The purpose of the study is to evaluate the safety and efficacy of administering repeated doses of Hyaluronic Acid Inhalation Solution to subjects with Emphysema that have Alpha-1-Antitrypsin deficiency
The study primarily aims to establish desmosine and isodesmosine concentrations in plasma, sputum and urine measured as markers of elastin degradation systemically in the lung and also markers of inflammation and fibrinogen. Assessment of vital signs, lab tests, carbon monoxide diffusing capacity, oxygen saturation, pulmonary function tests, ECGs, physical exams and adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
twice a day 3 mL of 0.03% Hyaluronic Acid Inhalation Solution
Twice a day 3 ml of placebo inhalation solution
University of Miami Hospital
Miami, Florida, United States
Pulmonary Health Physicians, PC
Fayetteville, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Health Science Center
Tyler, Texas, United States
Measurement of sputum, plasma and urine concentrations of desmosine and isodesmosine
measurement of biomarkers
Time frame: 28 days
Assessment of pulmonary function tests
measurement of pulmonary function
Time frame: 28 days
Assessment of St. George Respiratory Questionnaire
measurement of patient abilities
Time frame: 28 days
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Medical College of Wisconsin / Froedtert Hospital
Milwaukee, Wisconsin, United States
Inspiration Research Limited
Toronto, Ontario, Canada