Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
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|ClinicalTrials.gov Identifier: NCT01393548|
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : January 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nasal Congestion and Inflammations Rhinitis||Drug: brompheniramine + phenylephrine Drug: Brompheniramine + pseudoephedrine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||879 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Phase III, Randomized, Open, Parallel, Comparative to Evaluate the Efficacy and Safety of the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis and Allergic Reactions, in Pediatric Patients|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||December 2016|
Experimental: brompheniramine + phenylephrine
Fixed dose combination of brompheniramine + phenylephrine
Drug: brompheniramine + phenylephrine
Oral solution: brompheniramine (2mg/mL) and phenylephrine (2,5 mg/mL), t.i.d., according weight of patient.
OR Syrup: brompheniramine (2mg/5mL) and phenylephrine(5 mg/5mL), t.i.d., according weight of patient.
Other Name: Group 1
Active Comparator: brompheniramine + pseudoephedrine
Fixed dose combination of brompheniramine + pseudoephedrine
Drug: Brompheniramine + pseudoephedrine
Elixir: Brompheniramine (0,2mg/mL) and pseudoephedrine (3,0 mg/mL), t.i.d., according weight of patient
Other Name: Group 2
- Improvement of nasal congestion and runny nose, after 48 hours of treatment [ Time Frame: 48 hours after single dose of double-blind 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.
- Overall score of nasal and extranasal symptoms (nasal congestion, runny nose, sneezing, watery eyes and itching) [ Time Frame: After 2 and 5 (± 1) days of treatment ]
- Clinical score of upper airway compromise [ Time Frame: After 2 and 5 (± 1) days of treatment ]
- Proportion of subjects who used at least once the rescue medication [ Time Frame: 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. [ Time Frame: Will be evaluated during the 5(± 1) days of treatment ]Collection of safety data throughout the whole study period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393548
|Ache Laboratorios Farmaceuticos|
|Guarulhos, São Paulo, Brazil|
|Principal Investigator:||Fábio M Castro||IMA|