Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Ache Laboratorios Farmaceuticos S.A..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:
NCT01177852
First received: August 6, 2010
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

Multicenter clinical trial, phase III, controlled by active medicine, open, randomized, enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.


Condition Intervention Phase
Inflammation
Cough
Rhinitis
Drug: diphenhydramine + dropropizine + pseudoephedrine
Drug: Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Clinical Trial, Phase III, Controlled, Open, Parallel Group, Randomized, Comparing the Fixed Dose Combination of Diphenhydramine + Dropropizine + Pseudoephedrine and the Combined Use of Dropropizine and Fixed Dose Combination of Pseudoephedrine Hydrochloride + Brompheniramine Maleate Used Orally for Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2 to 12 Years Old, Suffering From Non-productive Cough and Acute Rhinitis.

Resource links provided by NLM:


Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:
  • Improvement of nasal congestion and cough [ Time Frame: Evaluated on the day 2 after beginning treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (by a parent/guardian/caregivers) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.


Secondary Outcome Measures:
  • Improvement of nasal congestion and cough [ Time Frame: Evaluated on the 7(±1) day after beginning treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (by a parent/guardian/caregivers) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.

  • Improvement of non-obstructive nasal symptoms [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]
    Participants were evaluated (by a parent/guardian/caregivers for pain intensity by using a sum of 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.

  • Reduction of the frequency of nighttime awakenings of parent/guardian/roommate of the child [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]
  • Reduction of vomiting frequency episodes triggered by coughing [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]
  • Improvement of acute rhinitis signs [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]
    Assessed by anterior rhinoscopy and application of specific clinical scores

  • Use of rescue medication [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]
  • Overall impression of improvement by the investigator [ Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment ] [ Designated as safety issue: No ]
    Specific scale and overall impression of improvement by a parent/guardian/ caregiver of the child

  • Safety descriptive about occurence of adverse events, evaluation of results of general physical examination. [ Time Frame: Will be evaluated during the 7(± 1) days of treatment ] [ Designated as safety issue: Yes ]
    Collection of safety data throughout the whole study period


Estimated Enrollment: 962
Study Start Date: October 2011
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Notuss® syrup
Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).
Drug: diphenhydramine + dropropizine + pseudoephedrine

Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).

Posology: The medicine treat will be as follows:

- Notuss® syrup Age: 2-5 years / Dosage: 5,0 mL Age: 6-12 years / Dosage: 10,0 ml

Active Comparator: Dropropizine + Pseudoephedrine and brompheniramine
Group 2: combined use of dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate.
Drug: Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).

Dropropizine:

Age: 2 - 3 years / Dosage: 5,0 ml Age: 4 - 12 years / Dosage: 10,0 ml

Pseudoephedrine hydrochloride + brompheniramine maleate:

Age: 2 - 3 years / Dosage: 2,5 ml Age: 4 - 6 years / Dosage: 5,0 ml Age: 7 - 9 years / Dosage: 7,5 ml Age: 10 - 12 years / Dosage: 10,0 ml


  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients between 2 and 12 years old, of both sexes;
  2. Clinical condition compatible with acute rhinitis accompanied by nasal obstruction;
  3. Non-productive cough, daytime and/or nighttime with at least 3 and up 5 consecutive days in duration;
  4. Score greater than or equal to 3 points on the cough severity score (As per item 4.1.2);
  5. Score greater than or equal to 2 points on the nasal obstruction severity score (As per item 4.1.3);
  6. ICF signed by a parent/caregiver/representant;
  7. Parent/Caregiver/Representant capacity, according to investigator evaluation, for compliance at the treatment and protocol requirements, fulfilling the regular visits;

Exclusion Criteria:

  1. Non-productive cough with purulent smear, fever (axillar temperature superior than 37,8°C/100°F), purulent runny nose and other signs and symptoms of bacteria infection of upper and lower airways at 7 days before the screening/randomization visit;
  2. Septal deviation level III (in any region and any nasal cavity) and/or nasal polyps or other determinants conditions of nasal congestion;
  3. Previous diagnosis of asthma;
  4. Patients under treatment for chronic allergy;
  5. Presence of purulent or mucopurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;
  6. Current use of systemic antibiotics for any reason;
  7. Use of prohibited medicine within the prescribed period before V0 as shown in item 9.3 of this protocol;
  8. Participation in last one year of clinical protocols;
  9. Any psychiatric diseases, including major depression;
  10. Presence of mental retardation from any cause;
  11. Diagnosis of renal or hepatic failure;
  12. History of hypersensitivity to any component of the study drugs;
  13. Relatives of sponsor´s or study site´s employee;
  14. Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the patient participation;
  15. Patient or parent/caregiver/representant with a history of lack of compliance to treatment or previous treatment protocols;
  16. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Carla Rosana Goulart Silva Peron, MD, Ache Laboratorios Farmaceuticos S.A
ClinicalTrials.gov Identifier: NCT01177852     History of Changes
Other Study ID Numbers: ACH-NTS-03(02/10)
Study First Received: August 6, 2010
Last Updated: July 12, 2011
Health Authority: Brazil: ANVISA - Health Authority

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
cough, acute rhinitis, common cold, nasal symptoms, children.
Acute inflammation upper airway

Additional relevant MeSH terms:
Cough
Inflammation
Rhinitis
Common Cold
Pathologic Processes
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Maleic acid
Brompheniramine
Diphenhydramine
Promethazine
Ephedrine
Dipropizine
Pseudoephedrine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014