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

NCT01393561 | Completed Phase 3

• 1 other identifier: ACH-DCN-03(04/10)
• Study Type: interventional
• Target: 167
• Locations: 0 countries
• Sites: N/A

Brief 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.

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)

Group 1

EXPERIMENTAL

Fixed dose combination of brompheniramine + phenylephrine.

Drug: Group 1

Group 2

PLACEBO COMPARATOR

Placebo

Drug: Group 2

Interventions

Group 1 DRUG

Brompheniramine + phenylephrine

Group 1

Group 2 DRUG

Placebo

Group 2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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 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;
• 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, according to age group;
• Relatives of sponsor´s or study site´s employee;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Nasal Obstruction; Inflammation; Rhinitis; Common Cold

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

Study Officials

• Fábio M Castro

  IMA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 31, 2016

Record last verified: 2016-10