Trial of Proton Pump Inhibitors in Throat Symptoms

Phase 1

• Conditions: Persistent throat symptom - globus, hoarseness, throat clearing, throat discomfort, choking spasms, excess mucus/postnasal drip, otherwise unexplained night time cough of choking.; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2013-004249-17-GB
• Lead Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-13
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 332

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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 249
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 83

Exclusion Criteria

Those with an RSI score excluding the lower GI item of <10.

Patients who are not willing to undergo flexible endoscopy could not by definition be included.

Inability to complete the relevant questionnaires.

Patients under 18 years old.

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.

Confirmed or likely, current or prior malignancy of head and neck or oesophagus.

Performing voice user.

Pregnant or lactating woman. Woman of child bearing potential must be using adequate contraception.

Currently on acid suppressant, acid neutralisers and alginates and unwilling to discontinue for 4 weeks pre study washout period.

Prior adverse reaction to proton pump inhibitor.

Severe hepatic dysfunction.

Patients taking clopidogrel or Warfarin.

Patients taking Phenytoin.

Patients taking systemic antifungal treatment (specifically itraconazole, ketoconazole, posaconazole and voriconazole).

HIV positive/Patients taking Antiviral medications (atazanavir, nelfinavir, raltegravir, saquinavir, tipranavir).

Patients taking digoxin, cyclosporine, methotrexate, erlotinib, lapatinib, tacrolimus, sucralfate, escitalopram, fluvoxamine, St Johns wort, clozapine, Ulipristal or Cilostazol.

Previous participation in this study.

Use of other investigational study drugs within 30 days prior to study entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified