Efficacy/Safety of HA Inhalation Solution for Hereditary Emphysema in Patients With Alpha-1 Antitrypsin Deficiency
NCT03114020 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2020-04-21
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
Conditions
- Emphysema
- Alpha 1-Antitrypsin Deficiency
Interventions
- 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
Sponsors & Collaborators
-
Gerard Turino
lead INDIV
Principal Investigators
-
Gerard M Turino, MD · Mount Sinai St Lukes
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-22
- Primary Completion
- 2019-11-12
- Completion
- 2019-11-12
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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