Testing the Efficacy in Adults With Cold of HEalsea Rescue*

Study Overview
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Brief Summary
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Healsea® Rescue* is a CE-marked class I medical device. This is a saline-based nasal spray supplemented with a natural Symbiofilm™ extract (0.04%) isolated from the marine bacteria. Healsea® Rescue* is indicated in adults for the treatment of symptoms of acute respiratory tract infections, rhinitis or rhinosinusitis, and for reduction of the swelling of the nasal mucosa. The goal of this clinical trial is to demonstrate that hypertonic saline solution and Symbiofilm™ act in a synergistic manner to alleviate symptoms of the acute rhinitis phase resulting in better efficacy than isotonic saline solution without Symbiofilm™ used as Placebo in adults with early symptoms of common cold / acute infectious rhinitis.

Detailed Description
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Upper respiratory tract infections (URTIs) and sino-nasal symptoms are very frequent, especially during the fall and the winter. The common cold is caused by a variety of viruses such as human rhinoviruses and influenza viruses. The incidence of acute rhinitis/rhinosinusitis is very high, estimated to occur from 2 to 5 times per year in the average adult. However, the natural course of acute rhinitis in adults is favorable since 75% of persons have a reduction or resolution of symptoms within 7 days. Only 0.5 to 2.0% of subjects develop secondary bacterial sinusitis requiring antibiotic prescription. Bacterial over infections and progression to a chronic state are favoured by the formation of biofilms, which facilitate bacterial growth and persistence as well as reducing antibiotic efficacy. The socioeconomic impact of acute rhinitis is well established: visits to GP, additional prescriptions and over prescription of antibiotics, workdays lost. Although clinical evidence from well-designed trials is scarce, European and American guidelines for acute rhinosinusitis recommend daily nasal saline irrigation for reduction of the severity of symptoms and for speeding recovery. The exact mechanisms by which nasal irrigation works are not known. However, most of the experts agree that it is primarily a mechanical intervention leading to direct cleansing of the nasal mucosa. Hypertonic saline solutions are generally considered as more effective than isotonic saline solutions in reducing nasal symptoms in the acute phase. Nevertheless, the efficacy of such solution remains moderate. Healsea® Rescue* is a CE-marked class I medical device. This is a saline-based nasal spray supplemented with a natural Symbiofilm™ extract (0.04%) isolated from the marine bacteria Bacillus licheniformis T14. The nasal solution is hypertonic (NaCl 2.7%). Symbiofilm™ is an exopolysaccharide with emulsifying properties and in vitro antibiofilm activity and detachment properties against various bacterial pathogens. Symbiofilm™ also protects in vitro human nasal epithelial cells viability after Rhinovirus, Adenovirus, Coronavirus OC43 and Flu infection. The aim of this study is to demonstrate that hypertonic saline solution and Symbiofilm™ act in a synergistic manner to alleviate symptoms of the acute rhinitis phase resulting in better efficacy than isotonic saline solution without Symbiofilm™ used as Placebo. The study comprises two parts: - Part 1 (Day1-Day 8): treatment of the acute phase • with Healsea® Rescue*, 2 puffs in each nostril 2 times per day during 7 days (14 intakes of the investigational device). or • with isotonic nasal spray (Placebo), 2 puffs in each nostril 2 times per day during 7 days (14 intakes of the Placebo). - Part 2 (Day 9-Day 13/15): follow-up phase. The study comprises two visits and one telephone call: Visit 1 (V1) at Day 1 Telephone call at Day 8 End of study visit (Visit 2, V2) between Day 13 and Day 15.

Official Title
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Efficacy and Safety of Healsea® Hypertonic Nasal Spray 2.7% in the Treatment of Acute Infectious Rhinitis in Adults

Conditions
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Common Cold

Intervention / Treatment
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* Device: Healsea Rescue*
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/Female subjects >18 years Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry Symptoms of headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, sneezing with a score ≤9 (according to a self-rated symptom score; scale: 0 → 3 [0: no symptom to 3: severe intensity]) At least one of these symptoms: sore throat, runny nose or blocked nose (i.e., with a score ≥1) Willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the information consent form Patient with a smartphone and an internet connection. Exclusion Criteria: Known hypersensitivity/allergy to any component of the test device Medical history or any current disease that is considered by the investigator as a reason for non-inclusion Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores Antibiotic intake within 2 weeks before screening Systemic or local corticosteroids (nasal route or inhalation) within 4 weeks before screening Antihistamines intake for allergy when treatment was started from less than 4 weeks Chronic decongestant use Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom score at screening (NSAID, nasal decongestants, cough medicines) Pregnant/Lactating female or absence of efficient contraception

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healsea Rescue* group<br>Subjects will receive Healsea Rescue* according to its intended use. | Device: Healsea Rescue*<br>* Subjects will be administered with Healsea Rescue* by spraying 2 puffs in each nostril 2 times per day during 7 days.<br>|
| Placebo Comparator: Placebo group<br>Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue. | Device: Placebo<br>* Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue* by spraying 2 puffs in each nostril 2 times per day during 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) during first 8 days of symptoms will be compared between both groups | The WURSS-21 will be assessed once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day1, the WURSS-21 will be completed during the visit. After Day 8, the WURSS-21 will be assessed once daily until the subject feels not sick for two consecutive days. | Treatment period, from Day 1 to Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of the symptoms sub-score (items 2-11) of the WURSS-21 during first 8 days | The WURSS-21 will be assessed once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the WURSS-21 will be completed during the visit. After Day 8, the WURSS-21 will be assessed once daily until the subject feels not sick for two consecutive days. | Treatment period, from Day 1 to Day 8 | 
| AUC of the Quality of Life sub-score (items 12-20) of the WURSS-21 during first 8 days | The WURSS-21 will be assessed once daily in the evening, taking into account the symptoms from the morning to the evening, during Day 2-Day 8 (day of the end of treatment). At Day 1, the WURSS-21 will be completed during the visit. After Day 8, the WURSS-21 will be assessed once daily until the subject feels not sick for two consecutive days. | Treatment period, from Day 1 to Day 8 | 
| Duration of cold symptoms assessed by means of the WURSS-21 | For each item, the duration is defined as the number of symptomatic days between Visit 1 and the first day the subject reports not to have this symptom for two consecutive days. | Through study completion, up to Day 15 | 
| Frequency and number of days of concomitant treatments use that may affect common cold symptoms | Concomitant treatments (antipyretics, systemic or local mucolytics, decongestants, antitussives, antibiotics) use will be reported in the e-diary by the patient throughout the study, validated by the investigator at the end of study visit before being reported in the e-CRF. | Through study completion, up to Day 15 | 
| Subject satisfaction regarding ease of use, efficacy, local tolerance and tasteglobal and subject feedback on treatment use | At end of study visit (V2) subject satisfaction regarding ease of use, efficacy, local tolerance and taste will be recorded using a 4-points categorical scale. The global subject feedback on treatment use will be assessed through the question: Will you recommend the prescribed treatment for treatment / prevention of acute rhinitis?. | Between Day 13 and Day 15 | 
| Reporting of adverse events and incidents | Assessment of adverse events and incidents throughout the study | Through study completion, up to Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute infectious rhinitis, Rhinosinusitis, Respiratory tract infection, Nasal irrigation