Clinical Trials

 CT scan showing emphysema in alpha-1 antitrypsin deficiency

Asthma

  • Airway Blood Flow - Asthma study for Exercise-Induced Asthma, Smokers-Non-smokers and Ex-smokers
  • SARA - (Study of Acid Reflux and Asthma) - This research study is to determine if adding treatment for gastroesophageal reflux to inhaled steroid therapy in asthmatics reduces the number of asthma flare-ups.  Gastroesophageal reflux means that more stomach acid than usual is getting up into the esophagus (swallowing tube).  This condition is usually called GE reflux or GERD. GE reflux may worsen asthma symptoms, but it is not clear how important this effect might be.

For more information call 305-243-2568

COPD

  • ECLIPSE -A three year longitudinal study to identify novel endpoints and compare these with forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD severity and its progression over time.  Control subjects (smoking and never smokers) will be recruited as comparators with the COPD subjects.

For more information call 305-243-2568

Alpha 1-Antithypsin Deficiency

  • STAMP ( Safety and Tolerability of Alpha-1 MP) - Multi-Center, Open Label Trial to Evaluate the Safety and Tolerability of Alpha-1 MP in Subjects with Alpha-1 Antitrypsin(ATT) Deficiency
  • CHAMP (Talecris) -  A Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparability of Alpha-1 MP to Prolastin® in Subjects with Alpha 1-Antitrypsin Deficiency.

For more information call 305-243-2568

Interstitial Fibrosis/IPF

Idiopathic Pulmonary Fibrosis (IPF), also described as cryptogenic fibrosing alveolitis, is one of a family of Interstitial Lung Diseases (ILD) also know as Idiopathic Interstitial Pneumonia (IIP).  These disorders share clinical characteristics of shortness of breath, diffuse pulmonary infiltrates evident radiographically, and different degrees of inflammation, fibrosis, or both on lung biopsy.  There are different types of IIP, but the term IPF should be referred to the patients who have Usual Interstitial Pneumonia (UIP) histopathology and lack any evidence of an associated connective tissue disorder.  IPF is characterized by patchy, irreversible fibrosis as result of chronic lung injury with scarring and honeycombing of the lungs, and presence of prominent fibroblast foci as a result of acute lung injury.  To date, there are no proven therapies for IPF. 

Based on new pathophysiological concepts of IPF, there are different investigational agents under preclinical and clinical trials and with the increasing number of on going trials there are hopes for an effective therapeutic agent discovery.  The multi-center clinical trials described below, either as completed or ongoing trials raise the hope for future new strategies which may help to improve the quality of life and prognosis of disease in this group of patients in the near future.

  • PIRFENIDONE (InterMune PIPF-004) - A randomized, double-blinded, placebo-controlled, three-arm, multicenter, phase III study of Pirfenidone in patients with IPF. Up to 325 patients globally are assigned randomly in a three arm study (2:2:1) to receive 2403 mg/d of Pirfenidone (n = 130 patients), placebo equivalent (n = 130 patients), or 1197 mg/d of pirfenidone (n = 65 patients) in divided doses TID.

    Purpose of the Research Study - The primary objective is to assess the safety of Pirfenidone compared to placebo in patients with IPF.  The secondary objective is to measure the efficacy of Pirfenidone by absolute change in percent predicted FVC from Baseline to Week 60.  Other outcome measures include the 6-minute walk test, shortness of breath, percentage predicted DLCO/TLC, and survival-adjusted quality of life.

  • SILDENAFIL(VA) - The study involves 30 subjects from VA Medical Center with IPF and Pulmonary Hypertension.  The duration of the study is 6 months.

    Purpose of the Research Study -The long term goal of the study is to improve both exercise ability and the feeling of shortness of breath in patients with IPF and Pulmonary Hypertension. 

  • GLEEVEC ((Novartis)- Phase II, randomized, double-blinded, placebo controlled study of the safety and clinical effects of Gleevec (Imatinib mesylate) administered orally to patients with Idiopathic Pulmonary Fibrosis (IPF).

Purpose of the Research Study - To gain information about the safety and effectiveness of Gleevec in comparison to a placebo (an active substance that contains no medication) in patients with idiopathic pulmonary fibrosis (IPF) who have not responded to standard therapy.  Secondary purposes are to evaluate the quality of life while involved in this study. The duration is approximately 96 weeks

  • ACTIMMUNE (InterMune GIPF007) -  A randomized, double-blinded, multinational, Phase III study of the safety and efficacy of 200 micrograms SC Interferon Gamma 1b in patients with Idiopathic Pulmonary Fibrosis (IPF). A total number of 826 study subjects are enrolled.

    Purpose of the Research Study - To evaluate the overall survival time from the time of randomization. Other outcome measures include changes from baseline in the followings: 6minute walk test, shortness of breath, percentage predicted FVC, percentage  predicted DLCO/TLC, total days of hospitalization, and survival-adjusted quality of life.
  • ILOPROST (Cotherix C200-300)-  A randomized, double-blinded, placebo-controlled, multinational, phase II study to evaluate the safety and efficacy of Iloprost inhalation solution in subjects with abnormal Pulmonary Arterial Pressure (PAP)  and exercise limitation associated with IPF.

    Purpose of the Research Study - The primary goal is to assess the safety of Iloprost inhalation solution in subjects with IPF and abnormal PAP.  The secondary objective is to evaluate the efficacy of inhaled Iloprost as measured by improvement in 6-minute walk test (6MWT) and Borg dyspnea and fatigue scale reduction in exercise-associated oxygen desaturation, and clinical status.

For more information on these trials call 305-243-3728

Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension (PAH)  is a condition where the blood pressure is too high in the blood vessels between the heart and the lungs.  Possible symptoms associated with PAH are tiredness, dizziness, and shortness of breath.  These symptoms usually get worse over time due to the decreased pumping ability of the heart.  If you have a diagnosis of PAH, you may be eligible to participate in a clinical trial.

  • COTHERIX - A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients with Pulmonary Arterial Hypertension Receiving Oral Sildenafil.

The Division of Pulmonary and Critical Care Medicine of University of Miami is seeking subjects who have PAH to participate in a research study. The subject has to be currently on a stable dose of oral sildenafil either with or without bosentan. This study is being done to see if the addition of inhaled iloprost solution to your current sildenafil treatment might help improve the symptoms connected to PAH. Sildenafil was approved by the U.S. Food and Drug Administration (FDA) for treatment of PAH. Iloprost (Ventavis®) also was approved by the U.S. Food and Drug Administration (FDA) in December 2004 for the treatment of PAH. Approximately 180 subjects will participate in this study.

To find out more about any aspect of this study call: (305) 243-2568.