Lexiva for Laryngopharyngeal Reflux

(FLUTTER Trial)

Recruiting at 1 trial location

Overseen By Ally Vandenberg, BSc

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Must not be taking: Investigational drugs

Disqualifiers: Age ≥ 65, Pregnancy, Polypharmacy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing Lexiva, an HIV drug, to help patients with moderate/severe LPR who haven't responded to other treatments. Lexiva works by blocking pepsin, which causes throat inflammation. The goal is to see if this drug can reduce LPR symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on five or more medications due to other health conditions, you may not be eligible to participate.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe LPR, a throat condition causing cough and hoarseness. Participants must have tried acid-reducing meds without success and be confirmed to have LPR by specific tests. It's not for those over 65, pregnant or nursing women, or people with certain GI diseases, past stomach surgeries, suspected cancer in the throat area, or on many other medications.

Inclusion Criteria

I have been diagnosed with laryngopharyngeal reflux (LPR).

My cancer has not returned for at least 11 months.

Your Respiratory Symptom Index score is 20 or more.

Exclusion Criteria

I am currently participating in another clinical trial.

Anticipated poor understanding or compliance of the study protocol

I have cancer in the upper part of my throat behind the nose.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Oral Fosamprenavir or placebo for 12 weeks

12 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lexiva

Trial Overview The study is testing Lexiva (an HIV drug) as a potential treatment for LPR by seeing if it can inhibit pepsin—a cause of inflammation in the throat. This will be a 12-week test where half the patients get Lexiva and half get a placebo. They'll measure symptoms before and after using questionnaires and saliva tests.

How Is the Trial Designed?

Group I: Oral Fosamprenavir pills Experimental Treatment 1 Intervention

FOS: 1,400 mg fosamprenavir calcium b.i.d. (AM/PM) for 12 weeks

Group II: Placebo Placebo Group 1 Intervention

Sodium Alginate: for 12 weeks.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+