A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Bellerophon

Status and phase: Unknown; Phase 2

Conditions: Pulmonary Fibrosis; Pulmonary Hypertension

Treatments: Combination Product: INOpulse®; Combination Product: Long Term Follow Up; Combination Product: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05747508

PULSE-PHPF-001 Phase 2

Details and patient eligibility

About

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.

Full 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)

Enrollment: 85 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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85 participants in 3 patient groups, including a placebo group

Inhaled Nitric Oxide (iNO)

Active Comparator group

Description:

Pulsed inhaled iNO30, 45 and 75 mcg/kg Ideal Body Weight (IBW)/hour (hr)

Treatment:

Combination Product: INOpulse®

Placebo

Placebo Comparator group

Description:

Pulsed inhaled N2, 99.999% gas

Treatment:

Combination Product: Placebo

Long Term Follow Up

Active Comparator group

Description:

Pulsed inhaled iNO30, 45 or 75 mcg/kg IBW/hr

Treatment:

Combination Product: Long Term Follow Up