Testing the Efficacy in Adults With Cold of HEalsea Rescue* (NCT05819190) | Clinical Trial Compass
CompletedNot Applicable
Testing the Efficacy in Adults With Cold of HEalsea Rescue*
Bulgaria200 participantsStarted 2022-12-14
Plain-language 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 Symbiofilmâ„¢ act in a synergistic manner to alleviate symptoms of the acute rhinitis phase resulting in better efficacy than isotonic saline solution without Symbiofilmâ„¢ used as Placebo in adults with early symptoms of common cold / acute infectious rhinitis.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
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)
Timeframe: Treatment period, from Day 1 to Day 8
2
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)