Testing the Efficacy in Adults With Cold of HEalsea Rescue*

Not Applicable

Completed

Conditions: Common Cold

Interventions: Device: Placebo
Device: Healsea Rescue*

Registration Number: NCT05819190

Lead Sponsor: Lallemand Pharma AG

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.
Healsea Rescue* group	Healsea Rescue*	Subjects will receive Healsea Rescue\* according to its intended use.

Primary Outcome Measures

Name	Time	Method
AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Full Analysis Set (FAS)	Treatment period, from Day 1 to Day 8	The WURSS-21 questionnaire scores the severity and functional impact of a cold (items 2 to 11 and 12 to 20 respectively) plus 2 items for global severity and global change (items 1 and 21 respectively). Each item is scored from 0 (not sick / Do not have this symptom / Not at all / Very much better) to 7 (severely, severe, severely, very much worse) for global assessment, symptoms, functional impairment and global change respectively. The question 21 is not included in the calculation of the total score of the WURSS-21. The minimum WURSS-21 score is zero (0) and the maximum WURSS-21 score is one hundred forty (140). The questionnaire was completed in a diary 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 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.
AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) During First 8 Days of Symptoms as Compared Between Both Groups - Per Protocol Set (PP)	Treatment period, from Day 1 to Day 8	The WURSS-21 questionnaire scores the severity and functional impact of a cold (items 2 to 11 and 12 to 20 respectively) plus 2 items for global severity and global change (items 1 and 21 respectively). Each item is scored from 0 (not sick / Do not have this symptom / Not at all / Very much better) to 7 (severely, severe, severely, very much worse) for global assessment, symptoms, functional impairment and global change respectively. The question 21 is not included in the calulation of the total score of the WURSS-21. The minimum WURSS-21 score is zero (0) and the maximum WURSS-21 score is one hundred forty (140). The questionnaire was completed in a diary 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 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.

Secondary Outcome Measures

Name	Time	Method
AUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days	Treatment period, from Day 1 to Day 8	The Symptoms' WURSS-21 questionnaire scores the severity of the cold (items 2 to 11). Each item is scored from 0 (Do not have this symptom) to 7 (Severe). The minimum Symptoms' WURSS-21 score is zero (0) and the maximum is seventy (70). The questionnaire was completed in a diary 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 Symptoms' WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days.
AUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days	Treatment period, from Day 1 to Day 8	The Quality-of-Life' WURSS-21 questionnaire scores the impact of the cold on quality of life (items 12 to 20). Each item is scored from 0 (Not at all) to 7 (Severely). The minimum Quality-of-Life' WURSS-21 score is zero (0) and the maximum is sixty three (63). The questionnaire was completed in a diary 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 Symptoms' WURSS-21 was completed during the visit. After Day 8, it was assessed once daily until the subject feels not sick for two consecutive days
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose	Through study completion, up to Day 15	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.
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose	Through study completion, up to Day 15	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.
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing	Through study completion, up to Day 15	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.
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat	Through study completion, up to Day 15	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.
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough	Through study completion, up to Day 15	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.
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat	Through study completion, up to Day 15	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.
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness	Through study completion, up to Day 15	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.
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion	Through study completion, up to Day 15	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.
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion	Through study completion, up to Day 15	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.
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired	Through study completion, up to Day 15	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.
Cumulative Number of Days of Usual Medication for Common Cold Use	Through study completion, up to Day 15	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.
Subject Satisfaction Regarding Ease of Use of the Nasal Spray	Between Day 13 and Day 15	At end of study visit (V2) subject satisfaction regarding ease of use will be recorded using a 4-points categorical scale (How would you characterize the use of Healsea® Rescue\* nasal spray? 0: not easy ; 1: pretty easy ; 2: easy ; 3: very easy).
Characterization of Residual Taste by the Subject	Between Day 13 and Day 15	At end of study visit (V2) the residual taste after using the spray will be assessed by the subject using a 4-points categorical scale (How would you characterize the residual taste after spraying Healsea® Rescue\*?0: not pleasant ; 1: neutral ; 2: pleasant ; 3: very pleasant).
Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject	Between Day 13 and Day 15	At end of study visit (V2) cleansing and moistening of nasal mucosa will be assessed by the subject using a 4-points categorical scale (How would you characterize the cleansing and moistening of nasal mucosa with Healsea® Rescue\*?0: no improvement ; 1: slight improvement ; 2: moderate improvement; 3: very clear improvement).