Evaluation of Treatments for Dry or Productive Cough

Condition(s) studied

Investigational drug(s) / intervention(s)

Group CDN: VB-ChSp-D-N® (CDN) is a film-forming liquid dressing designed for the treatment of cough. Key Features: \*Administration: - Initial Dose (Day 1): 4 sprays every 30 minutes for 2 hours, then 4 sprays every 3-4 hours for the remainder of the day. - Maintenance Dose (Days 2-7): 4 sprays every 3-4 hours (4 times daily) \*Mechanism: Forms a protective film that draws fluid from the tissues, creating an outward flow. This lifts contaminants from the throat's surface and ensures sustained hydration, thereby alleviating cough. \*Use Case: Targeted Throat Cough Relief. Additional Notes: \*Non systemic (local action). \*CE-marked as a Class I medical device (under EU Directive 93/42/EEC).

Group CW: VB-ChSp-W® (CW) is a film-forming liquid dressing designed for the treatment of cough. Key Features: \*Administration: - Initial Dose (Day 1): 4 sprays every 30 minutes for 2 hours, then 4 sprays every 3-4 hours for the remainder of the day. - Maintenance Dose (Days 2-7): 4 sprays every 3-4 hours (4 times daily) \*Mechanism: Forms a protective film that draws fluid from the tissues, creating an outward flow. This lifts contaminants from the throat's surface and ensures sustained hydration, thereby alleviating cough. \*Use Case: Targeted Throat Cough Relief Additional Notes: \*Non systemic (local action) \*CE-marked as a Class I medical device (under EU Directive 93/42/EEC).

Study summary

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.

The study is designed as a Category 4.2 clinical investigation according to applicable regulations, focusing on devices already bearing the CE mark and used within their intended purpose as per the manufacturer's instructions. The hypothesis is that both devices demonstrate an acceptable real-world tolerability profile, with a pre-defined threshold for adverse event incidence not to be exceeded, while also showing a positive impact on cough symptoms and patient quality of life.

Methodological Framework:

Design: A two-stage Fleming design will be implemented separately for each device arm to sequentially assess the primary tolerability outcome. This design allows for an early stopping rule if an unacceptable number of adverse events is observed in the first cohort of participants.

Population: The study will enroll adult patients (aged 18-65) presenting with an acute cough of less than three weeks' duration, attributed to a suspected viral etiology (e.g., common cold, viral pharyngitis). Key exclusion criteria are in place to ensure a population suitable for device evaluation, including the absence of underlying chronic respiratory conditions, bacterial infection, or use of prohibited medications that could confound results.

Intervention: Eligible participants will be randomized in a 1:1 ratio to use either the CDN spray (n ≤ 29) or the CW spray (n ≤ 29) according to the prescribed labeling for a 7-day treatment period.

Assessments: Data collection emphasizes real-world evidence capture. Participants will use an electronic daily diary throughout the treatment period to report cough symptoms (via a validated patient-reported outcome instrument), any adverse events, concomitant medications, and potential device defects (recorded as a binary yes/no occurrence). Additionally, patient-reported quality of life related to cough will be assessed using a standardized questionnaire at baseline (Day 1) and at the end of treatment (Day 8). Two on-site clinical visits (Days 1 and 8) will be conducted for clinical examination and procedures.

Outcome Measures:

The study employs a hierarchical assessment of endpoints:

Primary Outcome: Tolerability/Safety, defined by the incidence of device-related adverse events collected via the electronic diary.

Key Secondary Outcome: Clinical Efficacy, measured by the change from baseline in the Total Cough Symptom Score (TCSS).

Other Secondary Outcomes: These include the impact on cough-specific quality of life domains (sleep, daily activities, fatigue, irritability) and the incidence of device malfunctions or use errors.

The study will be conducted at a single investigational site (Clermont-Ferrand University Hospital, France).

Eligibility

Primary outcome measure(s)

• Collection of adverse events (AEs) during the use of investigational products CDN and CW recorded in an electronic daily diary. — From visit 1 (Day 1) and Visit 2 (Day 8)

Trial sites (1)

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