Drug treatment of Laryngopharyngeal Reflux (LPR)
| ISRCTN | ISRCTN03482154 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03482154 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/09/2011
- Registration date
- 06/10/2011
- Last edited
- 10/09/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
Plain English Summary
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
steveframpton@doctors.org.uk
Contact information
Scientific
CRUK Senior Lecturer in Head and Neck Surgery
Cancer Sciences Division
Somers Cancer Research Building
MP824
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | International multi-centre randomised double-blinded placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of the efficacy of a Proton Pump Inhibitor (PPI) and / or alginate in the treatment of Laryngopharyngeal Reflux (LPR) in adult patients in secondary care |
| Study hypothesis | Proton pump inhibitors are widely prescribed in the National Health Service (NHS) for the treatment of LPR. The data for their efficacy is weak. A study has shown increased efficacy of alginate over no treatment for patients with LPR. We suspect that alginate, either alone or in combination with PPI will show increased efficacy over placebo. |
| Ethics approval(s) | Southampton Local Research Ethics Committee, approval pending as of 07/09/2011 |
| Condition | Laryngopharyngeal reflux (LPR) |
| Intervention | 1. Patients will receive omeprazole 40 mg or placebo once daily (OD) and 2. Sodium alginate and potassium bicarbonate (Gaviscon® advance) or placebo 5 ml four times a day (QDS) for 6 months Updated 10/09/2013: this trial has been stopped due to lack of staff/facilities/resources |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Omeprazole, sodium alginate and potassium bicarbonate (Gaviscon® advance) |
| Primary outcome measure | Improvement in validated symptom scores using standardised validated questionnaires. Time points of measurement 2, 4 and 6 months |
| Secondary outcome measures | 1. Laryngeal examination improvement (validated scoring system) at 2 and 6 months in a subgroup of patients 2. Physiological studies (pH / impedance) testing in a subgroup at 2 and 6 months 3. Tissue biopsy pre-treatment and at 2 and /or 6 months |
| Overall study start date | 01/01/2013 |
| Overall study end date | 01/06/2015 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 1500 |
| Participant inclusion criteria | All adult patients, aged 16 years and over referred from general practice to secondary care who following consultation with an Otolaryngological specialist have a working diagnosis for their symptoms of LPR |
| Participant exclusion criteria | 1. Children 2. Known or likely upper aerodigestive tract malignancy 3. Pregnancy 4. Known or suspected allergies to any medications used in the trial |
| Recruitment start date | 01/01/2013 |
| Recruitment end date | 01/06/2015 |
Locations
Countries of recruitment
- Belgium
- England
- United Kingdom
Study participating centre
SO16 6YD
United Kingdom
Sponsor information
University/education
University Road
Southampton
SO17 1BJ
England
United Kingdom
| Website | http://www.southampton.ac.uk/medicine |
|---|---|
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
