Medical devices · Private label
CoughSpray ProtectAcute dry
and productive cough
Dry or productive cough: soothe the throat, protect its surface and help remove mucus with one sugar-free spray. CoughSpray Protect is intended for the treatment of acute cough in adults and children aged 8 and over. Its local physical action helps reduce cough frequency and intensity while relieving associated throat pain, irritation and chest discomfort.
Supplied as a 30 mloral spray, this medical device is applied directly to the throat. It combines Vitrobio's film-forming glycerol technology with simple spray application. Made in France, it is available to partners seeking a dry and productive cough product under their own brand.
Your cough care product,
under your brand
Clinical study
Randomised, double-blind study in acute productive cough; 54 patients completed the study.
Population
Adults and children aged 8 and over.
Indication
Treatment of acute dry and productive cough.
Benefits
for patients
- Immediate action (osmotic mechanical action).
- Relieves acute dry and productive cough.
- Reduces cough frequency and intensity.
- Soothes cough-related throat pain and irritation.
- Helps thin and remove mucus in the throat.
- Sugar-free.
- 100% plant-derived ingredients.
Mode of action
CoughSpray Protect deposits a film on the throat mucosa. Two complementary mechanical functions act simultaneously to improve local comfort and promote the natural removal of secretions:
- Protecting and soothing the throat. The film covers the mucosa, limits contact with irritants and helps reduce the discomfort that drives the urge to cough. It also helps limit mucus accumulation on the surface.
- Hydrating and helping remove mucus. Osmotic action attracts fluids towards the mucus layer. It helps thin and remove mucus in the throat while maintaining a hydrated environment that soothes dryness and irritation.
Osmotic mechanical action starts on application. The film acts locally in the pharyngeal area and preserves the protective cough reflex.
Clinical study · Acute productive cough
Clinical study
Reduced throat pain from day 2 and cough intensity from day 3. A randomised, double-blind study compared the CW formula with a physiological saline spray for 15 days in patients with recent-onset acute productive cough. The protocol included patients aged 8 to 65. Of 58 randomised patients, 54 completed the study, including 39 on CW and 15 on physiological saline.
| Benefit assessed | Result with CoughSpray Protect | Comparison context |
|---|---|---|
| Throat pain on day 2 | 40% decrease in mean score | Compared with baseline; p ≤ 0.002 |
| Cough intensity on day 3 | 36% decrease in mean score | Compared with baseline; p ≤ 0.002. Score also lower than in the physiological saline group; p < 0.05 |
| No coughing episodes on day 15 | 79.5% of patients, or 31 out of 39 | Versus 20.0%, or 3 out of 15, with physiological saline |
Symptoms were rated on scales from 0 to 10. A lower score indicates improvement; a frequency score of zero means no reported coughing episodes. P-values refer to the comparisons specified in the table. No specific p-value is reported for the proportions of patients without coughing episodes on day 15.
Good tolerability observed in this study.
The detailed clinical dossier is available on request under a non-disclosure agreement.
Manufacturing & quality
Certified French manufacturing
CoughSpray Protect is manufactured in France at the Vitrobio laboratory. Its Origine France Garantie certification is issued by Bureau Veritas.
ISO 13485
Quality management system certified by GMED.
Product details
| Field | Value |
|---|---|
| Code | CW |
| Public name | CoughSpray Protect |
| Product type | Medical device |
| Regulatory class | Class IIa |
| Regulatory framework | Regulation (EU) 2017/745 on medical devices |
| Notified body | GMED |
| Population / age | Adults and children aged 8 and over |
| Category | Cough |
| Full official indication | Treatment of acute productive and dry cough in adults and children aged 8 and over |
| Composition | Film-forming glycerol, CW-cyanidin |
| Format / volume | 30 ml oral spray |
| Shelf life before opening | 3 years |
| Storage conditions | Below 25 °C, protected from moisture |
| Shelf life after opening | 1 month |
| Legal manufacturer | Vitrobio SAS |
| Country of manufacture | France, manufactured in-house |
| Quality system | Quality management system certified to ISO 13485 by GMED |
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