Persistent throat symptom - globus, hoarseness, throat clearing, throat discomfort, choking spasms, excess mucus/postnasal drip, otherwise unexplained night time cough of choking.
Conditions
Interventions
Trade Name: Lansoprazole 30 mg Gastro-Resistant Capsules
Product Name: Lansoprazole 30mg gastro-resistant capsules
Pharmaceutical Form: Capsule
INN or Proposed INN: Lansoprazole
CAS Number: 103577-45-
Sponsors
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the symptomatic response in patients with persistent throat symptoms at the end of 4 months' therapy of treatment with lansoprazole versus placebo.;Secondary Objective: 1. To explore the feasibility of study recruitment by means of an internal pilot trial rehearsal whose data will be included in the main data for analysis. 2. To compare the end of 4 months' treatment symptom response with those at 12 months. 3. To determine the utility of the Reflux Symptoms Index (RSI) questionnaire, the Comprehensive Reflux Symptom Score (CReSS) questionnaire and subscales, endolaryngeal examination findings as scored by the Reflux Finding Score, and patient demographics including age; gender; smoking; Body Mass Index as potential baseline determinants of treatment response. 4. To compare the patient reported side effects and compliance with treatment and use of any other over-the-counter medication use in both arms. 5. To compare changes in disease-specific quality of life (LPR-HRQL) in the two arms.;Primary end point(s): The RSI remains the ‘area standard’, and despite well–rehearsed limitations remains our chosen primary outcome in the present proposal. The change in Reflux Symptom Index (RSI) at 4 months in the treatment and placebo groups in an intention to treat analysis. The 9 item RSI allows comparison with previous studies as it offers ten years’ of comparative data in the literature. We plan however to report both the total score (0-45) and the score omitting the heartburn item (0-40), which we and others note can skew the results in favour of PPI in past small trials. Inclusion of the total RSI aligns our output with other publications which have not taken separate account of the RSI heartburn item. Our proposed analysis will also address the issue of presentation of simple mean end scores in other papers, with wide deviations and often with a mean out with the normal reference range. We shall further explore this outcome according to our stra | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (i) To explore the feasibility of study recruitment by means of an internal pilot trial rehearsal whose data will be included in the main data for analysis (ii) To compare the end of 4 months (16 weeks) treatment symptom responses with those at 12 months (iii) To determine the utility of the Reflux Symptom Index (RSI) questionnaire, the Comprehensive Reflux Symptom Score (CReSS) questionnaire items and subscales, endolaryngeal examination findings as scored by the Reflux Finding Score, and patient demographics including age; gender; smoking; Body Mass Index (43-45) as potential baseline determinants of treatment response. (iv) To compare the patient reported side effects and compliance with treatment and use of any other over-the-counter medication use in both arms. (v) To compare changes in disease-specific quality of life (LPR-HRQL) in the two arms.;Timepoint(s) of evaluation of this end point: Four months (16 weeks) and 12 months | — |
Countries
United Kingdom
Contacts
Public ContactJanet Wilson
Newcastle University
Outcome results
None listed