Extract

Background and study aims Laryngopharyngeal reflux, the backflow of acid into your oesophagus and into your throat and voice box, has been cited as a cause for a wide range of complaints. These include hoarsenss, a sensation of a lump in the throat, sore throats, chronic cough, and chronic throat clearing. There are no tests that can be done that reliably, in all patients, diagnose the condition and so medications are often given on the basis of the clinical history and physical examination findings. Patients are often given prolonged courses of proton pump inhibitors which suppress stomach acid (gastric acid) production, in an effort to improve symptoms. However, trials with proton pump inhibitors have shown little benefit over inactive medicine (placebo), but have often used small numbers of patients and have had shortcomings in the way the study was designed . A promising trial has shown the benefit of a liquid preparation, called an alginate, which binds to the damaging components of the stomach contents and helps to reduce the extent of backflow (reflux) of material into the gullet (oesophagus). Who can participate? We will enrol patients with laryngopharyngeal reflux who have been referred from their GP to hospital for an ENT specialist (otolaryngological) opinion. What does the study involve? The consenting patients will undergo a medical consultation including physical examination and will complete a questionnaire. A subgoup will undergo physiological testing and a surgical procedure to remove tissue for examination (small tissue biopsies) taken from the back of the throat under local anaesthetic in the clinic. They will then take a tablet medication once a day (either the genuine drug or a placebo) and a liquid preparation (either the medication or a placebo) four times per day. The tests will then be repeated up to 6 months after the initial consultation. Patients will be randomly allocated and will not know whether they are receiving the genuine drug or the placebo. What are the possible benefits and risks of participating? There is no therapeutic benefit from the placebo. There are no known significant side effects of 6 month treatment with these medications and they are the current treatment of choice prior to this study. Where is the study run from? The study will be run from Southampton Clinical Trials Unit and will include about 10 centres across the UK plus centres in Europe. When is the study starting and how long is it expected to run for? Recruitment to the trial will likely commence in January 2013 and is likely to continue until June 2015. Updated 10/09/2013: this trial has been stopped due to lack of staff/facilities/resources Who is funding the study? We are in the process of applying for funding from the National Institute for Health Research (UK). Who is the main contact? Mr Steven Frampton [email protected]

Inclusion criteria

• Laryngopharyngeal Reflux (LPR)

Links

• isrctn
• ictrp