Ambroxol Spray Sore Throat Study

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pharyngitis; Pain

Treatments: Drug: Ambroxol Spray; Drug: Placebo Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT01361802

18.504

Details and patient eligibility

About

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.

Enrollment: 494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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494 participants in 4 patient groups, including a placebo group

Ambroxol Spray 2.5mg

Active Comparator group

Description:

Ambroxol Spray Low Dose

Treatment:

Drug: Ambroxol Spray

Drug: Ambroxol Spray

Drug: Ambroxol Spray

Ambroxol Spray 5mg

Active Comparator group

Description:

Ambroxol Spray Medium Dose

Treatment:

Drug: Ambroxol Spray

Drug: Ambroxol Spray

Drug: Ambroxol Spray

Ambroxol Spray 10mg

Active Comparator group

Description:

Ambroxol Spray High dose

Treatment:

Drug: Ambroxol Spray

Drug: Ambroxol Spray

Drug: Ambroxol Spray

Placebo Spray

Placebo Comparator group

Description:

Placebo Spray

Treatment:

Drug: Placebo Spray