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CompletedNCT05819190TEACHERUpdated Oct 8, 2024Results posted

Testing the Efficacy in Adults With Cold of HEalsea Rescue*

An interventional study of Healsea Rescue* and Placebo in Common Cold, sponsored by Lallemand Pharma AG. Completed at 1 site in Bulgaria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Lallemand Pharma AG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Common Cold

Keywords

  • Acute infectious rhinitis
  • Rhinosinusitis
  • Respiratory tract infection
  • Nasal irrigation
03

In context

Common Cold

219 studies on the registry are indexed under Common Cold; 23 are open to participants now.

This study's enrollment of 200 is above the median of 150 across 184 interventional studies indexed under Common Cold.

Browse Common Cold studies →

Lead sponsor

Lallemand Pharma AG is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male/Female subjects >18 years
  2. Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
  3. 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])
  4. At least one of these symptoms: sore throat, runny nose or blocked nose (i.e., with a score ≥1)
  5. Willingness to participate as evidenced by voluntary written and has received a signed and dated copy of the information consent form
  6. Patient with a smartphone and an internet connection.

Exclusion criteria

Exclusion Criteria:

  1. Known /allergy to any component of the test device
  2. Medical history or any current disease that is considered by the investigator as a reason for non-inclusion
  3. Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps
  4. History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
  5. Antibiotic intake within 2 weeks before screening
  6. Systemic or local (nasal route or inhalation) within 4 weeks before screening
  7. Antihistamines intake for allergy when treatment was started from less than 4 weeks
  8. Chronic decongestant use
  9. 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)
  10. Pregnant/Lactating female or absence of efficient
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Healsea Rescue* group

    Subjects will receive Healsea Rescue\* according to its intended use.

    Device: Healsea Rescue*

  • Placebo comparator
    Placebo group

    Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue.

    Device: Placebo

Interventions

  • DeviceHealsea Rescue*

    Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.

  • DevicePlacebo

    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.

06

What researchers measure

Primary outcomes

  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)

    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.

    Time frame: 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)

    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.

    Time frame: Treatment period, from Day 1 to Day 8

Secondary outcomes

  1. AUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days

    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.

    Time frame: Treatment period, from Day 1 to Day 8

  2. AUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days

    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

    Time frame: Treatment period, from Day 1 to Day 8

  3. Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose

    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.

    Time frame: Through study completion, up to Day 15

  4. Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose

    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.

    Time frame: Through study completion, up to Day 15

  5. Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing

    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.

    Time frame: Through study completion, up to Day 15

  6. Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat

    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.

    Time frame: Through study completion, up to Day 15

  7. Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough

    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.

    Time frame: Through study completion, up to Day 15

  8. Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat

    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.

    Time frame: Through study completion, up to Day 15

  9. Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness

    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.

    Time frame: Through study completion, up to Day 15

  10. Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion

    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.

    Time frame: Through study completion, up to Day 15

  11. Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion

    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.

    Time frame: Through study completion, up to Day 15

  12. Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired

    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.

    Time frame: Through study completion, up to Day 15

  13. Cumulative Number of Days of Usual Medication for Common Cold Use

    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.

    Time frame: Through study completion, up to Day 15

  14. Subject Satisfaction Regarding Ease of Use of the Nasal Spray

    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).

    Time frame: Between Day 13 and Day 15

  15. Characterization of Residual Taste by the Subject

    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).

    Time frame: Between Day 13 and Day 15

  16. Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject

    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).

    Time frame: Between Day 13 and Day 15

07

Results

Posted Oct 8, 2024
Limitations and caveats
There are two limitations of this investigation. * The symptoms of common cold are known only by subjects. The WURSS-21, a subjective tool for measuring patient reported outcome, was chosen as the most relevant primary endpoint due to lack of easily measurable objective outcome. * Most subjects had a mild cold with rapid resolution and no complication; it was virtually impossible to assess the impact of using Healsea Rescue\* on the intake of acute infectious rhinitis conventional medication.

