Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis (DELICIOUS)

A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial to Assess the Efficacy and Safety of Ambroxol Lozenges 20 mg (Hard Boiled Lozenges) Versus Placebo for the Relief of Sore Throat Pain in Patients With Acute Pharyngitis

Primary Objective:

To assess the efficacy of the new hard boiled Ambroxol lozenges 20 mg for the relief of sore throat pain in patients with acute pharyngitis.

Secondary Objective:

To assess the safety of the new hard boiled Ambroxol lozenges 20 mg in patients with acute pharyngitis.

Study Overview

• Status: Completed
• Conditions: Pharyngitis
• Intervention / Treatment: Drug: ambroxol BIH1526; Drug: placebo

Detailed Description

Duration per participant is up to 4 days.

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Africa
  • Johannesburg, South Africa
    • Investigational Site Number 7100005

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Adult male or female patients complaining of sore throat due to acute pharyngitis with an onset no more than 72 hours prior to Visit 1.
• Patients with a score of 6 or greater on a 0-10-point pain intensity numerical rating scale.
• Signed written informed consent.

Exclusion criteria:

Patients suffering from pharyngitis of bacterial origin.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ambroxol hydrochloride (BIH1526); One lozenge 20 mg on as-needed basis, up to 6 times per day	Drug: ambroxol BIH1526; Pharmaceutical form: lozenges Route of administration: oromucosal
PLACEBO_COMPARATOR: Placebo; One lozenge on as-needed basis, up to 6 times per day	Drug: placebo; Pharmaceutical form: lozenges Route of administration: oromucosal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity difference (PID)	Change from baseline to hour 3 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-3h)	hour 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SPID	Change from baseline to hour 24 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-24h)	hour 24
3-hour patient assessment of efficacy	Patient assessment of efficacy after 3 hours of the first study drug intake using a 5-point verbal rating scale (VRS) to rate whether the trial medication relieves sore throat pain, where 0 = poor and 4 = excellent	hour 3
24-hour patient assessment of efficacy	Patient assessment of efficacy after 24 hours of the first study drug intake using a 5-point VRS	hour 24
Adverse events	Incidence of the adverse events	baseline to day 4
Patient assessment of tolerability	Patient assessment of tolerability after 3 hours, Day 1, on Day 2, Day 3 and Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent	hour 3, hour 24 and day 2, day 3 or day 4
Final assessment of tolerability	Investigator and patient assessment of tolerability on Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent	day 4

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• Sousa R, Lakha DR, Brette S, Hitier S. A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis. Pulm Ther. 2019 Dec;5(2):201-211. doi: 10.1007/s41030-019-00100-w. Epub 2019 Oct 18.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2018
• Primary Completion (ACTUAL): September 2, 2018
• Study Completion (ACTUAL): September 2, 2018

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (ACTUAL): July 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

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: LPS15328; U1111-1202-9392 (OTHER: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No