Recruiting PHASE4 Cough

New treatment option for Cough

Official title Evaluation of Treatments for Dry or Productive Cough

ClinicalTrials.gov ID: NCT07330856

What this study is testing

What is Group CDN?

Group CDN is an investigational medicine, given as an once-daily, being studied as a potential treatment for cough.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This is a post-marketing, monocentric, open-label, randomized, two-arm, parallel-group clinical study. Its primary objective is to evaluate the real-world tolerability and safety profile of two CE-marked Class I medical devices formulated as throat sprays: VB-ChSp-D-N (CDN) and VB-ChSp-W (CW), when used for symptomatic relief of cough associated with suspected viral upper respiratory infections.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join if

  • 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...
  • For patients with suspected pharyngitis/tonsillitis: McIsaac score \< 2 or a negative rapid antigen detection test for Group A beta-hemolytic...
  • Effective contraception for female patients of childbearing potential,

You likely can't join if

  • 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),
See the full eligibility criteria
Who can join
  • 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...
  • 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
What rules you out
  • 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...
  • 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).

The study team makes the final eligibility decision.

Where it's taking place

  • Clermont-Ferrand, France

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Clermont-Ferrand, France. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.