Fosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction

Conditions

• Laryngopharyngeal Reflux

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• Fosamprenavir Calcium — DRUG
  A repurposing approach, prospective, placebo-controlled clinical trial of FOS-SA (used at 1,400 mg fosamprenavir calcium, twice daily) for 12 weeks in medically refractory patients with clinically diagnosed moderate/severe LPR (RSI \> 13, RFS \> 7 and MII-pH confirmed laryngeal reflux event\[s\]).
• Placebo — OTHER
  Non-active placebo pill formulation

Study Details

Laryngopharyngeal Reflux (LPR) is a common condition that causes symptoms like chronic cough, throat clearing, hoarseness, and trouble swallowing. If not treated, LPR can lead to long-term throat damage and may increase the risk of throat cancer. More than 20% of the people in the United States are estimated to have LPR, yet there is no effective medication approved to treat it. Drugs called proton pump inhibitors (PPIs) are often used to treat LPR, even though they were designed for stomach acid problems. These medications reduce acid but do not stop reflux from happening, so they often do not help LPR patients. Despite poor results, PPIs are widely prescribed, are very costly, and can cause side effects. Research shows that a digestive enzyme called pepsin plays a key role in LPR. Pepsin can damage the throat and voice box even when acid is not present. Laboratory studies found that certain HIV medications can block damage caused by pepsin. People taking these medications for HIV appear to have a much lower rate of LPR. This study will test fosamprenavir, an FDA-approved HIV drug, as a treatment for LPR. We will conduct a 14-week, double-blind, placebo-controlled clinical trial in patients with LPR who did not improve with standard treatment. Participants will receive either fosamprenavir or placebo, randomly, and symptoms will be measured before and after treatment using standard questionnaires and daily symptom tracking. Because there is no effective medical treatment for LPR. this study aims to test a safe, existing drug that targets the underlying cause of the disease.

Key Dates

First listed

May 12, 2020

Start date

Jul 15, 2026

Status verified

Apr 2026

Primary completion

Jul 1, 2027

Completion

Oct 1, 2028

Study Design

Enrollment

104 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Oral Fosamprenavir pills
  FOS: 1,400 mg fosamprenavir calcium b.i.d. (AM/PM) for 12 weeks
• Placebo Comparator: Placebo
  Sodium Alginate: for 12 weeks.

Primary Outcome Measure

Change in Reflux Symptom Index (RSI) [ Time Frame: Baseline to 12-week post-treatment. ]

Central Contacts

• Ally Vandenberg, BSc
  (414)955-2659
  [email protected]
• Nikki Johnston, PhD
  (414) 955-4075
  [email protected]

Locations (1)

Find similar trials in Milwaukee, WI

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