Participant flow

First patient first visit: 14th December 2022 Last patient last visit: 31 th January 2023 Location: Bulgaria, 1 site

Participant flow — Overall Study
MilestoneHealsea Rescue* GroupPlacebo Group
Started100100
Completed100100
Not completed00

Outcome measures

PrimaryAUC (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)

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.

Time frame:
Treatment period, from Day 1 to Day 8
Reported as:
Mean · Score on a scale*day
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)
Score on a scale*dayHealsea Rescue* GroupPlacebo Group
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 ± 89.88177.77 ± 125.40
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.0192
PrimaryAUC (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)

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.

Time frame:
Treatment period, from Day 1 to Day 8
Reported as:
Mean · score on a scale*day
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)
score on a scale*dayHealsea Rescue* GroupPlacebo Group
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 ± 83.42163.21 ± 114.00
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.0296
SecondaryAUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days

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.

Time frame:
Treatment period, from Day 1 to Day 8
Reported as:
Mean · score on a sub-scale*day
AUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days
score on a sub-scale*dayHealsea Rescue* GroupPlacebo Group
AUC of the Symptoms Sub-score (Items 2-11) of the WURSS-21 During First 8 Days67.11 ± 43.0987.57 ± 53.15
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.0085
SecondaryAUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days

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

Time frame:
Treatment period, from Day 1 to Day 8
Reported as:
Mean · score on a sub-scale*day
AUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days
score on a sub-scale*dayHealsea Rescue* GroupPlacebo Group
AUC of the Quality of Life Sub-score (Items 12-20) of the WURSS-21 During First 8 Days54.36 ± 59.4974.50 ± 79.15
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.0081
SecondaryDuration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose

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.

Time frame:
Through study completion, up to Day 15
Reported as:
Mean · days
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose
daysHealsea Rescue* GroupPlacebo Group
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Runny Nose6.1 ± 3.17.2 ± 3.1
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.0050
SecondaryDuration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose

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.

Time frame:
Through study completion, up to Day 15
Reported as:
Mean · days
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose
daysHealsea Rescue* GroupPlacebo Group
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Plugged Nose5.9 ± 3.16.9 ± 3.2
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.0107
SecondaryDuration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing

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.

Time frame:
Through study completion, up to Day 15
Reported as:
Mean · days
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing
daysHealsea Rescue* GroupPlacebo Group
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sneezing3.3 ± 3.44.3 ± 3.6
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.0424
SecondaryDuration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat

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.

Time frame:
Through study completion, up to Day 15
Reported as:
Mean · days
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat
daysHealsea Rescue* GroupPlacebo Group
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Sore Throat3.9 ± 3.73.9 ± 3.7
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.430 (one sided test)
SecondaryDuration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough

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.

Time frame:
Through study completion, up to Day 15
Reported as:
Mean · days
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough
daysHealsea Rescue* GroupPlacebo Group
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Cough4.2 ± 4.34.3 ± 3.9
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.339one sided test
SecondaryDuration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat

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.

Time frame:
Through study completion, up to Day 15
Reported as:
Mean · days
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat
daysHealsea Rescue* GroupPlacebo Group
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Scratchy Throat4.5 ± 3.94.3 ± 3.8
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.704one sided test
SecondaryDuration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness

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.

Time frame:
Through study completion, up to Day 15
Reported as:
Mean · days
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness
daysHealsea Rescue* GroupPlacebo Group
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Hoarseness3.7 ± 3.93.9 ± 3.9
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.298One sided test
SecondaryDuration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion

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.

Time frame:
Through study completion, up to Day 15
Reported as:
Mean · days
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion
daysHealsea Rescue* GroupPlacebo Group
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Head Congestion4.7 ± 4.23.9 ± 3.8
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.906one sided test
SecondaryDuration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion

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.

Time frame:
Through study completion, up to Day 15
Reported as:
Mean · days
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion
daysHealsea Rescue* GroupPlacebo Group
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Chest Congestion3.1 ± 3.83.2 ± 4.0
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.582one sided test
SecondaryDuration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired

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.

