N/A
N=200
Testing the Efficacy in Adults With Cold of HEalsea Rescue*
Common Cold
Bottom Line
View on ClinicalTrials.gov: NCT05819190 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: 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) — 135.60; 177.77 Score on a scale*day — p=0.0192
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Healsea Rescue* (Device); Placebo (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lallemand Pharma AG
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
135.60; 177.77 | 0.0192 sig |
| PRIMARY 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) |
122.50; 163.21 | 0.0296 sig |
| SECONDARY AUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days |
67.11; 87.57 | 0.0085 sig |
| SECONDARY AUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days |
54.36; 74.50 | 0.0081 sig |
| SECONDARY Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose |
6.1; 7.2 | 0.0050 sig |
| SECONDARY Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose |
5.9; 6.9 | 0.0107 sig |
| SECONDARY Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing |
3.3; 4.3 | 0.0424 sig |
| SECONDARY Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat |
3.9; 3.9 | 0.430 |
| SECONDARY Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough |
4.2; 4.3 | 0.339 |
| SECONDARY Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat |
4.5; 4.3 | 0.704 |
| SECONDARY Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness |
3.7; 3.9 | 0.298 |
| SECONDARY Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion |
4.7; 3.9 | 0.906 |
| SECONDARY Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion |
3.1; 3.2 | 0.582 |
| SECONDARY Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired |
4.7; 4.4 | 0.743 |
| SECONDARY Cumulative Number of Days of Usual Medication for Common Cold Use |
7; 15 | 0.605 |
| SECONDARY Subject Satisfaction Regarding Ease of Use of the Nasal Spray |
0; 1; 4; 3; 8; 9 | 1.000 |
| SECONDARY Characterization of Residual Taste by the Subject |
4; 3; 59; 61; 21; 21 | 0.988 |
| SECONDARY Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject |
3; 5; 11; 11; 47; 37 | 0.483 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05819190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.