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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.
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 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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healsea Rescue* group | Experimental | Subjects will receive Healsea Rescue* according to its intended use. |
|
| Placebo group | Placebo Comparator | Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healsea Rescue* | Device | Subjects will be administered with Healsea Rescue* by spraying 2 puffs in each nostril 2 times per day during 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Treatment period, from Day 1 to Day 8 |
| 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. | Treatment period, from Day 1 to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emil KOLEV, MD | DCC Convex Ltd., Sofia, Bulgaria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DCC Convex Ltd. | Sofia | 1000 | Bulgaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12517470 | Background | Heikkinen T, Jarvinen A. The common cold. Lancet. 2003 Jan 4;361(9351):51-9. doi: 10.1016/S0140-6736(03)12162-9. | |
| 25832968 | Background | 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. |
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First patient first visit: 14th December 2022 Last patient last visit: 31 th January 2023 Location: Bulgaria, 1 site
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| ID | Title | Description |
|---|---|---|
| FG000 | Healsea Rescue* Group | Subjects will receive Healsea Rescue* according to its intended use. Healsea Rescue*: Subjects will be administered with Healsea Rescue* by spraying 2 puffs in each nostril 2 times per day during 7 days. |
| FG001 | Placebo Group | Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue. Placebo: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set similar to Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Healsea Rescue* Group | Subjects will receive Healsea Rescue* according to its intended use. Healsea Rescue*: Subjects will be administered with Healsea Rescue* by spraying 2 puffs in each nostril 2 times per day during 7 days. |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Score on a scale*day | Treatment period, from Day 1 to Day 8 |
throughout the study, up to day 15
Reporting of Adverse events, incidents ( as per EU regulation 2017/745 requirements) and expected side effects
Incident:
Means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.
Expected side effects:
identified in the manufacturer's labelling
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healsea Rescue* Group | Subjects will receive Healsea Rescue* according to its intended use. Healsea Rescue*: Subjects will be administered with Healsea Rescue* by spraying 2 puffs in each nostril 2 times per day during 7 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment | adverse event |
There are two limitations of this investigation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Bernard Gout Organization | Pharmndev Experts | +41798659000 | Email:bgout@pharmndev.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 3, 2022 | Jan 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2023 | Jan 5, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| D000096825 | Rhinosinusitis |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Placebo | Device | 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. |
|
| Treatment period, from Day 1 to Day 8 |
| 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 | Treatment period, from Day 1 to Day 8 |
| 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. | Through study completion, up to Day 15 |
| 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. | Through study completion, up to Day 15 |
| 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. | Through study completion, up to Day 15 |
| 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. | Through study completion, up to Day 15 |
| 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. | Through study completion, up to Day 15 |
| 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. | Through study completion, up to Day 15 |
| 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. | Through study completion, up to Day 15 |
| 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. | Through study completion, up to Day 15 |
| 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. | Through study completion, up to Day 15 |
| 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. | Through study completion, up to Day 15 |
| 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. | Through study completion, up to Day 15 |
| 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). | Between Day 13 and Day 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). | Between Day 13 and Day 15 |
| 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). | Between Day 13 and Day 15 |
| 32077450 | Background | 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. |
| 27602668 | Background | 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. |
| 25875875 | Background | 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. |
| 25892369 | Background | 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. |
| 28492494 | Background | 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. |
| 9111380 | Background | 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. |
| 14712112 | Background | 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. |
| 12540331 | Background | 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. |
| 27493984 | Background | 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. |
| 19674476 | Background | 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. |
| 27812536 | Background | 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. |
| 13497324 | Background | 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. |
Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue. Placebo: 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total WURSS-21 score at baseline | Wisconsin Upper Respiratory Symptoms Survey- 21 completed by each subject at baseline. Minimal score 0, maximal score 140 (each item is scored from 0 to 7, no symptom/not sick=0 and severe symptom/severely sick =7) | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Healsea Rescue* Group | Subjects will receive Healsea Rescue* according to its intended use. Healsea Rescue*: Subjects will be administered with Healsea Rescue* by spraying 2 puffs in each nostril 2 times per day during 7 days. |
| OG001 | Placebo Group | Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue. Placebo: 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. |
|
|
|
| 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) | 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. | Per Protocol Set (PP) | Posted | Mean | Standard Deviation | score on a scale*day | Treatment period, from Day 1 to Day 8 |
|
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| Secondary | 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. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | score on a sub-scale*day | Treatment period, from Day 1 to Day 8 |
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| Secondary | 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 | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | score on a sub-scale*day | Treatment period, from Day 1 to Day 8 |
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | days | Through study completion, up to Day 15 |
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | days | Through study completion, up to Day 15 |
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | days | Through study completion, up to Day 15 |
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | days | Through study completion, up to Day 15 |
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | days | Through study completion, up to Day 15 |
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | days | Through study completion, up to Day 15 |
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | days | Through study completion, up to Day 15 |
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | days | Through study completion, up to Day 15 |
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | days | Through study completion, up to Day 15 |
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| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | days | Through study completion, up to Day 15 |
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| Secondary | 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. | Full Analysis set | Posted | Number | days | Through study completion, up to Day 15 |
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| Secondary | 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). | Full Analysis Set | Posted | Count of Participants | Participants | Between Day 13 and Day 15 |
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| Secondary | 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). | Full Analysis Set | Posted | Count of Participants | Participants | Between Day 13 and Day 15 |
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| Secondary | 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). | Full Analysis Set | Posted | Count of Participants | Participants | Between Day 13 and Day 15 |
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| 0 |
| 100 |
| 0 |
| 100 |
| 10 |
| 100 |
| EG001 | Placebo Group | Subjects will receive Placebo according to identical posology, instructions for use, contraindication, precaution of use and labelling to those of Healsea Rescue. Placebo: 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. | 0 | 100 | 0 | 100 | 9 | 100 |
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment | Incident as per regulation EU 2017/745 |
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| nasal disconfort | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment | Expected side effect. Did not lead to study or device discontinuation |
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| Application site disconfort | General disorders | MedDRA 25.0 | Systematic Assessment | Expected side effect. Did not lead to study or device discontinuation |
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| Application site pain | General disorders | MedDRA 25.0 | Systematic Assessment | Expected side effect. Did not lead to study or device discontinuation |
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| paraesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment | Expected side effect. Did not lead to study or device discontinuation |
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| rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment | Incident as per regulation EU 2017/745. Did not lead to study or device discontinuation |
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| unpleasant and bitter feeling | General disorders | MedDRA 25.0 | Systematic Assessment | Incident as per regulation EU 2017/745. Did not lead to study or device discontinuation |
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| nasal cavity pain | General disorders | MedDRA 25.0 | Systematic Assessment | Incident as per regulation EU 2017/745. Did not lead to study or device discontinuation |
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Not provided
| D012140 |
| Respiratory Tract Diseases |
| D012220 | Rhinitis |
| D012852 | Sinusitis |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| use easy |
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| use very easy |
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| residual taste pleasant |
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| residual taste very pleasant |
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| moderate improvement |
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| very clear improvement |
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