An observational study in Common Cold and Allergy, sponsored by Lallemand Pharma AG. Completed at 15 sites in Poland. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by Lallemand Pharma AG · Observational
Healsea® Children is a seawater-based nasal spray supplemented with a natural Symbiofilm® extract (0.02%) isolated from marine bacteria. Symbiofilm has antibiofilm activity against various bacterial pathogens involved in respiratory tract infections.Healsea® Children is indicated in the cleaning and moistening of nasal mucosa during common cold and rhinitis for children above 6 years.
This non interventional post-market clinical investigation aimed to confirm the benefit of Healsea® Children in real life setting in children with perennial allergy who are more prone to common cold.
Healsea® Children is a seawater-based nasal spray supplemented with a natural Symbiofilm® extract (0.02%) isolated from marine bacteria. Symbiofilm® is an exopolymeric composition with emulsifying properties, in vitro antibiofilm activity and detachment properties against various bacterial pathogens involved in respiratory tract infections. Symbiofilm® has no bacteriostatic nor bactericidal activities. Healsea® Children is indicated in the cleaning and moistening of nasal mucosa during common cold and rhinitis.
The common cold is an acute viral infection of the upper respiratory tract, involving, to variable degrees, sneezing, nasal congestion and discharge (rhinorrhea), sore throat, cough, low-grade fever, headache, and malaise (1). It can be caused by members of several families of viruses; the most common are rhinoviruses. Acute viral rhinitis is generally self-limiting. In children where the illness is not self-limiting and extends beyond 7-10 days, many agree that a bacterial infection is likely (1). 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 (2-3).
Allergic diseases may play a particular role in promoting the respiratory infection recurrences (4). The physiological immune response is impaired in allergic subjects and allergic inflammation favours predisposition to respiratory infections. Subjects with allergic disorders may have functional defect of type 1 immune response that is relevant in fighting infections (5-6).
Allergic rhinitis (AR) may affect up to 40% of the paediatric population. Nasal symptoms are caused by exposure to an allergen to which a patient is sensitized.
AR is characterized by typical nasal symptoms and immunoglobulin E (IgE) -mediated inflammation. The allergic inflammatory process releases many cytokines and other proinflammatory proteins. Inflammation caused by nasal allergy leads to obstruction, fluid accumulation and acute disease. If these diseases are unsuccessfully treated, a chronic state of inflammation, obstruction, and infection develops that can cause mucosal damage and, ultimately, chronic disease (7).
For these reasons, the paediatric IgE-dependent allergic population that is more prone to common cold represents a suitable target for Healsea® Children (8-9).
During this prospective post-market clinical investigation, IgE-dependent allergic children with early symptoms of infectious rhinitis will be followed, children being treated with Healsea® Children on top of common cold conventional therapies or with conventional therapies only (excluded nasal irrigation).
Conventional therapies for non-complicated infectious rhinitis are symptomatic but are not without side effects. For example, decongestant use can increase blood pressure, antihistamine intake is associated with drowsiness.
Healsea® Children represents an interesting alternative that can not only improve acute infectious rhinitis symptomatology but could also limit the complication and progression to chronic state.
This non interventional post-market clinical investigation aimed to confirm the benefit of Healsea® Children in a real life setting in children with perennial allergy.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's enrollment of 186 is above the median of 114 across 25 observational studies indexed under Common Cold.
Browse Common Cold studies →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.
The study population comprises children 6 to10 years old with perennial allergy and early symptoms of common cold.
The recruitment will be competitive in both group, exposed to Healsea® Children or not exposed to Healsea® Children. However, when 100 patients will be recruited in one group, the recruitment will be stopped in this group but will continue in the other group until 100 patients to be enrolled.
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.
Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children will receive Healsea® Children nasal spray on top of conventional therapies for common cold, as needed.
