A Phase 4 interventional study of Group CDN and Group CW in Cough, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University Hospital, Clermont-Ferrand · Phase 4, Interventional, and Other
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).
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 58 is below the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
VB-ChSp-D-N® (CDN) is a film-forming liquid dressing designed for the treatment of cough.
Combination Product: Group CDN
VB-ChSp-W® (CW) is a film-forming liquid dressing designed for the treatment of cough.
Combination Product: Group CW
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).
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).
Collection of adverse events (AEs) during the use of investigational products CDN and CW recorded in an electronic daily diary.
Time frame: From visit 1 (Day 1) and Visit 2 (Day 8)
Total Cough Symptom Score
Clinical improvement (yes/no), defined as a reduction of at least 30% in the Total Cough Symptom Score from its baseline value to the average of scores measured during the last 3 days of product use (Days 5, 6, and 7). Details of Total Cough Symptom Score (TCSS) is composed of 9 items (ranging from 0 to 90): * Frequency of cough * Severity of cough * Coughing fits / Paroxysmal cough * Chest or abdominal pain due to coughing * Hoarse voice due to coughing * Shortness of breath due to coughing * Sore throat sensation * Interruption of conversations (in person or on the phone) due to coughing * Difficulty falling asleep due to coughing
Time frame: At Visit 1 and from day 5 to day 7
Sleep measurement
Change in quality of sleep measured before (Day 1) and after (Day 8). Participants will indicate their level of discomfort on a Visual Analog Scale ranging from 0 ("not at all bothersome/impacted") to 10 ("extremely bothersome/severely impacted").
Time frame: From Visit 1 (Day 1) to Visit 2 (Day 8)
Daily activities measurement
Change in daily activities measured before (Day 1) and after (Day 8). Participants will indicate their level of discomfort on a Visual Analog Scale ranging from 0 ("not at all bothersome/impacted") to 10 ("extremely bothersome/severely impacted").
Time frame: [Time Frame: From Visit 1 (Day 1) to Visit 2 (Day 8)]
Fatigue measurement
Change in fatigue measurement measured before (Day 1) and after (Day 8) product use. Participants will indicate their level of discomfort on a Visual Analog Scale ranging from 0 ("not at all bothersome/impacted") to 10 ("extremely bothersome/severely impacted").
Time frame: [Time Frame: From Visit 1 (Day 1) to Visit 2 (Day 8)]
Irritability measurement
Change in irritability measurement measured before (Day 1) and after (Day 8) product use. Participants will indicate their level of discomfort on a Visual Analog Scale ranging from 0 ("not at all bothersome/impacted") to 10 ("extremely bothersome/severely impacted").
Time frame: [Time Frame: From Visit 1 (Day 1) to Visit 2 (Day 8)]
Collection of defects in products
Device defects were monitored through a binary (yes/no) reporting system in an electronic daily diary.
Time frame: From Visit 1 (Day 1) to Visit 2 (Day 8)
Started Jan 2026 (actual). Primary completion is estimated for Mar 2027, 14 months after the start.
Of 20 phase 4 interventional studies under Cough, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 33. This study's planned 14 months is close to that.
How these figures are worked out, and which studies are left out of them.
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