Ambroxol Spray Sore Throat Study

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Pharyngitis
• Intervention / Treatment: Drug: Ambroxol Spray; Drug: Ambroxol Spray; Drug: Ambroxol Spray; Drug: Placebo Spray

• Study Type: Interventional
• Enrollment (Actual): 494
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • Bloemfontein, South Africa
    • 18.504.27015 Boehringer Ingelheim Investigational Site
  • Cape Town, South Africa
    • 18.504.27005 Boehringer Ingelheim Investigational Site
  • Cape Town, South Africa
    • 18.504.27011 Boehringer Ingelheim Investigational Site
  • Cape Town, South Africa
    • 18.504.27013 Boehringer Ingelheim Investigational Site
  • Cape Town, South Africa
    • 18.504.27014 Boehringer Ingelheim Investigational Site
  • Durban, South Africa
    • 18.504.27008 Boehringer Ingelheim Investigational Site
  • Durban, South Africa
    • 18.504.27010 Boehringer Ingelheim Investigational Site
  • Johannesburg, South Africa
    • 18.504.27001 Boehringer Ingelheim Investigational Site
  • Klipspruit West, South Africa
    • 18.504.27004 Boehringer Ingelheim Investigational Site
  • Krugersdorp, South Africa
    • 18.504.27003 Boehringer Ingelheim Investigational Site
  • Lenasia, South Africa
    • 18.504.27002 Boehringer Ingelheim Investigational Site
  • Newtown, South Africa
    • 18.504.27006 Boehringer Ingelheim Investigational Site
  • Paarl, South Africa
    • 18.504.27012 Boehringer Ingelheim Investigational Site
  • Pretoria, South Africa
    • 18.504.27007 Boehringer Ingelheim Investigational Site
  • Sydenham, South Africa
    • 18.504.27009 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Sore throat due to acute pharyngitis (not more than 72 hours);
2. Score of 6 or greater on an 11-point pain intensity numerical rating scale;
3. Willingness to remain at the study centre for one hour following the first dose of study medication and return one to three days later.
4. 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:

1. Known allergy to and/or hypersensitivity to ambroxol, sorbitol, or Acetaminophen;
2. Patients with drug dependence and/or alcohol abuse;
3. Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 2 hours;
4. Use of any analgesic/anti-pyretic within last 4 hours;
5. Use of any "cold medication" (e.g. decongestant, antihistamine, expectorant, anti-tussive) within last eight hours;
6. Use of an antibiotic for an acute illness within last 24 hours;
7. Use of inhaled steroids or beta-agonists on a continuous basis during the last week;
8. Use of any investigational therapy (including a marketed drug taken for an investigational indication) within last 30 days
9. Any sign of mouth-breathing due to nasal congestion;
10. Cough that causes throat discomfort;
11. Active pulmonary disease such as bronchopneumonia;
12. Pregnant, lactating or breastfeeding women,
13. 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.
14. Patients who have previously enrolled in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ambroxol Spray 2.5mg; Ambroxol Spray Low Dose	Drug: Ambroxol Spray; low dose Ambroxol Spray; Drug: Ambroxol Spray; medium dose Ambroxol Spray; Drug: Ambroxol Spray; high dose Ambroxol Spray
Active Comparator: Ambroxol Spray 5mg; Ambroxol Spray Medium Dose	Drug: Ambroxol Spray; low dose Ambroxol Spray; Drug: Ambroxol Spray; medium dose Ambroxol Spray; Drug: Ambroxol Spray; high dose Ambroxol Spray
Active Comparator: Ambroxol Spray 10mg; Ambroxol Spray High dose	Drug: Ambroxol Spray; low dose Ambroxol Spray; Drug: Ambroxol Spray; medium dose Ambroxol Spray; Drug: Ambroxol Spray; high dose Ambroxol Spray
Placebo Comparator: Placebo Spray	Drug: Placebo Spray; Placebo Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 27, 2011

Study Record Updates

• Last Update Posted (Estimate): May 16, 2014
• Last Update Submitted That Met QC Criteria: April 30, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Respiratory System Agents; Expectorants; Ambroxol
• Other Study ID Numbers: 18.504