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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Notuss® syrup | Experimental | Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup). |
|
| Dropropizine + Pseudoephedrine and brompheniramine | Active Comparator | Group 2: combined use of dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diphenhydramine + dropropizine + pseudoephedrine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluated on the day 2 after beginning treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluated on the 7(±1) day after beginning treatment |
| Improvement of non-obstructive nasal symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir). | Drug | 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 |
|
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. |
| 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 | Evaluated on the day 2 and 7 (±1) after beginning treatment |
| Reduction of vomiting frequency episodes triggered by coughing | 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 | Evaluated on the day 2 and 7 (±1) after beginning treatment |
| Use of rescue medication | Evaluated on the day 2 and 7 (±1) after beginning treatment |
| Overall impression of improvement by the investigator | Specific scale and overall impression of improvement by a parent/guardian/ caregiver of the child | 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 | Will be evaluated during the 7(± 1) days of treatment |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D003371 | Cough |
| D012220 | Rhinitis |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D004155 | Diphenhydramine |
| C035916 | dipropizine |
| D054199 | Pseudoephedrine |
| D001977 | Brompheniramine |
| ID | Term |
|---|---|
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D010627 | Phenethylamines |
| D010632 | Pheniramine |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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