Device: Healsea® Children · Other: Conventional therapies for common cold
Children will receive conventional therapies for common cold as needed, nasal irrigation excluded
Other: Conventional therapies for common cold
Children will be administered Healsea Children , one puff (1-2 sec) in each nostril twice a day for 10 days on top of conventional therapies, as needed
Also known as: Conventional therapies for common cold
Children will receive conventional therapies for common cold, nasal irrigation excluded (antipyretics, mucolytics, decongestants, antitussives, systemic and topical corticosteroids, antibiotics)
AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period
The WURSS-K will be assessed once daily, from Day1 to Day10 (treatment period) WURSS-K is a 3-dimensional structure questionnaire specifically designed for children 4 to 10 years of age. It includes 6 items assessing symptoms (symptoms score: runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired), 7 items assessing functional impairments (quality of life score: think, sleep, breathe, talk, walk/climb stairs/exercise, go to school, play with friends), 1 item assessing global severity. All these items are scored from 0 (absent or no impairment) through 1 (a little bad), 2 (bad) and 3 (very bad). The AUC value of the WURSS-K during the 10 day- treatment period is comprised between 0 WURSS-K score\*day (no impairement) and 420 WURSS-K score \*day (maximal impairement)
Time frame: Cumulative AUC of the WURSS score assessed from Day 1 to Day 10
Number of Days With Runny Nose
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Runny nose is the item 2
Time frame: Number of days with runny nose during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With Stuffy Nose
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Stuffy nose is the item 3.
Time frame: Number of days with stuffy nose during the 10-day treatment period and a follow-up period of 20 days, up to 30 days
Number of Days With Sneezing
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of common cold symptoms in both groups. Sneezing is the item 4.
Time frame: Number of days with sneezing during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With Sore Throat
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Sore throat is the item 5.
Time frame: Number of days with sore throat during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With Cough
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Cough is the item 6.
Time frame: Number of days with cough during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Number of Days With "Feeling Tired"
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Feeling tired is the item 7.
Time frame: Number of days with "feeling tired" during the 10-day treatment period and a follow-up of 20 days, up to 30 days
Respiratory Complication Requiring Antibiotic Prescription After the10-day Treatment Period
The number of subjects who develop respiratory complication requiring antibiotic prescription during a 20-day follow-up period after the treatment period will be assessed in both groups and compared
Time frame: Number of subjects with respiratory complications during the 20-day follow-up period
Number of Participants With Use of Concomitant Treatments
Number of subjects who took at least one concomitant treatment (antibiotics, antipyretics, systemic or local mucolytics, decongestants, antitussives, systemic and topical corticosteroids) that may impact symptoms of common cold and comparaison between groups
Time frame: During 10-day treatment period and a follow-up period of 20 days, up to 30 days
Participants were outpatients visiting a physician in Polish hospitals or private practices at the onset of a common cold. The first patient was screened and enrolled on 14th of February 2022 and the last patient on 20th October 2022.
| Milestone | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies |
|---|---|---|
| Started | 101 | 85 |
| Full analysis set (fas) | 101 | 85 |
| Per protocol set (pp) | 91 | 76 |
| Completed | 100 | 75 |
| Not completed | 1 | 10 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 10 |
The WURSS-K will be assessed once daily, from Day1 to Day10 (treatment period) WURSS-K is a 3-dimensional structure questionnaire specifically designed for children 4 to 10 years of age. It includes 6 items assessing symptoms (symptoms score: runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired), 7 items assessing functional impairments (quality of life score: think, sleep, breathe, talk, walk/climb stairs/exercise, go to school, play with friends), 1 item assessing global severity. All these items are scored from 0 (absent or no impairment) through 1 (a little bad), 2 (bad) and 3 (very bad). The AUC value of the WURSS-K during the 10 day- treatment period is comprised between 0 WURSS-K score\*day (no impairement) and 420 WURSS-K score \*day (maximal impairement)
| scores on WURSS-K scale* days | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies |
|---|---|---|
| AUC (Area Under Curve) of the Wisconsin Upper Respiratory Symptoms Survey for Kids (WURSS-K) During the 10-day Treatment Period | 36.56 ± 21.14 | 55.54 ± 27.86 |
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Runny nose is the item 2
| Day | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies |
|---|---|---|
| Number of Days With Runny Nose | 7.4 ± 6.9 | 9.4 ± 7.9 |
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Stuffy nose is the item 3.
| Day | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies |
|---|---|---|
| Number of Days With Stuffy Nose | 6.8 ± 6.3 | 8.6 ± 7.5 |
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of common cold symptoms in both groups. Sneezing is the item 4.
| Day | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies |
|---|---|---|
| Number of Days With Sneezing | 6.1 ± 6.5 | 5.9 ± 6.0 |
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Sore throat is the item 5.
| Day | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies |
|---|---|---|
| Number of Days With Sore Throat | 3.9 ± 5.6 | 5.2 ± 6.9 |
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Cough is the item 6.
