Ambroxol Spray Sore Throat Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01361802
First received: May 16, 2011
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Pharyngitis
Pain
Drug: Ambroxol Spray
Drug: Placebo Spray
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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). [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 4, 6, 12 and 24 hours ] [ Designated as safety issue: No ]
  • Patient assessment of efficacy at 3 and 24 hours after the first spray application will be assessed on a 5-point verbal rating scale. [ Time Frame: 3 and 24 hours ] [ Designated as safety issue: No ]

Enrollment: 494
Study Start Date: May 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ambroxol Spray 2.5mg
Ambroxol Spray Low Dose
Drug: Ambroxol Spray
low dose Ambroxol Spray
Active Comparator: Ambroxol Spray 5mg
Ambroxol Spray Medium Dose
Drug: Ambroxol Spray
medium dose Ambroxol Spray
Active Comparator: Ambroxol Spray 10mg
Ambroxol Spray High dose
Drug: Ambroxol Spray
high dose Ambroxol Spray
Placebo Comparator: Placebo Spray
Placebo Spray
Drug: Placebo Spray
Placebo Spray

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361802

Locations
South Africa
18.504.27015 Boehringer Ingelheim Investigational Site
Bloemfontein, South Africa
18.504.27005 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
18.504.27013 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
18.504.27011 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
18.504.27014 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
18.504.27008 Boehringer Ingelheim Investigational Site
Durban, South Africa
18.504.27010 Boehringer Ingelheim Investigational Site
Durban, South Africa
18.504.27001 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
18.504.27004 Boehringer Ingelheim Investigational Site
Klipspruit West, South Africa
18.504.27003 Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa
18.504.27002 Boehringer Ingelheim Investigational Site
Lenasia, South Africa
18.504.27006 Boehringer Ingelheim Investigational Site
Newtown, South Africa
18.504.27012 Boehringer Ingelheim Investigational Site
Paarl, South Africa
18.504.27007 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
18.504.27009 Boehringer Ingelheim Investigational Site
Sydenham, South Africa
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01361802     History of Changes
Other Study ID Numbers: 18.504
Study First Received: May 16, 2011
Last Updated: April 30, 2014
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Pharyngitis
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases
Ambroxol
Expectorants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014