N/A N=200 Randomized Triple-blind Treatment

BАbykids Spray In Common Cold

Common Cold · Rhinitis Viral

Bottom Line

View on ClinicalTrials.gov: NCT05819203 ↗

Enrolled (actual)

200

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: 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) — 78.1; 93.6 score on a scale*day — p=0.0013

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Healsea Babykids (Device); Placebo (Device)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Lallemand Pharma AG
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	78.1; 93.6	0.0013 sig
PRIMARY 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)	80.5; 96	0.0034 sig
SECONDARY Duration of Each Cold Symptom (Questions 2 to 7 of the ARSSQ) in Both Groups	6.92; 7.61	0.0209 sig
SECONDARY Duration of Quality-of-life Impairment (Questions 8 to 10 of the ARSSQ).	6.46; 7.03	0.0399 sig
SECONDARY 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)	317; 389	0.0015 sig
SECONDARY Cumulative Number of Days of Antibiotics Intake	108; 127	>0.05
SECONDARY Cumulative Number of Days of Antipyretics Intake	62; 86	0.0029 sig
SECONDARY Cumulative Number of Days of Mucolytics Intake	44; 85	0.0006 sig
SECONDARY Cumulative Number of Days of Decongestants Use	149; 220	0.0513
SECONDARY Cumulative Number of Days of Antitussives Use	23; 18	0.0789
SECONDARY Cumulative Number of Days of Systemic and Topical Corticosteroids Use	25; 66	<0.0001 sig

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.

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05819203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.