Study Comparing 3 Formulations to Evaluate the Efficacy and Safety of the Inflammatory Symptoms of the Upper Respiratory Tract, in Children Between 2 and 6 Years Old

A Double Blind, Randomized, Multicenter Phase III Study Comparing 3 Formulations: Dose Fixed Combination of Bronpheniramine and Fenilefrine, Bronpheniramine Isolated and Fenilefrine Isolated, to Evaluate the Efficacy and Safety of the Treatment of the Inflammatory Symptoms of Upper Respiratory Tract, in Children Between 2 and 6 Years Old.

The primary outcome of this study is to evaluate the clinical efficacy of the dose fixed combination and each drug, that composes it, isolated, regarding the respiratory symptoms improvement in superior air passages acute affection in children between 2 and 6 years old.

Study Overview

• Status: Withdrawn
• Conditions: Common Cold
• Intervention / Treatment: Drug: Bronpheniramine and fenilefrine (Decongex Plus); Drug: Bronpheniramine isolated; Drug: Fenilefrine isolated

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • UNIFESP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients between 2 and 6 years old, according to dosage information provided in the product package insert.
2. Patient with a relative available for observation of symptoms during the night.
3. Patients with acute symptoms of air passages jeopardizing, initiated, at least, 24 hours before patient inclusion in this protocol and, at most, in the 3 days before patient inclusion.
4. Patients facing at least a 7 points score in the addition of general symptoms (rhinorrhea, sneeze, itching, nose obstruction and coughing).
5. At least two symptoms must be moderated in scale, for specific evaluation.
6. Presence of fluid and/or sputum verified through a rhinoscopy.

Exclusion Criteria:

1. Children younger than 2 years old or a weight and/or height percentual inferior to 10.
2. Children with corporal weight superior to 30Kg.
3. Suggestive signs of superior air passages bacterial infection to the rhinoscopy, otoscopy and oropharingoscopy.
4. Chronic oral breath with a 6 months history.
5. Presence of degree II and III of nasal septal deviation (in any region and in any nasal fossa) and/or presence of nasal polyp or other conditions that determine nasal obstruction.
6. Patients in a chronic medication treatment for allergy.
7. Patients with an asthma clinical history confirmed (diagnosed).
8. Personal preceding of nasal surgery that in the opinion of the investigator can influence in the resistance to the air nose flow.
9. Children older than 5 years old that are not registered in the school.
10. Children that don´t have vaccination notebook.
11. Patient that had used prohibited medication, during the established period before V0 - Randomization Visit (See Picture 1).
12. Hypersensitive history to the study drug or its components.
13. Patient that have participated in, during the last 12 months, study protocols (according to Resolution 251, dated of August, 7th 1997, item III, sub-item J, "Investigator Responsibility", its recommended that the same person does not be subject of a clinical study in a new project before have elapsed 1(one) year from previous study participation, unless there is a direct benefit to the study patient).
14. Relatives of sponsor´s or study site´s employee.
15. Patients with gastroesofagic reflux disease.
16. Presence of psychiatry diseases.
17. Presence of mental disorder of any etiology.
18. Renal and hepatic insufficiency.
19. Patient with current evidence of clinically significant diseases, of origin: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrinological, psychiatric, self immune, pulmonary, or other that preclude, according to the investigator criteria, the subject participation.
20. Patients with genetic diseases.
21. Any finding of clinical observation (anamneses and physical evaluation) that be understood by the investigator as risk to the patient participation in the study.
22. Any finding of lab result that the investigator judges as a risk to the patient, considering the participation in the study.
23. Patients with AST and ALT levels higher than 20% related to the upper normal limits; total bilirubins with an increase of 10% related to the upper normal limits; fasting serum/blood glucose >99mg/dl or postprandial serum/blood glucose >140mg/dl; Hb <10g/dl ou Hb >15 g/dl; serum creatinine with levels over than 10% of upper limit; serum potassium under 3,5 mEq/L, or upper 5,1 mEq/L; serum sodium under 136 mEq/L, or upper 145 mEq/L.
24. Presence of hematogenous or meliceric, purulent or mucus purulent secretion, bulging or malformation (leporine lips and nasolabial fissure surgically corrected or not) in the region of the nasal vestibule.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decongex Plus	Drug: Bronpheniramine and fenilefrine (Decongex Plus); Oral Solution: Bronpheniramine (2mg/ml) and fenilefrine (2,5mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.
Active Comparator: Bronpheniramine isolated	Drug: Bronpheniramine isolated; Oral Solution: Bronpheniramine (2mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.
Active Comparator: Fenilefrine isolated	Drug: Fenilefrine isolated; Oral Solution: Fenilefrine (2,5mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the clinical efficacy of the dose fixed combination and each drug, that compose it, isolated, regarding the respiratory symptoms improvement in superior air passages acute affection in children between 2 and 6 years old.	04/2010

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient adherence to the treatment.	04/2010
Use of co intervention for symptom relief during treatment	Assessed during the treatment in the diary and questioned by the Investigator at the visits
Evaluate the intensity of the symptoms during the treatment	Assessed during the treatment
Adverse effect appearance during the study and tolerability	Assessed during the treatment and at the final visit

Collaborators and Investigators

• Sponsor: Ache Laboratorios Farmaceuticos S.A.
• Investigators: Principal Investigator: Luc Weckx, MD, Federal University of São Paulo; Principal Investigator: Fabio Castro, MD, Instituto de Medicina Avancada; Principal Investigator: Flavio Sano, MD, Hospital Beneficência Nipo Brasileiro

Study record dates

Study Registration Dates

• First Submitted: August 26, 2009
• First Submitted That Met QC Criteria: August 27, 2009
• First Posted (Estimate): August 28, 2009

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: treatment; common cold; inflammatory symptoms of superior air passages affection
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: ACH-DCN-03(05/08)