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Multicenter clinical trial, phase III, controlled by active medicine, double-blind, randomized, enroll 208 subjects, above 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 |
|---|---|---|---|
| Group 1 | Experimental | Fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup). |
|
| Group 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 | Drug | fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy criteria | The changes of lung function parameter: pre-bronchodilator forced expiratory volume in first second (FEV1) including baseline and 24th week. | baseline and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy criteria | Changes in forced expiratory volume in first second (FEV1). | baseline, week 8, 16 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Group 2 | Drug | placebo |
|
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| D003371 | Cough |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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