Clinical Trial: Efficacy/Safety of HA Inhalation Solution for Hereditary Emphysema in Patients With A1Antitrypsin Deficiency
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase 2 Randomized Parallel-Group Double-Blind Placebo-Controlled Multiple-Dose Proof-of-Concept Study to Evaluate the Efficacy/Safety of Hyaluronic Acid Inhalation Solution for Treatment of
Brief Summary: 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
Detailed Summary: 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.
Sponsor: Gerard Turino
Current Primary Outcome:
- Measurement of sputum, plasma and urine concentrations of desmosine and isodesmosine [ Time Frame: 28 days ]measurement of biomarkers
- Assessment of pulmonary function tests [ Time Frame: 28 days ]measurement of pulmonary function
Original Primary Outcome: Same as current
Current Secondary Outcome: Assessment of St. George Respiratory Questionnaire [ Time Frame: 28 days ]
Original Secondary Outcome: Same as current
Information By: Turino, Gerard, M.D.
Dates:
Date Received: April 5, 2017
Date Started: March 22, 2017
Date Completion: December 2017
Last Updated: April 10, 2017
Last Verified: April 2017