BАbykids Spray In Common Cold (BASICC)

• ClinicalTrials.gov Identifier: NCT05819203
• Recruitment Status: Completed
• First Posted: April 19, 2023
• Last Update Posted: July 25, 2023
• Sponsor: Lallemand Pharma AG
• Information provided by (Responsible Party): Lallemand Pharma AG

Study Description

Brief Summary:

The purpose of this post market clinical investigation is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo in children above 2 years.

Condition or disease	Intervention/treatment	Phase
Common Cold; Rhinitis Viral	Device: Healsea Babykids; Device: Placebo	Not Applicable

Detailed Description:

Healsea® Babykids is an isotonic saline solution based nasal spray supplemented with a natural Symbiofilm® extract (0.04%) isolated from marine bacteria. Symbiofilm® has in vitro antibiofilm activity and protects in vitro human nasal epithelial cells viability after Rhinovirus, Adenovirus, coronavirus OC43 and flu infection.

Healsea® Babykids is a nasal spray indicated in children above 2 years to clean and moisten the nose during colds 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. 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. 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 aim of this study is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo.

The study comprises 2 parts:

- Part 1 (Day 1-Day 11): treatment of the acute phase

• with Healsea® Babykids, 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes of Healsea® Babykids) up to 10 days (20 intakes of the investigational device).

or • with isotonic nasal spray (Placebo), 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes of Placebo) up to 10 days (20 intakes of the investigational device).

- Part 2 (up to Day 15/Day 18): follow-up phase.

The study comprises two visits:

• Visit 1 (V1) at Day 1
• End of study visit (Visit 2, V2) between Day 15 and Day 18

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial double blind
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: The investigational device and the comparator were indistinguishable. The comparator (isotonic nasal spray) used the same technology and the same packaging than Healsea Babykids. A white label with regulatory mentions for clinical investigations was stuck on the vial A white label with regulatory mentions was sticked on a white cardboard box used as secondary packaging. The IFUs (Bulgarian version) was included in the secondary packaging (on one face, Healsea Babykids, on the other face Placebo
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Healsea® Babykids in the Treatment of Acute Infectious Rhinitis Symptoms in Children
• Actual Study Start Date: February 13, 2023
• Actual Primary Completion Date: May 16, 2023
• Actual Study Completion Date: May 16, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Healsea Babykids; Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).	Device: Healsea Babykids; 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
Placebo Comparator: Placebo; The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).	Device: Placebo; 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .

Outcome Measures

Primary Outcome Measures :

1. The area under the curve (AUC) of the global score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) during first 10 days of symptoms [ Time Frame: From Day 1 to Day 10 ]
   ARSSQ is a non-validated customized questionnaire . It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening.

Secondary Outcome Measures :

1. Duration of each cold symptom (questions 2 to 7 of the ARSSQ) in both groups [ Time Frame: Through study completion, up to Day 18 ]

   For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days.

   Duration may be censored at Visit 2.

2. Duration of quality-of-life impairment (questions 8 to 10 of the ARSSQ). [ Time Frame: Through study completion, up to Day 18 ]

   For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days.

   Duration may be censored at Visit 2.

3. Frequency and number of days of concomitant treatments use that may affect common cold symptoms (antibiotics, antipyretics, systemic or local mucolytics, decongestants, antitussives, systemic and topical corticosteroids) [ Time Frame: Through study completion, up to Day 18 ]
   Concomitant treatments use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF.
4. Safety: adverse events and incidents throughout the study [ Time Frame: Through study completion, up to Day 18 ]
   Assessment of adverse event related to acute rhinitis and incidents throughout the study in both groups.

Eligibility Criteria

• Ages Eligible for Study: 25 Months to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 1. Male/Female subjects >2 and ≤6-year-old
• 2. Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
• 3. Patient presenting with fever ≥ 37.5 °C at screening
• 4. Subjects with nasal congestion (blocked / stuffy nose) rated at least as moderate on the Acute Rhinitis Symptoms Severity Questionnaire, based on evaluation by the investigator
• 5. Subjects showing at least moderate grade for at least one of the following additional signs of acute rhinitis: runny nose, nasal crust (dry mucus), sneezing and cough
• 6. Written consent obtained from parent/legal guardians

Exclusion Criteria:

• 1. Known hypersensitivity/allergy to any component of the test device
• 2. Medical history 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 corticosteroids within 4 weeks before screening
• 7. Chronic decongestant use
• 8. Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence ARSSQ score at screening (NSAID, nasal decongestants, cough medicines)

Contacts and Locations

Locations

Bulgaria

Medical center

Plovdiv, Bulgaria

Medical center

Sofia, Bulgaria

Medical center

Vratsa, Bulgaria

Sponsors and Collaborators

Lallemand Pharma AG

Investigators

• Principal Investigator: Rada MARKOVA, MD; Medical Center, Sofia

More Information

Publications of Results:

Passioti M, Maggina P, Megremis S, Papadopoulos NG. The common cold: potential for future prevention or cure. Curr Allergy Asthma Rep. 2014 Feb;14(2):413. doi: 10.1007/s11882-013-0413-5.

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.

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

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.

• Responsible Party: Lallemand Pharma AG
• ClinicalTrials.gov Identifier: NCT05819203
• Other Study ID Numbers: LPH-2202
• First Posted: April 19, 2023
• Last Update Posted: July 25, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lallemand Pharma AG:

nasal spray; supplemented isotonic saline solution; infectious rhinitis; children

Additional relevant MeSH terms:

Rhinitis; Common Cold; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases