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

• ClinicalTrials.gov Identifier: NCT01393548
• Recruitment Status: Completed
• First Posted: July 13, 2011
• Last Update Posted: January 13, 2017
• Sponsor: Ache Laboratorios Farmaceuticos S.A.
• Information provided by (Responsible Party): Ache Laboratorios Farmaceuticos S.A.

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.

Condition or disease	Intervention/treatment	Phase
Nasal Congestion and Inflammations; Rhinitis	Drug: brompheniramine + phenylephrine; Drug: Brompheniramine + pseudoephedrine	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 879 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: August 2014
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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 ]
2. Clinical score of upper airway compromise [ Time Frame: After 2 and 5 (± 1) days of treatment ]
3. 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 ]
4. 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

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

Ache Laboratorios Farmaceuticos

Guarulhos, São Paulo, Brazil

Sponsors and Collaborators

Ache Laboratorios Farmaceuticos S.A.

Investigators

• Principal Investigator: Fábio M Castro; IMA

More Information

• Responsible Party: Ache Laboratorios Farmaceuticos S.A.
• ClinicalTrials.gov Identifier: NCT01393548
• Other Study ID Numbers: ACH-DCN-03(03/10)
• First Posted: July 13, 2011
• Last Update Posted: January 13, 2017
• Last Verified: January 2017

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:

Rhinitis; common cold; nasal symptoms; children

Additional relevant MeSH terms:

Rhinitis; Inflammation; Pathologic Processes; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Brompheniramine; Phenylephrine; Oxymetazoline; Pseudoephedrine; Ephedrine; Cardiotonic Agents; Mydriatics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Respiratory System Agents; Adrenergic alpha-1 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents; Bronchodilator Agents