelphia, Pennsylvania, United States - Medical University of South Carolina, Charleston, South Carolina, United States - Vanderbilt University Medical Center, Nashville, Tennessee, United States - University of Texas Southwestern Medical Center, Dallas, Texas, United States - University of Utah Health Sciences, Salt Lake City, Utah, United States - Inova Heart and Vascular Institute Advanced Lung Disease Clinic, Falls Church, Virginia, United States - Pulmonary Associates of Richmond, Richmond, Virginia, United States - University of Washington Medical Center, Seattle, Washington, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.arizona pulmonary specialists|phoenix|arizona|united states` — added _(2026-05-12)_ - `locations.university of california|los angeles|california|united states` — added _(2026-05-12)_ - `locations.university of california davis health|sacramento|california|united states` — added _(2026-05-12)_ - `locations.university of colorado hospital|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.university of miami|miami|florida|united states` — added _(2026-05-12)_ - `locations.avanza medical research center|pensacola|florida|united states` — added _(2026-05-12)_ - `locations.emory university|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.piedmont healthcare pulmonary & critical care research|austell|georgia|united states` — added _(2026-05-12)_ - `locations.loyola university|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.norton pulmonary specialists|louisville|kentucky|united states` — added _(2026-05-12)_ - `locations.university of michigan|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.the lung research center (st. luke's)|chesterfield|missouri|united states` — added _(2026-05-12)_ - `locations.the university of north carolina at chapel hill|chapel hill|north carolina|united states` — added _(2026-05-12)_ - `locations.university of cincinnati college of medicine|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.thomas jefferson university korman respiratory institute|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.temple university hospital|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.medical university of south carolina|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.vanderbilt university medical center|nashville|tennessee|united states` — added _(2026-05-12)_ - `locations.university of texas southwestern medical center|dallas|texas|united states` — added _(2026-05-12)_ - `locations.university of utah health sciences|salt lake city|utah|united states` — added _(2026-05-12)_ - `locations.inova heart and vascular institute advanced lung disease clinic|falls church|virginia|united states` — added _(2026-05-12)_ - `locations.pulmonary associates of richmond|richmond|virginia|united states` — added _(2026-05-12)_ - `locations.university of washington medical center|seattle|washington|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05747508.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05747508* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*