Phase 3 N=249 Randomized Triple-blind Treatment

Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat

Pharyngitis

Bottom Line

View on ClinicalTrials.gov: NCT00525044 ↗

Enrolled (actual)

249

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Sum of Pain Intensity Difference (SPIDnorm)-Time-weighted Average of the Pain Intensity Difference (PID) From Pre-dose Baseline Over the First 3 Hours After the First Lozenge Expressed as a Ratio of the Pre-dose Baseline — -0.40; -0.34 ratio — p=0.0156

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ambroxol (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Sum of Pain Intensity Difference (SPIDnorm)-Time-weighted Average of the Pain Intensity Difference (PID) From Pre-dose Baseline Over the First 3 Hours After the First Lozenge Expressed as a Ratio of the Pre-dose Baseline	-0.40; -0.34	0.0156 sig
SECONDARY Pain Intensity (PI) as Rated on a 6-point VRS by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge	2.9; 3.1; 2.6; 2.8; 2.3; 2.7	0.1280
SECONDARY Pain Intensity Difference From Pre-dose Baseline (PID) as Rated on a 6-point Verbal Rating Scale (VRS) by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge	-1.1; -1.0; -1.4; -1.2; -1.8; -1.4	0.1280
SECONDARY Assessment of Redness of the Pharyngeal Mucosa by the Investigator on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation	0.0; 0.8; 12.1; 12.8; 53.2; 50.4	0.9939
SECONDARY Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation	13.7; 8.0; 58.1; 52.0; 19.4; 18.4	0.0343 sig

Summary

The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis.

Eligibility Criteria

Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance by the patient seems guaranteed.
Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate).
First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already.
Counting of white blood cell in blood routine examination exceeds 10?109/L.
Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.
Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage).
Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet.
Previous and/or existing tumour condition.
Pregnancy and/or breast-feeding.
Alcohol, and/or drug abuse.
Simultaneous participation in another clinical trial.

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Data sourced from ClinicalTrials.gov (NCT00525044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.