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

NCT01393548 | Completed Phase 3

• 1 other identifier: ACH-DCN-03(03/10)
• Study Type: interventional
• Target: 879
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasal Congestion and Inflammations; Rhinitis

Keywords

Rhinitis; common cold; nasal symptoms; children

Outcome Measures

Primary Outcomes (1)

• Improvement of nasal congestion and runny nose, after 48 hours of 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.

  48 hours after single dose of double-blind treatment

Secondary Outcomes (4)

• Overall score of nasal and extranasal symptoms (nasal congestion, runny nose, sneezing, watery eyes and itching)

  After 2 and 5 (± 1) days of treatment

• Clinical score of upper airway compromise

  After 2 and 5 (± 1) days of treatment

• Proportion of subjects who used at least once the rescue medication

  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.

  Will be evaluated during the 5(± 1) days of treatment

Study Arms (2)

brompheniramine + phenylephrine

EXPERIMENTAL

Fixed dose combination of brompheniramine + phenylephrine

Drug: brompheniramine + phenylephrine

brompheniramine + pseudoephedrine

ACTIVE COMPARATOR

Fixed dose combination of brompheniramine + pseudoephedrine

Drug: Brompheniramine + pseudoephedrine

Interventions

brompheniramine + phenylephrine DRUG

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.

Also known as: Group 1

brompheniramine + phenylephrine

Brompheniramine + pseudoephedrine DRUG

Elixir: Brompheniramine (0,2mg/mL) and pseudoephedrine (3,0 mg/mL), t.i.d., according weight of patient

Also known as: Group 2

brompheniramine + pseudoephedrine

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• Presence of mental retardation from any cause;
• Diagnosis of renal or hepatic failure;
• Patients with genetic syndromes;
• History of hypersensitivity to (s) drug (s) of study or their excipients;
• Patients who participated in the last 12 months, of clinical trials protocols;
• Patients who didn´t updated vaccine book;
• Relatives of sponsor´s or study site´s employee;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (1)

Ache Laboratorios Farmaceuticos

Guarulhos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Nasal Obstruction; Inflammation; Rhinitis; Common Cold

Interventions

brompheniramine, pseudoephedrine drug combination; Acetylcysteine

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Fábio M Castro

  IMA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: July 13, 2011
• Study Start: August 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

BR (1)