Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter clinical trial, phase III, superiority, controlled by active medicine, double-blind, randomized, enroll 166 children, over 12 years old, with acute inflammation upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Fixed dose combination of brompheniramine + phenylephrine. |
|
| Group 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 | Drug | Brompheniramine + phenylephrine |
| |
| Group 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of nasal congestion and runny nose, after 48 hours of treatment | Improvement is defined as a reduction of at least one point on the rating scale, in both nasal symptoms, after 48 hours of treatment. Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. | 48 hours after single dose of double-blind treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall score of nasal and extranasal symptoms (nasal congestion, runny nose, sneezing, watery eyes and itching) | After 2 and 5 (± 1) days of treatment. | |
| Clinical score of upper airway compromise | After 2 and 5 (± 1) days of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fábio M Castro | IMA | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| D007249 | Inflammation |
| D012220 | Rhinitis |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo |
|
| Proportion of subjects who used at least once the rescue medication | Within 2 days and the period of 5 (± 1) days of 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 5(± 1) days of treatment |
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |