Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
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|ClinicalTrials.gov Identifier: NCT01393561|
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : October 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Nasal Congestion and Inflammations Rhinitis||Drug: Group 1 Drug: Group 2||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||167 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multicenter Clinical Trial, Phase III, Randomized, Double-blind, Placebo Controlled, Comparative for Evaluate the Efficacy and Safety of Fixed Dose Combination of Brompheniramine Maleate + Phenylephrine Chlorhydrate for the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis (Common Cold) and Allergic Reactions, in Patients Over 12 Years Old|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Group 1
Fixed dose combination of brompheniramine + phenylephrine.
Drug: Group 1
Brompheniramine + phenylephrine
Placebo Comparator: Group 2
Drug: 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): NCT01393561
|Principal Investigator:||Fábio M Castro||IMA|