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Assessing Treatments for Patients with WHO Group 1 Pulmonary Arterial Hypertension


Title

Hypertension - Assessing Treatments for Patients with WHO Group 1 Pulmonary Arterial Hypertension

Therapeutic Area
Principal Investigator loana Preston, MD
Min Age 18 Years
Max Age 75 Years
Gender Both
Contact Karen Visnaw, RN
617-636-1334
More Information http://www.clinicaltrials.gov/

Overview

This protocol describes a Phase 2, multi-center, open-label, randomized (1: 1: 1 ),parallel-dose study to determine the safety and efficacy of inhaled nebulized AIR001 in subjects with WHO Group 1 PAH. Up to 90 subjects will be randomized and treated in approximately 40 centers in approximately 10 countries, providing 27 subjects have been treated in each of the 3 treatment groups. Recruitment will continue until this criterion is achieved. There will be a separate sub-study at selected sites to evaluate peak and trough hemodynamic catheterization parameters and pharmacokinetics. 
  
AIR001 will be delivered by the I-Neb AAD system

Study Details

Inclusion Criteria


Idiopathic (IPAH) or heritable pulmonary arterial hypertension (HPAH); or 
  
PAH associated with one of the following CTD: 
  1. Systemic sclerosis (scleroderma); 
  2. Limited scleroderma; 
  3. Mixed connective tissue disease; 
  4. Systemic lupus erythematosus; 
  5. Overlap syndrome. 

or PAH associated with: 
  1. Human immunodeficiency virus (HIV) infection; 
  2. Simple, congenital systemic-to-pulmonary shunts at least one year post surgical repair. 
  3. Exposure to legal drugs, chemicals and toxins, such as fenfluramine derivatives, other anorexigens, toxic rapeseed oil or L-tryptophan. Subjects with PAH associated with illegal drug use, such as methamphetamine, are excluded. 

Newly diagnosed PAH on no disease-specific PAH therapy or previously diagnosed with PAH on stable (i.e. 3 months (90 days) prior to the Baseline qualification cardiac catheterization) oral disease specific PAH therapy with either an ETRA and/or PDE-5i at stable doses. 
  
Has a 6MWT distance; 50 meters at Screening.

Exclusion Criteria

  • Participation in a device or other interventional clinical studies, with the exception of studies utilizing AIR001, within 1 month (30 days) of Baseline/Day 1 and/or during study participation. 
  • Receiving chronic treatment with prostacyclin/prostacyclin analogue within 2 months (60 days) of Baseline/Day 1.  Use of prostacyclin for acute vasodilator testing during cardiac catheterization is allowed. 
  • History of malignancy within 5-years prior to Baseline/Day 1, with the exception of localized nonmetastatic basal cell carcinoma of the skin and in-situ carcinoma of the cervix.

Study Requirements


Your participation will last about 22 weeks, not including the screening visit. 
  
Testing (at most visits) to include: 
  • Your medical history and current illnesses will be reviewed 
  • You will be asked about your PAH symptoms 
  • Your medications will be reviewed 
  • Information on your race, sex, etc. will be collected 
  • A physical exam will be performed 
  • Vitals signs will be collected (height, weight, respiratory rate, sitting blood pressure and heart rate, temperature, and pulse oximetry (which measures the amount of oxygen in your blood.) Your blood pressure, heart rate, pulse oximetry measured while you are lying flat on your back, sitting, and standing. 
  • Measurement of your exercise capacity (6 Minute Walk Test) 
  • Evaluation of your shortness of breath (Borg Scale) 
  • A 12-lead ECG (a record of your heartbeat) will be performed 
  • A 10ml (about 2 teaspoons) blood sample will be drawn for routine clinical laboratory tests (Chemistry and Hematology) 
  • A 5ml (about 1 teaspoon) blood sample will be drawn for a serum pregnancy test if you are a woman of childbearing potential 
  • Pulmonary Function testing (PFTs -breathing test to see how well your lungs work) if you have not had them done in the last 6 months 
  • Right heart catheterization (a catheter will be inserted into a large vein in your leg or neck until it reaches the pulmonary blood vessels on the right side of your heart. Once inside your heart, they will use the catheter to measure the pressure of the blood flowing through your heart and into your lungs) if you have not had it done in the last 30 days.
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