Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief o… (NCT01393561) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
167 participantsStarted 2014-07
Plain-language summary
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.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Patients over 12 years old, of both sexes, remaining the feasibility of a legal representant according to need, able to understand and provide ICF and able to allow compliance to treatment and the requirements of the protocol, according to age group;
✓. Patients with symptoms of acute inflammation upper airway, starting between 24 and 48 hours of their inclusion in this study protocol;
✓. Presence of runny nose classification moderate or severe (score 2 or 3), according the responsible evaluation,
✓. Presence of nasal congestion classification moderate or severe (score 2 or 3), according the responsible evaluation.
Exclusion criteria
✕. Patients under 12 years old or weight less than 40kg;
✕. History of nasal obstruction in chronic rhinosinusitis and / or nasal polyposis;
✕. Oral chronic respirator with history for six months;
✕. Personal history of nasal surgery that in the opinion of the investigator can influence the resistance to nasal airflow;
✕. Patients who have a clinical history confirmed (diagnosed) with asthma;
✕. Patients under medicine treatment for chronic allergy;
✕. Patients with gastroesophageal reflux disease;
✕
What they're measuring
1
Improvement of nasal congestion and runny nose, after 48 hours of treatment
Timeframe: 48 hours after single dose of double-blind treatment