Multicenter clinical trial, phase III, controlled by active medicine, open, randomized, enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup). Posology: The medicine treat will be as follows: \- Notuss® syrup Age: 2-5 years / Dosage: 5,0 mL Age: 6-12 years / Dosage: 10,0 ml
Dropropizine: Age: 2 - 3 years / Dosage: 5,0 ml Age: 4 - 12 years / Dosage: 10,0 ml Pseudoephedrine hydrochloride + brompheniramine maleate: Age: 2 - 3 years / Dosage: 2,5 ml Age: 4 - 6 years / Dosage: 5,0 ml Age: 7 - 9 years / Dosage: 7,5 ml Age: 10 - 12 years / Dosage: 10,0 ml
Improvement of nasal congestion and cough
Participants were evaluated (by a parent/guardian/caregivers) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.
Time frame: Evaluated on the day 2 after beginning treatment
Improvement of nasal congestion and cough
Participants were evaluated (by a parent/guardian/caregivers) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.
Time frame: Evaluated on the 7(±1) day after beginning treatment
Improvement of non-obstructive nasal symptoms
Participants were evaluated (by a parent/guardian/caregivers for pain intensity by using a sum of 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.
Time frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
Reduction of the frequency of nighttime awakenings of parent/guardian/roommate of the child
Time frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
Reduction of vomiting frequency episodes triggered by coughing
Time frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
Improvement of acute rhinitis signs
Assessed by anterior rhinoscopy and application of specific clinical scores
Time frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
Use of rescue medication
Time frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall impression of improvement by the investigator
Specific scale and overall impression of improvement by a parent/guardian/ caregiver of the child
Time frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
Collection of safety data throughout the whole study period
Time frame: Will be evaluated during the 7(± 1) days of treatment