Reflux Band for Acid Reflux in Lung Transplant Patients

(Reflux Band Trial)

Overseen By Vanessa Scheuble

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Sleep apnea, Head/neck surgery, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently being treated with another investigational medical device or drug.

What data supports the effectiveness of the treatment Reflux Band, Reza Band for acid reflux in lung transplant patients?

Research shows that antireflux surgery, which aims to prevent acid reflux, can improve lung function and survival in lung transplant patients. While the Reflux Band is not specifically mentioned, similar treatments that reduce reflux have been effective in this high-risk group. ^{1 2 3 4 5}

Is the Reflux Band safe for human use?

The Reflux Band, also known as the Reza Band, is an external device used to reduce acid reflux by compressing the upper esophageal sphincter (a muscle at the top of the esophagus). While the study focused on its effectiveness, it implies that the device is generally safe for human use as it is used alongside standard treatments for acid reflux. ^{6 7 8 9 10}

What makes the Reflux Band treatment unique for acid reflux in lung transplant patients?

The Reflux Band is unique because it is a non-drug treatment that works by applying gentle pressure to the throat to prevent acid from rising, unlike traditional medications that reduce stomach acid production or neutralize it. ^{11 12 13 14 15}

What is the purpose of this trial?

A prospective, open label, study designed to assess the affect of the Reflux Band® UES Assist Device (Reflux Band) on reflux in patients that have undergone lung transplantation.

Research Team

Manuel Amaris, MD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for lung transplant recipients who have acid reflux, as shown by tests before their transplant. They must understand and agree to the study's process and follow-up visits. Stable lung function after the transplant is required. People with recent head or neck surgery, thyroid disease, certain cancers, carotid artery disease, or a history of stroke can't join.

Inclusion Criteria

Patient must be willing and able to provide informed consent

My lung function has been stable since my last two doctor visits.

Abnormal pH impedence or esophagram or documented gastric reflux at pre-transplant evaluation

Exclusion Criteria

I am using a CPAP machine for my sleep apnea.

I have had a stroke or other brain blood vessel issues.

I have a thyroid condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Observation

Lung transplant patients are observed without the Reflux Band for four weeks

4 weeks

1 visit (in-person) at baseline

Treatment

Participants use the Reflux Band for four weeks

4 weeks

1 visit (in-person) at week 4

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at week 8

Treatment Details

Interventions

• Reflux Band

Trial Overview The study is testing the Reflux Band™ UES Assist Device on patients who've had a lung transplant to see if it helps control their acid reflux symptoms. It's an open-label trial where all participants will use the device and be monitored for its effects.

Participant Groups

Group I: Lung Transplant Patients Experimental Treatment 1 Intervention

For the first four weeks, lung transplant patients will not wear the Reflux Band. Use of the Reflux Band will subsequently commence in the next four weeks.

Reflux Band is already approved in United States, European Union for the following indications:

Approved in United States as Reflux Band for:

• Laryngopharyngeal reflux (LPR) disease

Approved in European Union as Reflux Band for:

• Laryngopharyngeal reflux (LPR) disease

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Somna Therapeutics, L.L.C.

Industry Sponsor

Trials

3

Recruited

140+

SOMNA THERAPEUTICS

Collaborator

Trials

1

Recruited

20+

Findings from Research

In a study of 53 lung transplant patients who underwent partial fundoplication, there was a trend suggesting a slower decline in lung function post-surgery, although this was not statistically significant.

The surgery significantly reduced acid exposure in the esophagus, with DeMeester scores dropping from a median of 45.8 to 1.8, indicating effective control of gastroesophageal reflux disease (GERD) after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of partial fundoplication for GERD-related allograft decline after lung transplantation. Kowalski, E., Smith, J., Zambito, G., et al.[2023]

In a study of 109 patients awaiting lung transplantation, 68% were found to have gastroesophageal reflux disease (GERD), highlighting a significant prevalence in this population.

Esophageal motility abnormalities were common, with 55% of patients showing a hypotensive lower esophageal sphincter and 47% having impaired esophageal peristalsis, indicating that symptoms alone are not reliable for diagnosing GERD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of distal and proximal gastroesophageal reflux in patients awaiting lung transplantation. Sweet, MP., Herbella, FA., Leard, L., et al.[2018]

In a study of 48 lung transplant recipients, late post-transplant antireflux surgery (ARS) was associated with a significantly higher risk of early allograft injury compared to ARS performed before or early after transplantation.

