Pacific Pulmonary Medical Group actively pursues promising research, offering patients the opportunity to be among the first to benefit from advances in medicine. Everyday research uncovers new information about diseases and their treatment. By taking part in a research study, you can help to prove the efficacy and new indications of both new and current medications.
The INCREASE Study
A Randomized , Double Blind, Placebo-Controlled Phase II/III study to evaluate the safety and efficacy of inhaled Treprostinil in subjects with Pulmonary Hypertension due to Parenchymal Lung Disease including:- Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, or Combined Pulmonary Fibrosis and Emphysema.
RESEARCH STUDY SUMMARY
A clinical research study of Inhaled Treprostinil and Placebo for the treatment of Pulmonary Hypertension, Interstitial Lung Disease or Combined Pulmonary Fibrosis and Emphysema
RESEARCH STUDY TITLE
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease
This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 100 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).
KEY ELIGIBILITY CRITERIA
- Males and Females aged 18-79
- Confirmed diagnosis of WHO Group 3 PH
- Has not received any PAH approved therapy within 60 days of randomization
- Right Heart Catherization (RHC) within one year prior to randomization
- Baseline 6MWD ≥ 100 meters
- Baseling diffusing capacity of the lungs for carbon monoxide (DLCO) < 50%
If you are interested in participating in a clinical trial or have questions, please contact our Clinical Research Coordinator at 951-373-5827