A Trial to Evaluate Efficacy and Safety of a Nasal Spray Combined With Standard of Care for Nasal Congestion in Infants and Toddlers With Common Cold in Comparison to Standard of Care Alone
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nasal Congestion
- Sponsor
- Church & Dwight Company, Inc.
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Change of nasal congestion
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The study will evaluate the safety and efficacy of the study medical device plus standard of care versus standard of care in subjects between 3 and 48 months (inclusive) presenting symptoms of a common cold.
Detailed Description
The purpose of the present study is to test the efficacy, safety and tolerability of a product in relieving the symptoms of the common cold in children. This nasal spray is specifically studied for small children, classified as medical devices and is already on the market. Sterimar Blocked Nose Baby (CDEU048-28) nasal spray is a medical device and is a 100 ml bag-on-valve spray. The spray contains hypertonic solution based on 100% natural sea water rich of marine trace elements with added manganese and copper. 220 subjects will be included in this open label, randomized, parallel group, study product and standard of care versus standard of care study. Study product will be used as 1 to 2 sprays per nostril (each "dose" is 1 or 2 sprays per nostril, the second spray only if needed), for a minimum of 2 times (morning and evening) and, as needed, up to a maximum of 6 times per day (i.e., maximum 12 sprays per nostril each day). The 10 day study consists of 4 visits- Day 0 onsite, Days 3 and 6 telephone contact, and Day 10 onsite. There will be 3 strata according to age: (3-12 months), (13-24 months) and (25-48 months). Every effort will be made to ensure at least 20% of subjects in each of the study groups are 3-12 months of age.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female infants and toddlers.
- •Aged 3 - 48 months (inclusive) at enrolment (Day 0).
- •Parent/legal guardian answering "yes" to the question "Do you feel that your child has a cold?" at enrolment.
- •Subjects with symptoms started not later than 48 hours prior to enrolment (Day 0).
- •Subjects with nasal congestion (blocked / stuffy nose) rated as at least score of 2 (moderately bothersome) on a 0 to 3-point scale, based on morning evaluation (within an hour of child awakening).
- •Subjects showing at least one of the following additional signs of cold symptoms: runny nose, nasal crust (dry mucus), thick mucus, sneezing and cough.
- •Parent/legal guardian of the subject has given freely and expressly her/his informed consent.
- •Parent/legal guardian is cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol established by the clinical trial center could be expected.
Exclusion Criteria
- •Subjects presenting an oral temperature greater than 38°C at enrolment (Day 0).
- •Subjects presenting any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, etc.) at enrolment (Day 0).
- •Subjects with positive results on a streptococcal antigen screening test (rapid antigen detection test or RADT) at inclusion.
- •Subjects with a history of allergic rhinitis
- •Subjects presenting any congenital or chronic disease that in the opinion of the Investigator would adversely affect the results of the study (e.g. asthma, pneumonia, laryngotracheobronchitis, sinusitis, etc).
- •Subjects presenting any kind of immunodeficiency.
- •Subjects presenting any hypersensitivity or allergy or intolerance to any component of the study products or of the rescue medication (paracetamol)
- •Subjects with a positive medical history to any significant illness within the 2 weeks prior to the enrolment (Day 0).
- •Subjects presenting any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
- •Subjects currently participating or having participated in another clinical trial during the last 30 days prior to enrolment (Day 0).
Outcomes
Primary Outcomes
Change of nasal congestion
Time Frame: Through study completion, an average of 10 days.
Assess reduction of nasal congestion, evaluated by means of a specific questionnaire ("Cold Symptom Severity Questionnaire") on a 0 to 3-point scale, with higher score indicating a worse outcome, with 0 =not at all, 1=mild, 2=moderate and 3=severe to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons between groups.
Secondary Outcomes
- Change of other cold symptoms(Through study completion, an average of 10 days.)
- Occurrence of secondary infections(Through study completion, an average of 10 days.)