Both pre-transplant and early post-transplant ARS were found to be equally safe and effective in improving lung transplant outcomes, suggesting that addressing gastroesophageal reflux disease (GERD) before or shortly after transplantation can help protect the transplanted lung.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Both Pre-Transplant and Early Post-Transplant Antireflux Surgery Prevent Development of Early Allograft Injury After Lung Transplantation. Lo, WK., Goldberg, HJ., Wee, J., et al.[2018]

In a study of 188 lung transplant recipients, persistent use of proton pump inhibitors (PPIs) was associated with a significantly lower risk of acute or chronic rejection compared to those not using acid suppression therapy, indicating a protective effect of PPIs post-transplant.

The analysis suggested that PPIs may provide additional benefits beyond acid suppression, potentially offering anti-inflammatory effects that enhance allograft protection, as evidenced by a hazard ratio of 0.39 for rejection in patients using PPIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Pump Inhibitors Independently Protect Against Early Allograft Injury or Chronic Rejection After Lung Transplantation. Lo, WK., Goldberg, HJ., Boukedes, S., et al.[2018]

Gastroesophageal reflux disease (GERD) in lung transplant recipients is linked to higher rates of acute rejection, earlier chronic rejection, and increased mortality, highlighting the importance of managing this condition.

Total fundoplication is a safe and effective surgical option for treating GERD in lung transplant patients, helping to prevent early allograft dysfunction and improve overall survival, and should be part of a multidisciplinary perioperative care approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antireflux surgery in the setting of lung transplantation: strategies for treating gastroesophageal reflux disease in a high-risk population. Hartwig, MG., Appel, JZ., Davis, RD.[2019]

In a clinical trial with 31 participants, the Reflux Band device, when used alongside proton pump inhibitors (PPIs), significantly improved symptoms of laryngopharyngeal reflux (LPR), with 55% of participants meeting the primary endpoint after 4 weeks of combined treatment.

The study found that the mean reflux symptom index (RSI) score significantly decreased from 21.9 after PPI alone to 15.5 after using the Reflux Band with PPI, indicating enhanced efficacy of the device in reducing reflux symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux. Yadlapati, R., Pandolfino, JE., Greytak, M., et al.[2022]

Proton pump inhibitors (PPIs) are the most effective treatment for gastroesophageal reflux disease (GERD), but many patients still experience breakthrough symptoms and require additional medications like antacids.

New therapies are being developed to improve GERD treatment, including faster-acting agents, those that better control acid secretion, and medications that reduce transient lower esophageal sphincter relaxations (TLESRs), which could enhance symptom relief and healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New pharmacological agents for the treatment of gastroesophageal reflux disease. Vakil, N.[2018]

C-BLART (clip band ligation anti-reflux therapy) shows short-term efficacy in improving lower esophageal sphincter (LES) pressure and GERD symptoms in patients with refractory gastroesophageal reflux disease (GERD), with significant improvements noted after 6 months.

Despite some improvements in esophageal acid exposure and symptom scores, many patients still exhibited objective signs of GERD after treatment, indicating that while C-BLART is a promising option, it may not completely resolve the condition for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New treatment method for refractory gastroesophageal reflux disease (GERD): C-BLART (clip band ligation anti-reflux therapy)-a short-term study. Liu, S., Chai, N., Zhai, Y., et al.[2023]

Lesogaberan is rapidly absorbed when taken orally, reaching peak plasma concentration within 1-2 hours, and has a terminal half-life of 11 to 13 hours, indicating effective pharmacokinetics for potential symptom relief in gastroesophageal reflux disease.

The majority of lesogaberan is excreted through the kidneys, either as the unchanged drug or as metabolites, with no safety concerns reported during the study involving 10 healthy male subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic profile of lesogaberan (AZD3355) in healthy subjects: a novel GABA(B)-receptor agonist reflux inhibitor. Niazi, M., Skrtic, S., Ruth, M., et al.[2021]

Rabeprazole is a proton pump inhibitor that effectively treats acid-related disorders like GERD and duodenal ulcers, showing rapid relief of heartburn symptoms as early as day 1 in a 2-week placebo-controlled trial.