| Day | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies |
|---|---|---|
| Number of Days With Cough | 6.1 ± 6.2 | 7.1 ± 7.2 |
During the treatment period, the WURSS-K will be assessed once daily. After D10, the WURSS-K will be assessed once daily until the subject feels not sick for two consecutive days. Items 2 to 7 will be used to assess the duration of each common cold symptoms in both groups. Feeling tired is the item 7.
| Day | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies |
|---|---|---|
| Number of Days With "Feeling Tired" | 4.8 ± 6.2 | 6.4 ± 7.3 |
The number of subjects who develop respiratory complication requiring antibiotic prescription during a 20-day follow-up period after the treatment period will be assessed in both groups and compared
| Participants | Conventional Therapies | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract |
|---|---|---|
| Respiratory Complication Requiring Antibiotic Prescription After the10-day Treatment Period | 1 | 2 |
Number of subjects who took at least one concomitant treatment (antibiotics, antipyretics, systemic or local mucolytics, decongestants, antitussives, systemic and topical corticosteroids) that may impact symptoms of common cold and comparaison between groups
| participants | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies |
|---|---|---|
| Number of Participants With Use of Concomitant Treatments | 53 | 66 |
Collected over Adverse events were collected during a 10-day treatment period and a follow-up period of 20 days, up to 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | 0/101 (0%) | 0/101 (0%) | 17/101 (16.8%) |
| Conventional Therapies | 0/85 (0%) | 0/85 (0%) | 23/85 (27.1%) |
| Event | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies |
|---|---|---|
| coughRespiratory, thoracic and mediastinal disorders | 5/101 | 11/85 |
| PyrexiaGeneral disorders | 5/101 | 3/85 |
| PharyngitisInfections and infestations | 2/101 | 4/85 |
| Nasal obstructionRespiratory, thoracic and mediastinal disorders | 2/101 | 3/85 |
| Ear painEar and labyrinth disorders | 0/101 | 3/85 |
| RhinorrheaRespiratory, thoracic and mediastinal disorders | 1/101 | 2/85 |
| Rhinitis allergicRespiratory, thoracic and mediastinal disorders | 0/101 | 2/85 |
| BronchitisInfections and infestations | 1/101 | 2/85 |
| RhinitisInfections and infestations | 1/101 | 2/85 |
| HeadacheNervous system disorders | 1/101 | 2/85 |
| Age, Continuous(Years) | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies | Total |
|---|---|---|---|
| Mean | 7.86 ± 1.42 | 8.02 ± 1.40 | 7.93 ± 1.41 |
| Sex: Female, Male(Participants) | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies | Total |
|---|---|---|---|
| Female | 45 | 36 | 81 |
| Male | 56 | 49 | 105 |
| Race (NIH/OMB)(Participants) | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 101 | 85 | 186 |
| Region of Enrollment(participants) | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies | Total |
|---|---|---|---|
| Poland | 101 | 85 | 186 |
| Symptoms of acute rhinitis at baseline: temperature(Degrees Celcius) | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies | Total |
|---|---|---|---|
| Mean | 37.75 ± 0.23 | 37.81 ± 0.39 | 37.78 ± 0.31 |
| Symptoms of acute rhinitis at baseline(units on a scale) | Healsea® Children: Isotonic Seawater Based Nasal Spray Supplemented With Natural Symbiofilm® Extract | Conventional Therapies | Total |
|---|---|---|---|
| Headache | 0.6 ± 0.6 | 0.5 ± 0.6 | 0.6 ± 0.6 |
| Muscle ache | 0.1 ± 0.4 | 0.2 ± 0.5 | 0.2 ± 0.4 |
| Chiliness | 0.2 ± 0.4 | 0.3 ± 0.5 | 0.2 ± 0.5 |
| Sore throat | 0.8 ± 0.7 | 0.8 ± 0.7 | 0.8 ± 0.7 |
| Blocked nose | 1.7 ± 0.7 | 1.6 ± 0.8 | 1.7 ± 0.7 |
| Runny nose | 1.5 ± 0.7 | 1.5 ± 0.7 | 1.5 ± 0.7 |
| Cough | 0.9 ± 0.8 | 1.1 ± 1.0 | 1.0 ± 0.9 |
| Sneezing | 1.0 ± 0.7 | 0.9 ± 0.7 | 1.0 ± 0.7 |
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Lallemand Pharma AG