CompletedPhase 3

Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis

Brazil879 participantsStarted 2014-08

Plain-language summary

This is a multicenter clinical trial, phase III, non-inferiority, controlled by active medicine, open, randomized, enroll 538 children, 2 to 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 range2 Years – 12 Years

SexALL

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Inclusion criteria

✓. Patients between 2 and 12 years old, of both sexes. Must be responsible be able to understand and provide ICF and able to allow compliance to treatment and protocol requirements, fulfilling the regular visits;
✓. 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 younger than 2 years or percentile for body weight and/or height less than 25;
✕. 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;
✕. Presence of psychiatric illness of any kind;

What they're measuring

Improvement of nasal congestion and runny nose, after 48 hours of treatment

Timeframe: 48 hours after single dose of double-blind treatment

Trial details

NCT IDNCT01393548

SponsorAche Laboratorios Farmaceuticos S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11

View on ClinicalTrials.gov More Nasal Congestion and Inflammations trials