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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Clermont-ferrand
  Clermont-Ferrand, France Recruiting

Study contacts

• Study coordinator: Lise Laclautre
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: +33473754963

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remifentanil With or Without Lidocaine for Extubation After Thyroid Surgery

  This study tests whether adding intravenous lidocaine to remifentanil during awakening reduces coughing after thyroidectomy extubation in adults.

  Recruiting Phase 4 Pamukkale University · Denizli · NCT07857356

• Oliceridine vs Sufentanil for cough during anesthesia induction

  This trial tests whether oliceridine is better than sufentanil at reducing cough during anesthesia induction in adults undergoing elective surgery.

  Recruiting Phase 4 Shanghai Pulmonary Hospital, Shanghai, China · Tianmen, Hubei · NCT07660380

• Combined acupressure to reduce post-thoracotomy pain and improve lung volume

  This trial will try combined acupressure on patients after thoracotomy to see if it reduces postoperative pain and helps restore lung volume.

  Recruiting Dogus Universitesi · Istanbul · NCT07411417

• Rengalin liquid for dry cough in children aged 6 months to 3 years

  This will test whether Rengalin liquid reduces dry cough in children 6 months to 3 years old with acute viral upper respiratory infections.

  Recruiting at 22 sites Phase 3 Materia Medica Holding · Gatchina and 29 other locations · NCT07171099

• Mechanism-guided treatment versus proton-pump inhibitor therapy for chronic throat symptoms

  This trial will test whether a mechanism-guided approach combining personalized acid-suppression and voice therapy helps adults (18–89) with chronic throat symptoms more than usual proton pump inhibitor (PPI) treatment.

  Recruiting Phase 4 University of California, San Diego · San Deigo, California · NCT06999577

• Cough control with dexmedetomidine, magnesium sulfate, or lidocaine after general anesthesia

  This study will see if dexmedetomidine, magnesium sulfate, or lidocaine reduces how often and how hard adults cough while waking from general anesthesia.

  Recruiting Phase 3 Al-Azhar University · Asyut · NCT06979141

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.