Clinical trial NCT01177852: 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
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Inflammation
Cough
Rhinitis
Keywords: cough, acute rhinitis, common cold, nasal symptoms, children.
Acute inflammation upper airway
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2010-08-09
Enrollment: 0
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: 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.


Eligibility 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.

Primary outcomes:
measure: Improvement of nasal congestion and cough
timeFrame: Evaluated on the day 2 after beginning treatment
Secondary outcomes:
measure: Improvement of nasal congestion and cough
timeFrame: Evaluated on the 7(±1) day after beginning treatment
measure: Improvement of non-obstructive nasal symptoms
timeFrame: Evaluated on the day 2 and 7 (±1) after beginning treatment
measure: Reduction of the frequency of nighttime awakenings of parent/guardian/roommate of the child
timeFrame: Evaluated on the day 2 and 7 (±1) after beginning treatment
measure: Reduction of vomiting frequency episodes triggered by coughing
timeFrame: Evaluated on the day 2 and 7 (±1) after beginning treatment
measure: Improvement of acute rhinitis signs
timeFrame: Evaluated on the day 2 and 7 (±1) after beginning treatment
measure: Use of rescue medication
timeFrame: Evaluated on the day 2 and 7 (±1) after beginning treatment
measure: Overall impression of improvement by the investigator
timeFrame: Evaluated on the day 2 and 7 (±1) after beginning treatment
measure: Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
timeFrame: Will be evaluated during the 7(± 1) days of treatment
Other outcomes:
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