Lexiva for Laryngopharyngeal Reflux

(FLUTTER Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of the drug Lexiva (fosamprenavir) for treating laryngopharyngeal reflux (LPR), a condition that causes chronic coughing, throat clearing, and hoarseness. Researchers believe Lexiva might help because it targets pepsin, an enzyme contributing to these symptoms. The trial will compare Lexiva to a placebo (a pill with no active drug) over 12 weeks. People diagnosed with moderate to severe LPR who haven't found relief with other treatments might be a good fit.

As a Phase 2 trial, this research focuses on measuring how well the treatment works in an initial, smaller group of people.

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.

Is there any evidence suggesting that Lexiva is likely to be safe for humans?

Research has shown that fosamprenavir, a drug typically used for HIV, might be safe for treating laryngopharyngeal reflux (LPR). Some studies found that patients taking fosamprenavir experienced fewer cases of LPR compared to others, suggesting the drug could be effective without causing many new issues.

One study on inhaled fosamprenavir found it to be safe, as it did not cause many negative side effects. Although this study used a different form of the medication, the results are encouraging for its use in treating LPR.

Fosamprenavir already has FDA approval for HIV treatment, which provides some confidence in its safety. However, since this trial tests the drug for a new condition, monitoring remains necessary to ensure it is well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for LPR?

Unlike the standard treatments for laryngopharyngeal reflux, which often include lifestyle changes and medications like proton pump inhibitors (PPIs) to reduce stomach acid, Lexiva uses a different approach. Lexiva, also known as fosamprenavir, is an antiviral medication that researchers believe could offer relief through a unique mechanism that isn't focused on acid suppression. By targeting different pathways, Lexiva may provide an alternative for patients who haven't found success with traditional treatments. Researchers are excited about the potential for Lexiva to offer a new solution for managing this challenging condition.

What evidence suggests that Lexiva might be an effective treatment for LPR?

Research has shown that fosamprenavir, also known as Lexiva, might help treat laryngopharyngeal reflux (LPR) by targeting pepsin, an enzyme linked to throat inflammation. Early studies found that some HIV medications, including fosamprenavir, blocked pepsin and reduced LPR symptoms. People taking these drugs for HIV reported fewer LPR problems compared to those not taking them. This trial will test fosamprenavir's effectiveness for LPR, with participants receiving either oral fosamprenavir pills or a placebo. These findings strongly support testing its effectiveness for LPR, especially for patients who haven't improved with other treatments. ^{1 2 3 4 5}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04383262

Study Details | NCT04383262 | Fosamprenavir for ... Routine clinical outcome measures for LPR (Reflux Symptom Index, Reflux Finding Score, Voice Handicap Index) will be documented pre- and post-treatment with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10866582/

Inhaled fosamprenavir for laryngopharyngeal reflux Local delivery by inhalation could reduce dosing and was shown effective at 1/20th of the oral dose. This study makes progress toward a ...

3. ctv.veeva.com ctv.veeva.com/study/lexiva-for-the-treatment-of-lpr

Fosamprenavir for Laryngopharyngeal Upper Airway Tissue ... A 12-week randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of fosamprenavirvpills for LPR.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38362183/

Inhaled fosamprenavir for laryngopharyngeal reflux A 4-week pre-GLP study supports the safety of inhaled FOS. A formal GLP assessment is underway to support a phase I clinical trial of an FOS DPI for LPR.

5. withpower.com withpower.com/trial/phase-3-laryngopharyngeal-reflux-6-2021-686b9

Lexiva for Laryngopharyngeal Reflux (FLUTTER Trial) This trial is testing Lexiva, an HIV drug, to help patients with moderate/severe LPR who haven't responded to other treatments.