Time frame:
Through study completion, up to Day 15
Reported as:
Mean · days
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired
daysHealsea Rescue* GroupPlacebo Group
Duration of Cold Symptoms Assessed by Means of the WURSS-21: Duration of Feeling Tired4.7 ± 3.94.4 ± 3.8
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Wilcoxon (Mann-Whitney) · p = 0.743one sided test
SecondaryCumulative Number of Days of Usual Medication for Common Cold Use

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.

Time frame:
Through study completion, up to Day 15
Reported as:
Number · days
Cumulative Number of Days of Usual Medication for Common Cold Use
daysHealsea Rescue* GroupPlacebo Group
Cumulative Number of Days of Usual Medication for Common Cold Use715
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Fisher Exact · p = 0.605One sided test
SecondarySubject Satisfaction Regarding Ease of Use of the Nasal Spray

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).

Time frame:
Between Day 13 and Day 15
Reported as:
Count of participants · Participants
Subject Satisfaction Regarding Ease of Use of the Nasal Spray
ParticipantsHealsea Rescue* GroupPlacebo Group
use not easy01
use pretty easy43
use easy89
use very easy8887
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Fisher Exact · p = 1.000one sided test
SecondaryCharacterization of Residual Taste by the Subject

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).

Time frame:
Between Day 13 and Day 15
Reported as:
Count of participants · Participants
Characterization of Residual Taste by the Subject
ParticipantsHealsea Rescue* GroupPlacebo Group
residual taste not pleasant43
residual taste neutral5961
residual taste pleasant2121
residual taste very pleasant1615
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Fisher Exact · p = 0.988One sided test
SecondaryCharacterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject

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).

Time frame:
Between Day 13 and Day 15
Reported as:
Count of participants · Participants
Characterization of Cleansing and Moistening of Nasal Mucosa With the Prescribed Treatment by the Subject
ParticipantsHealsea Rescue* GroupPlacebo Group
no improvement35
slight improvement1111
moderate improvement4737
very clear improvement3947
Statistical analysis
  • Healsea Rescue* Group vs Placebo Group · Fisher Exact · p = 0.483one sided test

Adverse events

Collected over throughout the study, up to day 15. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Healsea Rescue* Group0/100 (0%)0/100 (0%)10/100 (10%)
Placebo Group0/100 (0%)0/100 (0%)9/100 (9%)
Most frequent other events
Most frequent other events
EventHealsea Rescue* GroupPlacebo Group
pyrexiaGeneral disorders1/1006/100
paraesthesiaNervous system disorders3/1001/100
epistaxisRespiratory, thoracic and mediastinal disorders1/1001/100
nasal disconfortRespiratory, thoracic and mediastinal disorders1/1001/100
Application site disconfortGeneral disorders1/1000/100
Application site painGeneral disorders1/1000/100
rhinorrheaRespiratory, thoracic and mediastinal disorders1/1000/100
unpleasant and bitter feelingGeneral disorders1/1000/100
nasal cavity painGeneral disorders0/1001/100

Baseline characteristics

Full Analysis Set similar to Safety Population

Age, Continuous
Age, Continuous(Years)Healsea Rescue* GroupPlacebo GroupTotal
Mean36.1 ± 14.034.4 ± 13.435.3 ± 13.7
Sex: Female, Male
Sex: Female, Male(Participants)Healsea Rescue* GroupPlacebo GroupTotal
Female5754111
Male434689
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Healsea Rescue* GroupPlacebo GroupTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Healsea Rescue* GroupPlacebo GroupTotal
Bulgaria100100200
Total WURSS-21 score at baseline
Total WURSS-21 score at baseline(units on a scale)Healsea Rescue* GroupPlacebo GroupTotal
Mean37.7 ± 20.137.0 ± 18.237.4 ± 19.1
08

