Evaluation of Treatments for Sore Throat Associated With Acute Pharyngitis and/or Viral Tonsillitis

NCT07569939 | Not Yet Recruiting

• 2 other identifiers: RBHP 2026 PICKERING (PharyTol)2026-A00430-51
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Sore throats that have developed recently-within the last 3 days-are primarily caused by an infectious inflammation of the tonsils (tonsillitis) and/or the entire oropharynx (pharyngitis). They may be accompanied by a runny nose or cough as part of a nasopharyngitis. This inflammation is generally caused by infectious agents (bacterial or viral) that often appear in the fall and affect people of all ages. The majority of acute tonsillitis cases are viral and affect approximately 9 million people in France each year. Treatment for viral causes is symptomatic. The use of medical devices in the form of topical applications, such as throat sprays, which target the surface of the throat and mechanically dislodge and drain contaminants while acting as a cleansing solution, can help patients by alleviating symptoms and improving quality of life. The purpose of this study is to confirm, in a post-market setting, the tolerability of four medical devices based on real-world data. These products have already been the subject of two publications, with a third currently under review. Their tolerability has therefore already been evaluated previously. However, changes to the European Medical Device Regulation (2017/745) have led G-MED to request the conduct of this post-market study.

Conditions

Pharyngitis or Tonsillitis or Acute Nasopharyngitis or Viral Sore Throat

Outcome Measures

Primary Outcomes (1)

• Tolerance

  Collection of adverse events (AEs) during the period of use of HMG, PHN, PHR, TUR products in an electronic daily recording book

  From visit 1 (day 1) to visit 2 (day 8)

Secondary Outcomes (4)

• Efficiency

  From visit 1 (day 1) to the last day of use of the study product (day 8)

• Efficiency

  From visite 1 (day 1) to visit 2 (day 8)

• Quality of life impact

  From visite 1 (day 1) to visit 2 (day 8)

• Device defect

  From visit A (day 1) to visit 2 (day 8)

Study Arms (4)

HMG

EXPERIMENTAL

Patients included in the "HMG" arm will receive the medical device of the same name.

Device: HMG

PHN

EXPERIMENTAL

Patients included in the "PHN" arm will receive the medical device of the same name.

Device: PHN

PHR

EXPERIMENTAL

Patients included in the "PHR" arm will receive the medical device of the same name.

Device: PHR

TUR

EXPERIMENTAL

Patients included in the "TUR" arm will receive the medical device of the same name.

Device: TUR

Interventions

HMG DEVICE

Patients included in the "HMG" arm will receive the medical device of the same name.

HMG

PHR DEVICE

Patients included in the "PHR" arm will receive the medical device of the same name.

PHR

TUR DEVICE

Patients included in the "TUR" arm will receive the medical device of the same name.

TUR

PHN DEVICE

Patients included in the "PHN" arm will receive the medical device of the same name.

PHN

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• McIsaac score \< 2 or rapid diagnostic orientation tests (TROD) for group A beta-hemolytic streptococcus negative
• Effective contraception for female patients of childbearing age
• Cooperation and sufficient understanding to comply with the requirements of the trial
• Acceptance of registration in the SI-RIPH database
• Having received informed information and agreeing to give written consent
• Affiliated with the French Social Security scheme.

You may not qualify if:

• Hypersensitivity/previous allergy to any of the product components,
• Pharyngitis or tonsillitis or acute rhinopharyngitis complicated (phlegmon, acute otitis media, pneumonia…) or severely intolerable cough,
• Positive antigen test for influenza A/B or Covid-19 and infection requiring etiological treatment according to recommendations,
• Other ongoing treatments for acute pharyngitis or tonsillitis (local treatment, antibiotics, corticosteroids, antiretroviral…),
• Comorbidities or health conditions deemed incompatible with the trial by the investigator,
• Recent ENT surgery (\<6 months),
• Pulmonary pathology (COPD, asthma…),
• Immunodeficiency (according to patient's report),
• Pregnant woman or currently breastfeeding,
• Benefiting from legal protection measures (guardianship, trusteeship, deprivation of liberty, judicial protection).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Pharyngitis; Tonsillitis; Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)