NCT03114020

Efficacy/Safety of HA Inhalation Solution for Hereditary Emphysema in Patients With Alpha-1 Antitrypsin Deficiency

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 Emphysema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Gerard Turino · Individual
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Emphysema
• Alpha 1-Antitrypsin Deficiency

Interventions

Type	Name	Description
DRUG	Hyaluronic Acid Inhalation Solution	twice a day 3 mL of 0.03% Hyaluronic Acid Inhalation Solution
DRUG	Placebo Inhalation Solution	Twice a day 3 ml of placebo inhalation solution

Timeline

• Start date: 2017-03-22
• Primary completion: 2019-11-12
• Completion: 2019-11-12
• First posted: 2017-04-14
• Last updated: 2020-04-21

Locations

6 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study