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

Primary Purpose

Nasal Congestion and Inflammations, Rhinitis

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

brompheniramine + phenylephrine

Brompheniramine + pseudoephedrine

About this trial

This is an interventional treatment trial for Nasal Congestion and Inflammations focused on measuring Rhinitis, common cold, nasal symptoms, children

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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;
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;
Use of prohibited medicine within the prescribed period before the V0 - Inclusion Visit (Table 1);
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;
Suggestive signs of bacterial infection of upper airways at rhinoscopy, otoscopy or oroscopy;
Presence of anemic/inflamed turbinate at anterior rhinoscopy;
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;
Presence of purulent or mucopurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;
Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the patient participation;
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.

Sites / Locations

Ache Laboratorios Farmaceuticos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

brompheniramine + phenylephrine

brompheniramine + pseudoephedrine

Arm Description

Fixed dose combination of brompheniramine + phenylephrine

Fixed dose combination of brompheniramine + pseudoephedrine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Clinical score of upper airway compromise

Proportion of subjects who used at least once the rescue medication

Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.

Collection of safety data throughout the whole study period

Full Information

NCT ID

NCT01393548

First Posted

October 27, 2010

Last Updated

January 12, 2017

Sponsor

Ache Laboratorios Farmaceuticos S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01393548

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ache Laboratorios Farmaceuticos S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasal Congestion and Inflammations, Rhinitis

Keywords

Rhinitis, common cold, nasal symptoms, children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

879 (Actual)

8. Arms, Groups, and Interventions

Arm Title

brompheniramine + phenylephrine

Arm Type

Experimental

Arm Description

Fixed dose combination of brompheniramine + phenylephrine

Arm Title

brompheniramine + pseudoephedrine

Arm Type

Active Comparator

Arm Description

Fixed dose combination of brompheniramine + pseudoephedrine

Intervention Type

Drug

Intervention Name(s)

brompheniramine + phenylephrine

Other Intervention Name(s)

Group 1

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Brompheniramine + pseudoephedrine

Other Intervention Name(s)

Group 2

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

48 hours after single dose of double-blind treatment

Secondary Outcome Measure Information:

Title

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

Title

Clinical score of upper airway compromise

Time Frame

After 2 and 5 (± 1) days of treatment

Title

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

Title

Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.

Description

Collection of safety data throughout the whole study period

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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; 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; Use of prohibited medicine within the prescribed period before the V0 - Inclusion Visit (Table 1); 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; Suggestive signs of bacterial infection of upper airways at rhinoscopy, otoscopy or oroscopy; Presence of anemic/inflamed turbinate at anterior rhinoscopy; 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; Presence of purulent or mucopurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule; Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the patient participation; 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fábio M Castro

Organizational Affiliation

IMA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ache Laboratorios Farmaceuticos

City

Guarulhos

State/Province

São Paulo

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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