BАbykids Spray In Common Cold

NCT05819203 | Completed Results

• 1 other identifier: LPH-2202
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Common Cold; Rhinitis Viral

Keywords

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

Outcome Measures

Primary Outcomes (2)

• The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Full Analysis Set (FAS)

  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. The minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30).

  From Day 1 to Day 10

• The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Per Protocol Set (PP)

  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. The minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30).

  From Day 1 to Day 10

Secondary Outcomes (9)

• Duration of Each Cold Symptom (Questions 2 to 7 of the ARSSQ) in Both Groups

  Through study completion, up to Day 18

• Duration of Quality-of-life Impairment (Questions 8 to 10 of the ARSSQ).

  Through study completion, up to Day 18

• Cumulative 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)

  Through study completion, up to Day 18

• Cumulative Number of Days of Antibiotics Intake

  through study completion , up to day 18

• Cumulative Number of Days of Antipyretics Intake

  through study completion, up to day 18

Study Arms (2)

Healsea Babykids

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Healsea Babykids DEVICE

7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .

Healsea Babykids

Placebo DEVICE

7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .

Placebo

Eligibility Criteria

• Age: 25 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Male/Female subjects \>2 and ≤6-year-old
• \. Acute infectious rhinitis/rhinosinusitis for ≤48h before trial entry
• \. Patient presenting with fever ≥ 37.5 °C at screening
• \. 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
• \. 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
• \. Written consent obtained from parent/legal guardians

You may not qualify if:

• \. Known hypersensitivity/allergy to any component of the test device
• \. 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 corticosteroids within 4 weeks before screening
• \. Chronic decongestant use
• \. 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)

Sponsors & Collaborators

• Lallemand Pharma AG: lead

Study Sites (3)

Medical center

Plovdiv, Bulgaria

Location

Medical center

Sofia, Bulgaria

Location

Medical center

Vratsa, Bulgaria

Location

Related Publications (4)

• 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.

  PMID: 24415465 RESULT

• 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.

  PMID: 32077450 RESULT

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

  PMID: 12517470 RESULT

• 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.

  PMID: 28492494 RESULT

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

In the absence of validated questionnaire assessing the severity and functional impact of an acute infectious rhinitis in young children, we used a customized non validated questionnaire, the ARSSQ (Acute Rhinitis Symptoms Severity Questionnaire).

Results Point of Contact

• Title: Dr Bernard Gout
• Organization: Pharmndev Experts

bgout@pharmndev.ch

+41798659000

Study Officials

• Rada MARKOVA, MD

  Medical Center, Sofia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial double blind

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 19, 2023
• Study Start: February 13, 2023
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (3)