Two CE‑marked throat sprays for adults with a recent dry or productive cough

Evaluation of Treatments for Recent Dry or Productive Cough Accompanying Benign Viral Rhinopharyngeal Infectious Episodes.

This study will try two CE‑marked throat sprays to see if adults with a recent viral cough tolerate them well and get symptom relief.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University Hospital, Clermont-Ferrand (Academic / other)
• Locations: 1 site (Clermont-Ferrand)
• Trial ID: NCT07330856 on ClinicalTrials.gov

What this trial studies

This is a post‑marketing, monocentric, open‑label, randomized, two‑arm, parallel‑group Phase 4 study conducted at CHU de Clermont‑Ferrand. It compares two CE‑marked Class I throat spray devices (VB‑ChSp‑D‑N and VB‑ChSp‑W) used according to the manufacturer's instructions. Each device arm is evaluated separately using a two‑stage Fleming design with predefined thresholds for adverse event incidence, and secondary measures include cough symptoms and patient quality of life. The trial enrolls adults with an acute dry or productive cough of less than three weeks suspected to be due to a viral upper respiratory infection.

Who should consider this trial

Good fit: Adults 18–65 years old with an acute dry or productive cough under three weeks from suspected viral upper respiratory infection (with McIsaac <2 or a negative rapid strep test for suspected pharyngitis), able to consent, and covered by French national health insurance are ideal candidates.

Not a fit: Patients with known hypersensitivity to any spray components, chronic cough (>3 weeks), confirmed bacterial throat infection, those outside the 18–65 age range, or unable to comply with study procedures are unlikely to benefit.

Why it matters

Potential benefit: If successful, these sprays may offer a well‑tolerated, readily available option to ease cough symptoms and improve short‑term quality of life.

How similar studies have performed: Some over‑the‑counter throat sprays and demulcents have shown symptomatic benefit in real‑world settings, but randomized controlled evidence specific to these CE‑marked devices is limited.

Eligibility criteria

Inclusion Criteria:

* Male or female,
* Aged 18 to 65 years,
* Presenting with an acute dry or productive cough for less than 3 weeks, associated with one of the following viral conditions: Acute viral rhinitis, Acute viral rhinopharyngitis, Acute viral tonsillitis, Acute viral pharyngitis / tonsillitis,
* For patients with suspected pharyngitis/tonsillitis: McIsaac score \< 2 or a negative rapid antigen detection test for Group A beta-hemolytic Streptococcus,
* Effective contraception for female patients of childbearing potential,
* Sufficient cooperation and understanding to comply with the requirements of the trial,
* Acceptance of registration in the SI-RIPH database (Système d'Information pour la Recherche sur les Produits de Santé),
* Having received clear information and agreeing to provide written informed consent,
* Covered by the French national health insurance system

Exclusion Criteria:

* Hypersensitivity or history of allergy to any component of the investigational products,
* Severe, poorly tolerated cough,
* Complicated acute rhinitis (e.g., acute bacterial sinusitis, acute otitis media, acute bronchitis, or pneumonia),
* Chronic or allergic rhinosinusitis,
* Bacterial tonsillitis or pharyngitis,
* Positive antigen test for influenza A/B or COVID-19 requiring etiological treatment per current guidelines (Appendix 5),
* Concurrent use of antitussives, bronchodilators, inhaled corticosteroids, other pulmonary-targeted therapies, or medications known to induce cough (such as ACE inhibitors, ARBs, etc.), antibiotics, antivirals, or any other treatment deemed incompatible with the study by the investigator,
* Recent ENT surgery (\<6 months),
* Pulmonary disease (e.g., COPD, asthma),
* Immunodeficiency (based on patient declaration),
* Comorbidities or a health status judged incompatible with the trial by the investigator (e.g., Gastroesophageal Reflux Disease \[GERD\] or abnormal lung auscultation),
* Pregnant or breastfeeding women,
* Regular tobacco smoker (as judged by the investigator),
* Current participation in another clinical trial, being in an exclusion period from a previous trial, or having received total compensation exceeding 6000 euros in the 12 months prior to study start,
* Under legal protection measures (guardianship, trusteeship, deprivation of liberty, judicial safeguard).

Where this trial is running

Clermont-Ferrand

• CHU de Clermont-ferrand — Clermont-Ferrand, France (Recruiting)

Study contacts

• Study coordinator: Lise Laclautre

Conditions Cough