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

NCT ID: NCT01393561

Last Updated: 2016-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-12-31

Brief Summary

This is a multicenter clinical trial, phase III, superiority, controlled by active medicine, double-blind, randomized, enroll 166 children, over 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.

Conditions

Nasal Congestion and Inflammations; Rhinitis

Keywords

Rhinitis; Common cold; Nasal symptoms; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

Fixed dose combination of brompheniramine + phenylephrine.

Group Type: EXPERIMENTAL

Group 1

Intervention Type: DRUG

Brompheniramine + phenylephrine

Group 2

Placebo

Group Type: PLACEBO_COMPARATOR

Group 2

Intervention Type: DRUG

Placebo

Interventions

Group 1

Brompheniramine + phenylephrine

Intervention Type: DRUG

Group 2

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients over 12 years old, of both sexes, remaining the feasibility of a legal representant according to need, able to understand and provide ICF and able to allow compliance to treatment and the requirements of the protocol, according to age group;

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 under 12 years old or weight less than 40kg;

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, according to age group;

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fábio M Castro

Role: PRINCIPAL_INVESTIGATOR

IMA

Other Identifiers

ACH-DCN-03(04/10)

Identifier Type: -

Identifier Source: org_study_id