Common ColdTEACHERNCT05819190
Testing the Efficacy in Adults With Cold of HEalsea Rescue*
A study testing Healsea Rescue* in people with Common Cold, run by Lallemand Pharma AG at 1 site in Bulgaria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Cold
- What is being tested?
- Healsea Rescue*
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBulgaria
- Study dates
- 14 Dec 2022to 31 Jan 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/Female subjects >18 years
- Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
- Symptoms of headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, sneezing with a score ≤9 (according to a self-rated symptom score; scale: 0 → 3 [0: no symptom to 3: severe intensity])
- At least one of these symptoms: sore throat, runny nose or blocked nose (i.e., with a score ≥1)
- Willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the information consent form
- Patient with a smartphone and an internet connection.
Who cannot join
- Known hypersensitivity/allergy to any component of the test device
- Medical history or any current disease that is considered by the investigator as a reason for non-inclusion
- Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps
- History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores
- Antibiotic intake within 2 weeks before screening
- Systemic or local corticosteroids (nasal route or inhalation) within 4 weeks before screening
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- Antihistamines intake for allergy when treatment was started from less than 4 weeks
- Chronic decongestant use
- 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)
- Pregnant/Lactating female or absence of efficient contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Healsea® Hypertonic Nasal Spray 2.7% in the Treatment of Acute Infectious Rhinitis in Adults
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.
- Conditions
- Common Cold
- Being tested
- Healsea Rescue*, Placebo
- Keywords
- Acute infectious rhinitis, Rhinosinusitis, Respiratory tract infection, Nasal irrigation
- Medical subject headings
- Common Cold, Rhinosinusitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healsea Rescue*Device
Subjects will be administered with Healsea Rescue* by spraying 2 puffs in each nostril 2 times per day during 7 days.
PlaceboDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healsea Rescue* group | Experimental | Subjects will receive Healsea Rescue* according to its intended use. Receives: Device: Healsea Rescue* |
| 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. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Treatment period, from Day 1 to Day 8
Secondary outcomes (16)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Between Day 13 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start14 Dec 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emil KOLEV, MD, Principal investigator, DCC Convex Ltd., Sofia, Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819190
- Sponsor's protocol ID
- LPH-2201
- Acronym
- TEACHER
- Status last verified
- Jan 2024
- First submitted
- 9 Mar 2023
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 12517470Rosenfeld 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 25832968Fokkens 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 32077450Rosenfeld 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 27602668Rabin 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.
PubMed 25875875King 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 25892369Principi 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 28492494Talbot 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 9111380Brown 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 14712112Rabago 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 12540331van 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 27493984Barrett 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 19674476Brown 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 27812536JACKSON 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