Testing the Efficacy in Adults With Cold of HEalsea Rescue*

Common Cold Clinical Trial

— TEACHER  

Official title:

Efficacy and Safety of Healsea® Hypertonic Nasal Spray 2.7% in the Treatment of Acute Infectious Rhinitis in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05819190
• Other study ID #: LPH-2201
• Status: Completed
• Phase: N/A
• Start date: December 14, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2023
• Source: Lallemand Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 informed consent and has received a signed and dated copy of the information consent form

6. Patient with a smartphone and an internet connection.

Exclusion Criteria:

1. Known hypersensitivity/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 corticosteroids (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 contraception

Related Conditions & MeSH terms

• Common Cold

Intervention

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

Locations

Country	Name	City	State
Bulgaria	DCC Convex Ltd.	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Lallemand Pharma AG

Country where clinical trial is conducted

Bulgaria, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Heikkinen T, Jarvinen A. The common cold. Lancet. 2003 Jan 4;361(9351):51-9. doi: 10.1016/S0140-6736(03)12162-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (Area Under Curve) of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) during first 8 days of symptoms will be compared between both groups	The WURSS-21 will be assessed 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 Day1, the WURSS-21 will be completed during the visit. After Day 8, the WURSS-21 will be assessed once daily until the subject feels not sick for two consecutive days.	Treatment period, from Day 1 to Day 8
Secondary	AUC of the symptoms sub-score (items 2-11) of the WURSS-21 during first 8 days	The WURSS-21 will be assessed 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 will be completed during the visit. After Day 8, the WURSS-21 will be assessed once daily until the subject feels not sick for two consecutive days.	Treatment period, from Day 1 to Day 8
Secondary	AUC of the Quality of Life sub-score (items 12-20) of the WURSS-21 during first 8 days	The WURSS-21 will be assessed 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 will be completed during the visit. After Day 8, the WURSS-21 will be assessed once daily until the subject feels not sick for two consecutive days.	Treatment period, from Day 1 to Day 8
Secondary	Duration of cold symptoms assessed by means of the WURSS-21	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
Secondary	Frequency and number of days of concomitant treatments use that may affect common cold symptoms	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
Secondary	Subject satisfaction regarding ease of use, efficacy, local tolerance and tasteglobal and subject feedback on treatment use	At end of study visit (V2) subject satisfaction regarding ease of use, efficacy, local tolerance and taste will be recorded using a 4-points categorical scale.; The global subject feedback on treatment use will be assessed through the question: "Will you recommend the prescribed treatment for treatment / prevention of acute rhinitis?".	Between Day 13 and Day 15
Secondary	Reporting of adverse events and incidents	Assessment of adverse events and incidents throughout the study	Through study completion, up to Day 15