Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
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ClinicalTrials.gov Identifier: NCT01393548 |
Recruitment Status :
Completed
First Posted : July 13, 2011
Last Update Posted : January 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nasal Congestion and Inflammations Rhinitis | Drug: brompheniramine + phenylephrine Drug: Brompheniramine + pseudoephedrine | Phase 3 |
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 |

Arm | Intervention/treatment |
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Experimental: brompheniramine + phenylephrine
Fixed dose combination of brompheniramine + phenylephrine
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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 |
- 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.
- 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 ]
- Clinical score of upper airway compromise [ Time Frame: 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 ]
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393548
Brazil | |
Ache Laboratorios Farmaceuticos | |
Guarulhos, São Paulo, Brazil |
Principal Investigator: | Fábio M Castro | IMA |
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 Key Record Dates |
Last Update Posted: | January 13, 2017 |
Last Verified: | January 2017 |
Rhinitis common cold nasal symptoms children |
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 |