Omeprazole + Lifestyle Therapy for Laryngopharyngeal Reflux

(MVP Trial)

Overseen By Lorijane Robles

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Diego

Must not be taking: Acid suppressants

Disqualifiers: Foregut surgery, Achalasia, Tobacco, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treat laryngopharyngeal reflux (LPR), a condition causing throat issues like coughing and a hoarse voice. Participants will receive either the usual treatment with medication (such as omeprazole, an acid-reducing drug) or a more comprehensive plan. This plan includes medication or a placebo, therapy with a speech expert, and lifestyle changes. Researchers aim to determine if this new plan improves outcomes compared to the usual treatment. Individuals with throat symptoms for over two months who are not currently taking acid-reducing medication might be suitable for this study. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

Will I have to stop taking my current medications?

Participants must stop taking acid suppression medications for at least 2 weeks before joining the trial.

What is the safety track record for omeprazole and the lifestyle therapy used in this trial?

Research has shown that omeprazole, the treatment under study, is generally well-tolerated. In clinical trials involving 3,096 patients worldwide, omeprazole was used without major safety issues. The FDA has already approved this medication for treating conditions caused by excess stomach acid, such as ulcers and certain types of esophagitis (inflammation of the esophagus). Since omeprazole is being studied in a Phase 4 trial, it is already approved for use, indicating its safety for most people.

While taking omeprazole, some individuals might experience mild side effects like headaches, stomach pain, or nausea, but these do not occur in everyone. Overall, evidence indicates that omeprazole is considered safe for many users. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores a comprehensive approach to treating laryngopharyngeal reflux (LPR) by combining medication with lifestyle modifications. Unlike standard treatments that primarily rely on proton pump inhibitors (PPIs) alone, this trial includes Laryngeal Recalibration Therapy (LRT) with a speech language pathologist to specifically target laryngeal symptoms through mechanical and cognitive guidance. This dual approach aims to not only address acid reflux but also improve voice production and breath coordination, offering a more holistic solution to managing LPR.

What evidence suggests that this trial's treatments could be effective for laryngopharyngeal reflux?

Research has shown that omeprazole, a medication that reduces stomach acid, effectively eases symptoms of gastroesophageal reflux disease (GERD). It is commonly used to address throat symptoms related to laryngopharyngeal reflux (LPR). In this trial, participants in the Mechanism Guided Strategy arm may receive Laryngeal Recalibration Therapy (LRT) alongside omeprazole if reflux monitoring aligns with GERD. LRT has demonstrated promising results, with about 85% of patients with long-term throat symptoms experiencing improvement after the therapy. This combination of medication and specialized therapy could offer better relief for LPR symptoms compared to standard treatments. Meanwhile, participants in the Usual Care Strategy arm will receive a double dose of omeprazole and lifestyle counseling as part of the study's active control group. ^{6 7 8 9 10}

Who Is on the Research Team?

Rena Yadlapati, MD

Principal Investigator

UC San Diego Health

Are You a Good Fit for This Trial?

Adults aged 18-89 with chronic throat symptoms like cough, hoarseness, and acid reflux, who have been off acid suppression therapy for at least two weeks. They must be undergoing standard evaluation for LPR including an EGD and reflux monitoring.

Inclusion Criteria

I am between 18 and 89 years old.

I haven't taken acid suppression medication for at least 2 weeks.

I have had symptoms like coughing or voice changes for more than 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo an 8-week blinded study phase with randomization to either Mechanism Guided Strategy or Usual Care Strategy, including taking an oral capsule daily and attending 3 in-person visits.

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including transitioning back to clinical care.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omeprazole

Trial Overview The trial is testing a new multidisciplinary approach called Mechanism Guided Strategy against the usual care strategy involving PPI therapy (Omeprazole). Participants will take part in an 8-week study phase with random assignment to one of these strategies.

How Is the Trial Designed?