It has a unique mechanism of action that allows it to be effective at higher pH levels and is less affected by genetic variations in metabolism, making it a safe option with minimal side effects for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rabeprazole: a pharmacologic and clinical review for acid-related disorders. Dadabhai, A., Friedenberg, FK.[2019]

Amrubicin (AMR) demonstrated a 50% partial response rate in both chemotherapy-sensitive and chemotherapy-refractory relapsed small cell lung cancer (SCLC) patients, indicating its efficacy as a second-line treatment.

The treatment was associated with manageable side effects, including significant neutropenia in some patients, but no treatment-related deaths were reported, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome of amrubicin therapy according to the prior chemotherapy sensitivities of extensive small cell lung cancer. Mitsuoka, S., Kudoh, S., Kimura, T., et al.[2012]

Lurbinectedin received accelerated FDA approval for treating metastatic small cell lung cancer (SCLC) in patients who progressed after platinum-based chemotherapy, based on a study of 105 patients showing a 35% overall response rate and a median duration of response of 5.3 months.

This approval is significant as it is the first new treatment option for metastatic SCLC in over 20 years, particularly addressing the needs of patients with platinum-resistant disease, although it comes with warnings for potential side effects like myelosuppression and hepatotoxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer. Singh, S., Jaigirdar, AA., Mulkey, F., et al.[2022]

Lurbinectedin, approved by the FDA in June 2020 as ZEPZELCA, is the first systemic therapy specifically for Small Cell Lung Cancer (SCLC), highlighting its significance in cancer treatment.

The drug works by inhibiting the transcription of genes related to tumor growth, which helps to suppress tumor-associated macrophages and alter the tumor environment, making it a promising option for SCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Small Cell Lung Cancer with Lurbinectedin: A Review. Rajput, PS., Khan, SR., Singh, P., et al.[2022]

The combination of amrubicin (AMR) and carboplatin (CBDCA) showed an overall response rate (ORR) of 34% in 29 patients with refractory relapsed small-cell lung cancer (SCLC), indicating potential efficacy for this treatment regimen.

The treatment was generally well tolerated, with the most common severe side effect being neutropenia in 79% of patients, but only one case of febrile neutropenia, suggesting a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of amrubicin combined with carboplatin for refractory relapsed small-cell lung cancer: North Japan Lung Cancer Group Trial 0802. Kawashima, Y., Inoue, A., Sugawara, S., et al.[2014]

Lurbinectedin is a newly approved second-line treatment for small cell lung cancer (SCLC) that works by binding to DNA and disrupting critical cellular processes, showing a response rate of 35.2% in a trial of 105 patients who had previously received therapy.

While myelosuppression, particularly neutropenia, was the most common side effect, it was manageable, with only 5% of patients experiencing neutropenic fever, indicating a favorable safety profile compared to other treatments like topotecan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of lurbinectedin as a new second-line treatment option for small cell lung cancer. Patel, S., Petty, WJ., Sands, JM.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Outcomes of partial fundoplication for GERD-related allograft decline after lung transplantation. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The prevalence of distal and proximal gastroesophageal reflux in patients awaiting lung transplantation. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Both Pre-Transplant and Early Post-Transplant Antireflux Surgery Prevent Development of Early Allograft Injury After Lung Transplantation. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Proton Pump Inhibitors Independently Protect Against Early Allograft Injury or Chronic Rejection After Lung Transplantation. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Antireflux surgery in the setting of lung transplantation: strategies for treating gastroesophageal reflux disease in a high-risk population. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Upper Esophageal Sphincter Compression Device as an Adjunct to Proton Pump Inhibition for Laryngopharyngeal Reflux. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

New pharmacological agents for the treatment of gastroesophageal reflux disease. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

New treatment method for refractory gastroesophageal reflux disease (GERD): C-BLART (clip band ligation anti-reflux therapy)-a short-term study. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacokinetic profile of lesogaberan (AZD3355) in healthy subjects: a novel GABA(B)-receptor agonist reflux inhibitor. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Rabeprazole: a pharmacologic and clinical review for acid-related disorders. [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

Clinical outcome of amrubicin therapy according to the prior chemotherapy sensitivities of extensive small cell lung cancer. [2012]

12. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of Small Cell Lung Cancer with Lurbinectedin: A Review. [2022]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Phase II study of amrubicin combined with carboplatin for refractory relapsed small-cell lung cancer: North Japan Lung Cancer Group Trial 0802. [2014]

15. England pubmed.ncbi.nlm.nih.gov

An overview of lurbinectedin as a new second-line treatment option for small cell lung cancer. [2021]