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Mucolytic Agent
Efficacy/Safety of HA Inhalation Solution for Hereditary Emphysema in Patients With Alpha-1 Antitrypsin Deficiency
Phase 2
Waitlist Available
Led By Gerard M Turino, MD
Research Sponsored by Gerard Turino
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
All Individual Drugs Already Approved
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
Eligible Conditions
- Alpha-1 Antitrypsin Deficiency
- CPFE Syndrome
- Emphysema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of pulmonary function tests
Measurement of sputum, plasma and urine concentrations of desmosine and isodesmosine
Secondary study objectives
Assessment of St. George Respiratory Questionnaire
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hyaluronic Acid inhalation solutionExperimental Treatment1 Intervention
3mL of 0.03% Hyaluronic Acid inhalation solution BID for 28 days
Group II: Placebo Inhalation SolutionPlacebo Group1 Intervention
3mL matching placebo inhalation solution BID for 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyaluronic acid
FDA approved
Find a Location
Who is running the clinical trial?
Gerard TurinoLead Sponsor
Gerard M Turino, MDPrincipal InvestigatorMount Sinai St Lukes