Oral Fosamprenavir-Sodium Alginate for LPR

Phase 2

Not yet recruiting

• Conditions: Laryngopharyngeal Reflux
• Interventions: Drug: Fosamprenavir Calcium; Other: Placebo

• Registration Number: NCT04383262
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

Laryngopharyngeal reflux (LPR) causes chronic cough, throat clearing, hoarseness, and dysphagia and if left untreated can promote the development of laryngeal cancer. More than 20% of the United Stated population suffer from LPR, yet there is no effective medical therapy. Proton pump inhibitors (PPIs), which inhibit gastric acid production but do not prevent reflux events, continue to be prescribed for LPR despite their poor efficacy for this patient population, high cost ($26 billion/year), and associated risks. Pepsin, detected in the airway of these patients and now known to cause laryngeal inflammation and promote disease independent of gastric acid, is a key therapeutic target. We report preclinical studies of select HIV inhibitors that bind to and inhibit pepsin and thus hold promise for the treatment of LPR. In support, a very low incidence of LPR was found in patients taking these drugs compared to the general population. HIV inhibitors are ideal drugs to repurpose because they target a foreign virus. Thus, a repurposing approach can be used to safely perform proof of concept testing of the efficacy of a pepsin inhibitor for LPR. The Specific Aim of this project is to perform a 12-week randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of fosamprenavirvpills for LPR. Fosamprenavir will be used at the FDA approved, manufacturers recommended dose for HIV for 12 weeks in medically refractory patients with clinically diagnosed moderate/severe LPR and combined multi-channel intraluminal impedance - pH (MII-pH) confirmed laryngeal reflux events. Routine clinical outcome measures for LPR (Reflux Symptom Index, Reflux Finding Score, Voice Handicap Index) will be documented pre- and post-treatment with Oral Fosamprenavir for LPR(n = 52) and placebo (n = 52). Additional research measures will include repeat administration of a newly created Daily Symptom Reflex Diary, as well as an intermittently distributed Patient Global Impression - Static \& Change scales. There is currently no effective medical therapy for LPR and pepsin is the key therapeutic target. Identification of an FDA approved drug which inhibits pepsin allows for a clinical trial to determine efficacy using a faster and safer repurposing approach to address a significant gap.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Study Start: 2025-09-01
• Primary Completion: 2027-06-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Fosamprenavir pills	Fosamprenavir Calcium	FOS: 1,400 mg fosamprenavir calcium b.i.d. (AM/PM) for 12 weeks
Placebo	Placebo	Sodium Alginate: for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Daily Symptom Reflux Diary (DRSD)	From baseline to 12-week post-treatment.	Difference in response as indicated by change in DRSD score between FOS and placebo arms comprised of patients meeting inclusion criteria, and grouped according to randomized treatment assignment.
Change in Reflux Symptom Index (RSI)	Baseline to 12-week post-treatment.	Difference in response as indicated by change in RSI score, between FOS and placebo arms comprised of patients meeting inclusion criteria and grouped according to randomized treatment assignment.

Trial Locations

Locations (1)

Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States