Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bellerophon
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)
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
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)
You may not be if
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
