Current Research at Paloma Medical Group
Current Enrolling Clinical Trials
ADAPT (Still active and enrolling)
This prospective, observational, multicenter, patient registry will follow patients who are receiving treatment with Orenitram for the treatment of PAH for up to 78 weeks from Orenitram initiation. The primary objective is to observe and assess the real-world use and tolerability of Orenitram. Approximately 300 patients, enrolled at approximately 70 study sites in the US. The patient must be at least 18 years old of age or older.
GSK COPD (Enrollment is closed)
This registry addresses whether the incidence rates of cardiovascular and cerebrovascular events differ for new users of umeclidinium bromide/vilanterol trifenatate (UMEC/VI) combination or umeclidinium bromide (UMEC) compared with tiotropium in patients diagnosed with Chronic Obstructive Pulmonary Disease. This will be determined by evaluating the incidence rates and frequency of hospitalizations, CV adverse events, stroke, as well as evaluating medication compliance. This registry is actively recruiting COPD patients newly started on umeclidinium bromide/vilanterol trifenatate (UMEC/VI) combination, umeclidinium bromide (UMEC), or tiotropium. The patient must be at least 18 years old of age or older.
OPUS (Enrollment is closed)
This is a multicenter, long-term, prospective, longitudinal, real-world, drug registry of Opsumit new users, and is a stand-alone observational study. Patients will be followed by their physician according to routine clinical practice. The study protocol will not mandate any specific schedule of visits or investigations. All consecutive patients newly treated with Opsumit in the participating centers will be invited to enroll in the registry. The planned observational period for each patient enrolled into the registry will be at least 1 year from study enrollment or until death, withdrawal of consent, loss to follow-up, or Opsumit discontinuation with an elapsed time of 30 days after the last dosing day of Opsumit. The study will end after the last patient enrolled is observed for 1 year. The patient must be at least 18 years old of age or older.
AIRWISE (Enrollment is closed)
This is a pragmatic randomized open label active controlled parallel group design trial conducted in real-world, community-based practice setting for a fixed duration of 12 months of treatment. All participating patients will already be on a LAMA, LABA or ICS/LABA for COPD, but will have been determined by their physician to not be controlled on their current therapy. Patients enrolled in the study will be randomized to either Stiolto Respimat or ICS plus LABA plus LAMA (triple therapy) and provided with a prescription for the assigned treatment. Priority will be given to patients actively enrolled in an Anthem affiliated health plan. The patient must be at least 18 years old of age or older.
Starscape - Roche (Enrollment will begin Soon)
This is a Phase III, randomized, double-blind, placebo controlled study that will treat patients with Interstitial Pulmonary Fibrosis via IV infusion with study drug PRM-151. Paloma Medical Group is 1 of only 3 sites on the west coast (only 26 in the entire US) that is participating in this groundbreaking international study. This is a very demanding study with requirements for long and frequent patient visits. The advantage of this study is that patients will not be required to stop their antifibrotic treatment while participating. Patients who successfully complete this 52 week study will be invited to participate in the Open Label Extension study where all participants will be given the PRM-151 study drug whether they were in the placebo group or not.
Bellepheron (Enrollment will begin Soon)
This is a Phase IIb/III, randomized, double-blind, placebo controlled dose escalation study to assess safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk of pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy. This device will replace but serve the same purpose as 24-hour oxygen therapy. Patients will come into the office every 4 months for a 1 hour long appointment to check on their progress. Patients who successfully complete this study will be invited to participate in the Open Label Extension study where all participants will be given the iNO study drug whether they were in the placebo group or not.
Pulmonary Support Groups
Pulmonary Arterial Hypertension
San Juan Capistrano Pulmonary Hypertension Support Group
*Affiliated with Pulmonary Hypertension Association (PHA)
Interstitial Lung Disease
San Juan Capistrano Pulmonary Fibrosis Support Group
*Affiliated with Pulmonary Fibrosis Foundation (PFF)
Details
When: Quarterly, Saturday’s 11 AM – 1 PM
Where: Intecore Physical Therapy Office (downstairs from Paloma Medical Group)
Address: 30230 Rancho Viejo Road, Suite 120, San Juan Capistrano, CA 92675
Contact: Bill Le (949) 404-3589 This email address is being protected from spambots. You need JavaScript enabled to view it.
