Fosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction

ConditionLaryngopharyngeal Reflux

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-64

SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hepatic Function Panel must be within normal limits

Results from V1 safety labs must all be within normal limits

Patient agrees not to make any changes to their usual diet and/or anti-reflux medications during the study.

Patient is compliant with eDiary completion; that is, they have completed the eDiary questions on at least 5 days each week during the 14 calendar days before the start of the Treatment Period.

Disqualifiers

Age ≥ 65 years 2. Patient is not fluent and literate in English. 3. Pregnant (or plan to be) and nursing mothers 4. Women of child-bearing potential not willing to comply with contraceptive requirements during the study treatment and for 1 week following the last dose of study drug.

Contraceptive requirements Fosamprenavir may decrease the effectiveness of combined hormonal contraception through significant CYP3A4 induction of estrogen. If subjects' preferred choice of contraception is combined hormonal contraception, subjects must also agree to use a second method of contraception (condom + spermicide) during study drug treatment.

Medroxyprogesterone acetate injectable

Intrauterine Device

Trial design

Design model

Parallel

Treatments tested in this trial

Fosamprenavir Calcium
Drug
A repurposing approach, prospective, placebo-controlled clinical trial of Fosamprenavir (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 intervention
Non-active placebo pill formulation

Treatment groups

104 Participants

are divided into 2 treatment groups

Group A: Oral Fosamprenavir pillsExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Reflux Symptom Index (RSI)

The absolute change from baseline (i.e., Pretreatment) in symptom severity as indicated by RSI Score over time, with the primary treatment comparison at Week 12 (End of Treatment Visit)

Time frame