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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01393548
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.

Tracking Information
First Submitted Date  ICMJE October 27, 2010
First Posted Date  ICMJE July 13, 2011
Last Update Posted Date January 13, 2017
Study Start Date  ICMJE August 2014
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01393548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nasal Congestion and Inflammations
  • Rhinitis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: brompheniramine + phenylephrine
    Fixed dose combination of brompheniramine + phenylephrine
    Intervention: Drug: brompheniramine + phenylephrine
  • Active Comparator: brompheniramine + pseudoephedrine
    Fixed dose combination of brompheniramine + pseudoephedrine
    Intervention: Drug: Brompheniramine + pseudoephedrine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2016)
879
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2011)
538
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01393548
Other Study ID Numbers  ICMJE ACH-DCN-03(03/10)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ache Laboratorios Farmaceuticos S.A.
Study Sponsor  ICMJE Ache Laboratorios Farmaceuticos S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fábio M Castro IMA
PRS Account Ache Laboratorios Farmaceuticos S.A.
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP