Ambroxol Spray Sore Throat Study

Study Overview
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Brief Summary
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The development of a new Ambroxol spray formulation for the treatment of sore throat pain associated with acute pharyngitis requires an initial phase II study to be conducted in order to select the most appropriate dose for pain relief.

Official Title
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A Multi-centre, Randomised, Double-blind, Placebo Controlled Parallel Group, Dose Finding Study to Assess the Efficacy and Safety of Ambroxol Spray (2.5mg, 5mg or 10mg) Versus Placebo for the Temporary Relief of Sore Throat Pain in Patients With Acute Pharyngitis

Conditions
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Pharyngitis, Pain

Intervention / Treatment
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* Drug: Ambroxol Spray
* Drug: Ambroxol Spray
* Drug: Ambroxol Spray
* Drug: Placebo Spray


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Sore throat due to acute pharyngitis (not more than 72 hours); Score of 6 or greater on an 11-point pain intensity numerical rating scale; Willingness to remain at the study centre for one hour following the first dose of study medication and return one to three days later. Willing to take nothing by mouth except study medication for three hours following the first intake of study medication. Patients must also not smoke during this time period. Exclusion criteria: Known allergy to and/or hypersensitivity to ambroxol, sorbitol, or Acetaminophen; Patients with drug dependence and/or alcohol abuse; Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 2 hours; Use of any analgesic/anti-pyretic within last 4 hours; Use of any cold medication (e.g. decongestant, antihistamine, expectorant, anti-tussive) within last eight hours; Use of an antibiotic for an acute illness within last 24 hours; Use of inhaled steroids or beta-agonists on a continuous basis during the last week; Use of any investigational therapy (including a marketed drug taken for an investigational indication) within last 30 days Any sign of mouth-breathing due to nasal congestion; Cough that causes throat discomfort; Active pulmonary disease such as bronchopneumonia; Pregnant, lactating or breastfeeding women, Any medical or psychiatric condition which, in the opinion of the investigator, could increase the risks associated with participation in an investigational study or affect compliance with the protocol. Patients who have previously enrolled in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ambroxol Spray 2.5mg<br>Ambroxol Spray Low Dose | Drug: Ambroxol Spray<br>* low dose Ambroxol Spray<br>|
| Active Comparator: Ambroxol Spray 5mg<br>Ambroxol Spray Medium Dose | Drug: Ambroxol Spray<br>* medium dose Ambroxol Spray<br>|
| Active Comparator: Ambroxol Spray 10mg<br>Ambroxol Spray High dose | Drug: Ambroxol Spray<br>* high dose Ambroxol Spray<br>|
| Placebo Comparator: Placebo Spray<br>Placebo Spray | Drug: Placebo Spray<br>* Placebo Spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the time-weighted average of the pain intensity difference (PID) from pre-dose baseline over the first two hours after the first spray application expressed as a ratio of the pre-dose baseline (SPIDnorm0-2h). |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 3 hours after the first spray application and the corresponding SPIDnorm0-3h |  | 3 hours | 
| Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 4, 6, 12 and 24 hours after the first spray application and the corresponding SPIDnorm0-24h |  | 4, 6, 12 and 24 hours | 
| Patient assessment of efficacy at 3 and 24 hours after the first spray application will be assessed on a 5-point verbal rating scale. |  | 3 and 24 hours |