- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01393548
Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
São Paulo
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Guarulhos, São Paulo, Brazil
- Ache Laboratorios Farmaceuticos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: brompheniramine + phenylephrine
Fixed dose combination of 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 Names:
|
Active Comparator: brompheniramine + pseudoephedrine
Fixed dose combination of brompheniramine + pseudoephedrine
|
Elixir: Brompheniramine (0,2mg/mL) and pseudoephedrine (3,0 mg/mL), t.i.d., according weight of patient
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
48 hours after single dose of double-blind treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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After 2 and 5 (± 1) days of treatment
|
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Clinical score of upper airway compromise
Time Frame: After 2 and 5 (± 1) days of treatment
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After 2 and 5 (± 1) days of treatment
|
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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
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Within 2 days and the period of 5 (± 1) days of treatment
|
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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
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Collection of safety data throughout the whole study period
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Will be evaluated during the 5(± 1) days of treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fábio M Castro, IMA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Nose Diseases
- Inflammation
- Rhinitis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Ephedrine
- Pseudoephedrine
- Phenylephrine
- Oxymetazoline
- Brompheniramine
Other Study ID Numbers
- ACH-DCN-03(03/10)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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