Clinical trial NCT01393548: Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasal Congestion and Inflammations
Rhinitis
Keywords: Rhinitis
common cold
nasal symptoms
children
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 879
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Improvement of nasal congestion and runny nose, after 48 hours of treatment
timeFrame: 48 hours after single dose of double-blind treatment
Secondary outcomes:
measure: Overall score of nasal and extranasal symptoms (nasal congestion, runny nose, sneezing, watery eyes and itching)
timeFrame: After 2 and 5 (± 1) days of treatment
measure: Clinical score of upper airway compromise
timeFrame: After 2 and 5 (± 1) days of treatment
measure: Proportion of subjects who used at least once the rescue medication
timeFrame: Within 2 days and the period of 5 (± 1) days of treatment
measure: Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
timeFrame: Will be evaluated during the 5(± 1) days of treatment
Other outcomes:
Locations:
city: Guarulhos
country: Brazil
facility: Ache Laboratorios Farmaceuticos
state: São Paulo
Study officials:
affiliation: IMA
name: Fábio M Castro
role: PRINCIPAL_INVESTIGATOR
References: