Persistent throat symptoms Ear, Nose and Throat
Conditions
Interventions
Patients that have been referred to the Ear, Nose and Throat or Speech and Language Therapy department will be invited to take part in the trial and if interested in taking part will be consented remo
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years old and over 2. = 6-week history of persistent throat symptoms (hoarse voice, lump in throat sensation, throat clearing, cough, post-nasal secretions/catarrh, throat discomfort) as evidenced by a total RSI score omitting the ninth item (heartburn symptoms [HB] “heartburn, chest pain, indigestion or stomach acid coming up” – i.e., RSI – HB) = 13 3. Ability to comprehend trial information and complete trial questionnaires 4. Willing and able to provide informed consent prior to any trial procedures taking place
Exclusion criteria
Exclusion criteria: 1. Any symptoms that meet the NICE guidance for a two-week wait for suspected head and neck cancer referral, i.e., persistent unexplained hoarseness or unexplained neck lump. 2. Any symptoms that when entered into the head and neck cancer risk calculator (ORLHealth.com | HaNC-RC v2, 2019) lead to a recommended urgent suspected cancer referral 3. Prior to the screening, intake of: 3.1. Systemic glucocorticosteroids within 28 days of screening 3.2. Prokinetics (e.g., cisapride) or drugs with prokinetic function, such as macrolide antibiotics, during the preceding 5 days and initiated in the previous 2 weeks of screening 3.3. Anticholinergic drugs, sucralfate or any other drugs that in the investigator’s opinion may affect the baseline measurements for the patient within 7 days of screening 4. Female participants with a known pregnancy 5. Known chronic kidney diseases. Patients with a history of chronic kidney disease will be specifically asked about: reduced kidney function, controlled potassium diet, hypophosphatemia, phenylketonuria, hypercalcaemia, nephrocalcinosis, recurrent calcium containing renal calculi 6. Patients with known or suspected hypersensitivity to the active substances (sodium alginate, potassium hydrogen carbonate), or active substance excipients (methyl parahydroxybenzoate (E128), propyl parahydroxybenzoate (E216), sodium hydroxide, saccharin sodium, carbomer, calcium carbonate) or placebo excipient ingredients (hydrogenated glucose syrup, xanthan gum, titanium dioxide, caramel) 7. Administration of an Investigational Medicinal Product within 30 days of the first dose of IMP 8. Any current or prior head and neck or gastroesophageal malignancy 9. Current or prior malignancy not in complete remission within 3 years of screening with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix 10. Inability, in the opinion of the investigator, to be able to complete the clinical trial visits or procedures 11. Any condition that, in the opinion of the investigator, would exclude the patient from participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant-reported symptoms measured using the Reflux Symptom Index (RSI) questionnaire at the end of 8 weeks of treatment with liquid alginate (Gaviscon Advance) or placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Participant-reported symptoms measured using the Reflux Symptom Index (RSI) questionnaire subscales and the Comprehensive Reflux Symptom Score (CReSS) questionnaire at the end of 8 weeks of treatment with liquid alginate or placebo 2. Participant-reported symptoms measured using the RSI questionnaire with and without heartburn at 2, 4 and 6 weeks of treatment with liquid alginate or placebo 3. Patient-reported trial medication compliance measured by counting patient-reported medication levels at the end of 8 weeks of trial treatment 4. Participant view of trial treatment received measured by the direct question at the end of 8 weeks of trial treatment 5. Participant-reported satisfaction with the trial measured by direct question and satisfaction questionnaire at the end of 8 weeks of trial treatment | — |
Countries
England, United Kingdom
Contacts
Public ContactNewcastle Clinical Trials Unit
Outcome results
None listed