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

January 12, 2017 updated by: Ache Laboratorios Farmaceuticos S.A.

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

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.

Study Overview

Detailed Description

This study evaluate the efficacy and safety of experimental drug The study was designed to evaluate the efficacy and safety of fixed combinations Decongex® Plus Syrup and Decongex® Plus Oral Solution (consisting of brompheniramine maleate and phenylephrine hydrochloride) compared to Resfenol® Oral Solution (paracetamol, maleate chlorpheniramine and phenylephrine hydrochloride) in the treatment of nasal congestion and rhinorrhea present in acute attacks of viral rhinitis (common cold) and allergic. This study population will consist in participants of both sexes, aged between 6 to 11 years old with acute inflammatory condition of the upper airways, defined as nasal congestion and runny nose, with no less than 24 (twenty four) hours and a maximum of 48 (forty-eight) hours prior to inclusion.

Study Type

Interventional

Enrollment (Actual)

879

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • São Paulo
      • Guarulhos, São Paulo, Brazil
        • Ache Laboratorios Farmaceuticos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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;
  2. Patients with symptoms of acute inflammation upper airway, starting between 24 and 48 hours of their inclusion in this study protocol;
  3. Presence of runny nose classification moderate or severe (score 2 or 3), according the responsible evaluation;
  4. Presence of nasal congestion classification moderate or severe (score 2 or 3), according the responsible evaluation.

Exclusion Criteria:

  1. Patients younger than 2 years or percentile for body weight and/or height less than 25;
  2. History of nasal obstruction in chronic rhinosinusitis and / or nasal polyposis;
  3. Oral chronic respirator with history for six months;
  4. Personal history of nasal surgery that in the opinion of the investigator can influence the resistance to nasal airflow;
  5. Patients who have a clinical history confirmed (diagnosed) with asthma;
  6. Patients under medicine treatment for chronic allergy;
  7. Patients with gastroesophageal reflux disease;
  8. Presence of psychiatric illness of any kind;
  9. Presence of mental retardation from any cause;
  10. Diagnosis of renal or hepatic failure;
  11. Patients with genetic syndromes;
  12. History of hypersensitivity to (s) drug (s) of study or their excipients;
  13. Use of prohibited medicine within the prescribed period before the V0 - Inclusion Visit (Table 1);
  14. Patients who participated in the last 12 months, of clinical trials protocols;
  15. Patients who didn´t updated vaccine book;
  16. Relatives of sponsor´s or study site´s employee;
  17. Suggestive signs of bacterial infection of upper airways at rhinoscopy, otoscopy or oroscopy;
  18. Presence of anemic/inflamed turbinate at anterior rhinoscopy;
  19. Presence of septal deviation grade II and III (in any region and any nasal cavity) and / or nasal polyps, or other conditions determinants of nasal obstruction;
  20. Presence of purulent or mucopurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;
  21. Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the patient participation;
  22. Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the patient or interfere with the endpoints of study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: brompheniramine + phenylephrine
Fixed dose combination of 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 Names:
  • Group 1
Active Comparator: brompheniramine + pseudoephedrine
Fixed dose combination of brompheniramine + pseudoephedrine
Elixir: Brompheniramine (0,2mg/mL) and pseudoephedrine (3,0 mg/mL), t.i.d., according weight of patient
Other Names:
  • Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

48 hours after single dose of double-blind treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 2 and 5 (± 1) days of treatment
Clinical score of upper airway compromise
Time Frame: After 2 and 5 (± 1) days of treatment
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
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
Will be evaluated during the 5(± 1) days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fábio M Castro, IMA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 27, 2010

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimate)

July 13, 2011

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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