CoughPhase 4SPRATONCT07330856
Evaluation of Treatments for Dry or Productive Cough
A Phase 4 study testing Group CDN and Group CW in people with Cough, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cough
- What is being tested?
- Group CDN and Group CW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2026to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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,
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- 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
Who cannot join
- 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),
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gisèle Pickering contact
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Gisèle Pickering
About this study
Official title: Evaluation of Treatments for Recent Dry or Productive Cough Accompanying Benign Viral Rhinopharyngeal Infectious Episodes.
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.
Read more
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).
- Conditions
- Cough
- Being tested
- Group CDN, Group CW
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CDNCombination product
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 CWCombination product
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 group | Role | What they receive |
|---|---|---|
| Group CDN | Experimental | VB-ChSp-D-N® (CDN) is a film-forming liquid dressing designed for the treatment of cough. Receives: Combination Product: Group CDN |
| Group CW | Experimental | VB-ChSp-W® (CW) is a film-forming liquid dressing designed for the treatment of cough. Receives: Combination Product: Group CW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of adverse events (AEs) during the use of investigational products CDN and CW recorded in an electronic daily diary.
Measured: From visit 1 (Day 1) and Visit 2 (Day 8)
Secondary outcomes (6)
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
Measured: 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").
Measured: 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").
Measured: [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").
Measured: [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").
Measured: [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.
Measured: From Visit 1 (Day 1) to Visit 2 (Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start19 Jan 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330856
- Sponsor's protocol ID
- RBHP 2025 PICKERING 2
- Other IDs
- 2025-A02027-42
- Acronym
- SPRATO
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatments for Recent Dry or Productive Cough Accompanying Benign Viral Rhinopharyngeal Infectious Episodes.
- ClinicalTrials.gov ID
- NCT07330856
- Acronym / sponsor ID
- SPRATO / RBHP 2025 PICKERING 2
- Conditions
- Cough
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CDN | Experimental | Combination Product: Group CDNVB-ChSp-D-N® (CDN) is a film-forming liquid dressing designed for the treatment of cough. |
| Group CW | Experimental | Combination Product: Group CWVB-ChSp-W® (CW) is a film-forming liquid dressing designed for the treatment of cough. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group CDNVB-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). | Combination product | Group CDN |
| Group CWVB-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). | Combination product | Group CW |
Primary outcome
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)
6 secondary outcomes
Total Cough Symptom Score
Time frame: At Visit 1 and from day 5 to day 7
Sleep measurement
Time frame: From Visit 1 (Day 1) to Visit 2 (Day 8)
Daily activities measurement
Time frame: [Time Frame: From Visit 1 (Day 1) to Visit 2 (Day 8)]
Fatigue measurement
Time frame: [Time Frame: From Visit 1 (Day 1) to Visit 2 (Day 8)]
Irritability measurement
Time frame: [Time Frame: From Visit 1 (Day 1) to Visit 2 (Day 8)]
Collection of defects in products
Time frame: From Visit 1 (Day 1) to Visit 2 (Day 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gisèle Pickering contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group CDN and Group CW in people with Cough, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.