TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms

Not Applicable

Completed

• Conditions: Topic: Ear, nose and throat; Respiratory; Subtopic: Ear (all Subtopics); Disease: Ear, nose & throat

• Registration Number: ISRCTN38578686
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27036555 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33492208/ results (added 26/01/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35338049/ Cross-sectional study (added 28/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-17
• Study Completion: 2017-10-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

1. Referred with a persistent (over six weeks) primary throat symptom - globus, hoarseness, throat clearing, throat discomfort, choking spasms, excess mucus/postnasal drip.
2. Informed consent to participate in entry screen.
3. Score over 10 on the non-heartburn items of the Respiratory Symptoms Index.
4. Patient has provided written informed consent for participation in the study prior to any study-specific procedures after reading the appropriate information and the required cooling off period has ensued
Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

1. Those with an RSI score excluding the lower GI item of <10.
2. Patients who are not willing to undergo flexible endoscopy could not by definition be included.
3. Inability to complete the relevant questionnaires.
4. Patients under 18 years old.
5. Endoscopic evidence of specific laryngopharyngeal pathology that would ordinarily be treated by surgical intervention or be investigated by specific investigations. This would include suspected neoplasia/dysplasia, prominent Reinke's oedema or unilateral vocal fold polyp, vocal cord palsy and rarities such as amyloid, Wegener's, sarcoid.
6. Confirmed or likely, current or prior malignancy of head and neck or oesophagus.
7. Performing voice user.
8. Pregnant or lactating woman. Woman of child bearing potential must be using adequate contraception.
9. Currently on acid suppressant, acid neutralisers and alginates and unwilling to discontinue for 4 weeks pre study washout period.
10. Prior adverse reaction to proton pump inhibitor.
11. Severe hepatic dysfunction.
12. Patients taking clopidogrel or Warfarin.
13. Patients taking Phenytoin.
14. Patients taking systemic antifungal treatment (specifically itraconazole, ketoconazole, posaconazole and voriconazole).
15. HIV positive/Patients taking Antiviral medications (atazanavir, nelfinavir, raltegravir, saquinavir, tipranavir).
16. Patients taking digoxin, cyclosporine, methotrexate, erlotinib, lapatinib, tacrolimus, sucralfate, escitalopram, fluvoxamine, St Johns wort, clozapine, Ulipristal or Cilostazol.
17. Previous participation in this study.
18. Use of other investigational study drugs within 30 days prior to study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic response measured using the Total Reflux Symptom Index (RSI) at 16 weeks/4 months in the treatment and placebo groups