Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07330856
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07330856
Study Brief:
Protocol Section:
NCT07330856