Study locations

1 site
  • DCC Convex Ltd.
    Sofia, 1000, Bulgaria
09

References and documents

Publications

  • Heikkinen T, Jarvinen A. The common cold. Lancet. 2003 Jan 4;361(9351):51-9. doi: 10.1016/S0140-6736(03)12162-9. PubMed 12517470 ↗
  • Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097. PubMed 25832968 ↗
  • Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600. PubMed 32077450 ↗
  • Rosenfeld RM. CLINICAL PRACTICE. Acute Sinusitis in Adults. N Engl J Med. 2016 Sep 8;375(10):962-70. doi: 10.1056/NEJMcp1601749. No abstract available. PubMed 27602668 ↗
  • Rabin N, Zheng Y, Opoku-Temeng C, Du Y, Bonsu E, Sintim HO. Biofilm formation mechanisms and targets for developing antibiofilm agents. Future Med Chem. 2015;7(4):493-512. doi: 10.4155/fmc.15.6. Erratum In: Future Med Chem. 2015;7(10):1362. doi: 10.4155/fmc.15.77. PubMed 25875875 ↗
  • King D, Mitchell B, Williams CP, Spurling GK. Saline nasal irrigation for acute upper respiratory tract infections. Cochrane Database Syst Rev. 2015 Apr 20;2015(4):CD006821. doi: 10.1002/14651858.CD006821.pub3. PubMed 25892369 ↗
  • Principi N, Esposito S. Nasal Irrigation: An Imprecisely Defined Medical Procedure. Int J Environ Res Public Health. 2017 May 11;14(5):516. doi: 10.3390/ijerph14050516. PubMed 28492494 ↗
  • Talbot AR, Herr TM, Parsons DS. Mucociliary clearance and buffered hypertonic saline solution. Laryngoscope. 1997 Apr;107(4):500-3. doi: 10.1097/00005537-199704000-00013. PubMed 9111380 ↗
  • Brown CL, Graham SM. Nasal irrigations: good or bad? Curr Opin Otolaryngol Head Neck Surg. 2004 Feb;12(1):9-13. doi: 10.1097/00020840-200402000-00004. PubMed 14712112 ↗
  • Rabago D, Zgierska A, Mundt M, Barrett B, Bobula J, Maberry R. Efficacy of daily hypertonic saline nasal irrigation among patients with sinusitis: a randomized controlled trial. J Fam Pract. 2002 Dec;51(12):1049-55. PubMed 12540331 ↗
  • van Haselen R, Thinesse-Mallwitz M, Maidannyk V, Buskin SL, Weber S, Keller T, Burkart J, Klement P. The Effectiveness and Safety of a Homeopathic Medicinal Product in Pediatric Upper Respiratory Tract Infections With Fever: A Randomized Controlled Trial. Glob Pediatr Health. 2016 Jul 4;3:2333794X16654851. doi: 10.1177/2333794X16654851. eCollection 2016. PubMed 27493984 ↗
  • Barrett B, Brown RL, Mundt MP, Thomas GR, Barlow SK, Highstrom AD, Bahrainian M. Validation of a short form Wisconsin Upper Respiratory Symptom Survey (WURSS-21). Health Qual Life Outcomes. 2009 Aug 12;7:76. doi: 10.1186/1477-7525-7-76. PubMed 19674476 ↗
  • Brown RL, Obasi CN, Barrett B. Rasch Analysis of The WURSS-21 Dimensional Validation and Assessment of Invariance. J Lung Pulm Respir Res. 2016;3(2):00076. doi: 10.15406/jlprr.2015.03.00076. Epub 2016 Apr 11. PubMed 27812536 ↗
  • JACKSON GG, DOWLING HF, SPIESMAN IG, BOAND AV. Transmission of the common cold to volunteers under controlled conditions. I. The common cold as a clinical entity. AMA Arch Intern Med. 1958 Feb;101(2):267-78. doi: 10.1001/archinte.1958.00260140099015. No abstract available. PubMed 13497324 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05819190
Lead sponsor
Lallemand Pharma AG
Responsible party
Sponsor
First posted
Apr 19, 2023
Start date
Dec 14, 2022
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023
Results posted
Oct 8, 2024
Last update
Oct 8, 2024

Study contacts

Emil KOLEV, MD
principal investigator · DCC Convex Ltd., Sofia, Bulgaria

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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