Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux
Phase 4
Completed
- Conditions
- Chronic Posterior Laryngitis (CPL)
- Interventions
- Drug: Placebo
- Registration Number
- NCT00628667
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study looks at how effective acid suppression therapy is on symptoms associated with chronic posterior laryngitis (CPL) in patients with documented pharyngeal acid reflux.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- One or more of the following symptoms present for at least 3 consecutive months: throat clearing, cough, globus, sore throat, or hoarseness.
- Patients must complete a run-in diary card, and this will be looked at to ensure met the inclusion criteria.
- Must have a total score of 5 or more on the Chronic Posterior Laryngitis Index (CPLI) grading system.
Exclusion Criteria
- A number of diseases / conditions would preclude a patient from taking part in the study, as listed in the protocol.
- If the patient is on certain medications this will also preclude them from taking part.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Esomeprazole - 2 Placebo -
- Primary Outcome Measures
Name Time Method Daily diary cards and investigator symptom assessment to evaluate the efficacy of acid suppression therapy on symptoms associated with chronic posterior laryngitis (CPL) in patients without documented pharyngeal acid Dialy diary cards, investigator assessments, laryngoscopy at week 16
- Secondary Outcome Measures
Name Time Method Daily diary cards and investigator symptom assessment throughout to evaluate the efficacy of acid suppression therapy on resolution of signs of CPL at weeks 8 and 16 in patients without documented pharyngeal acid reflux. Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16 Quality of life Questionnaire Quality of life questionnaire completed at screening and week 16 To evaluate the safety and tolerability by collecting an ongoing record of adverse events. Ongoing to week 16.