Group I: Usual Care Strategy Active Control 2 Interventions

1\) an 8-week course of double dose PPI and 2) lifestyle counseling. This represents the control group receiving usual care and will serve as the study's active control group. In order to maintain group concealment, subjects will receive counseling from a study investigator on standard lifestyle modifications recommended for GERD at intervals mirroring that of the mechanism guided strategy: week 1, week 4, and week 8 which is also reflective of standard recommended follow-up and counseling in GERD management.

Group II: Mechanism Guided Strategy Active Control 3 Interventions

1\) 8-week course of double dose PPI or placebo; 2) Laryngeal Recalibration Therapy (LRT) with speech language pathologist (SLP). Subjects will receive PPI if their reflux monitoring is consistent with GERD and placebo if it is not consistent with GERD. SLP will administer LRT: LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms. 1. Mechanical Guidance: The SLP will guide subjects through laryngeal suppression, changing voice production, and improving breath coordination. 2. Cognitive Guidance: The SLP will guide subjects through relaxation and conceptualization changes. 3. Lifestyle Recommendations: In addition to receiving LRT, subjects will be counseled on typical lifestyle recommendations for GERD, detailed in the Usual Care Strategy below.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38656937/

Laryngeal Recalibration Therapy Improves ... - PubMed The aim of this study was to assess symptom response to LRT among patients with chronic laryngopharyngeal symptoms undergoing evaluation of gastroesophageal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11534515/

Laryngeal Recalibration Therapy Improves ... The majority (85%) of patients referred for evaluation of laryngopharyngeal reflux disease that underwent laryngeal recalibration therapy experienced symptom ...

3. ddw.digitellinc.com ddw.digitellinc.com/p/s/laryngeal-recalibration-therapy-results-in-symptom-improvement-for-patients-with-laryngeal-symptoms-and-gastroesophageal-reflux-disease-6205

LARYNGEAL RECALIBRATION THERAPY RESULTS IN ... Following therapy 74% of participants reported improvement in laryngeal symptoms (Figure). Specifically, 10/11 (91%) with isolated laryngeal ...

4. journals.lww.com journals.lww.com/ajg/abstract/9900/laryngeal_recalibration_therapy_improves.1134.aspx?Ppt=Article%7Cajg:9900:00000:01134%7C10.14309/ajg.0000000000002839%7C

Laryngeal Recalibration Therapy Improves ... Overall, 55 participants (85%) met criteria for symptom response. Specifically, symptom response was similar between those with isolated laryngopharyngeal ...

5. researchgate.net researchgate.net/publication/380073031_Laryngeal_Recalibration_Therapy_Improves_Laryngopharyngeal_Symptoms_in_Patients_With_Suspected_Laryngopharyngeal_Reflux_Disease

Laryngeal Recalibration Therapy Improves ... Overall, 55 (85%) participants met criteria for symptom response. Specifically, symptom response was similar between those with isolated laryngopharyngeal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9012673/

An Update on Current Treatment Strategies for ... In another study of 32 subjects with LPR symptoms despite PPI therapy, 53% met symptom response (>50% improvement in RSI from baseline) with lansoprazole 15mg ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf

Prilosec Label - accessdata.fda.gov The safety data described below reflects exposure to. PRILOSEC Delayed-Release Capsules in 3096 patients from worldwide clinical trials (465 patients from US ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/omeprazole-oral-route/description/drg-20066836

Omeprazole (oral route) - Side effects & dosage Omeprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat gastric and duodenal ulcers, erosive esophagitis ...

9. aijoc.com aijoc.com/doi/10.5005/jp-journals-10003-1186

Evaluation of Omeprazole in the Treatment ... ABSTRACT. Aims: To assess efficacy and safety of omeprazole in laryngitis due to laryngopharyngeal reflux disease (LPRD).

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2503658/

Management of laryngopharyngeal reflux with proton pump ... Data from these trials show that PPI therapy is no more effective than placebo in producing symptom relief in patients suspected of LPR. Symptoms, laryngoscopic ...