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

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Inflammation; Cough; Rhinitis
• Intervention / Treatment: Drug: diphenhydramine + dropropizine + pseudoephedrine; Drug: Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of nasal congestion and cough	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.	Evaluated on the day 2 after beginning treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of nasal congestion and cough	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.	Evaluated on the 7(±1) day after beginning treatment
Improvement of non-obstructive nasal symptoms	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.	Evaluated on the day 2 and 7 (±1) after beginning treatment
Reduction of the frequency of nighttime awakenings of parent/guardian/roommate of the child		Evaluated on the day 2 and 7 (±1) after beginning treatment
Reduction of vomiting frequency episodes triggered by coughing		Evaluated on the day 2 and 7 (±1) after beginning treatment
Improvement of acute rhinitis signs	Assessed by anterior rhinoscopy and application of specific clinical scores	Evaluated on the day 2 and 7 (±1) after beginning treatment
Use of rescue medication		Evaluated on the day 2 and 7 (±1) after beginning treatment
Overall impression of improvement by the investigator	Specific scale and overall impression of improvement by a parent/guardian/ caregiver of the child	Evaluated on the day 2 and 7 (±1) after beginning treatment
Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.	Collection of safety data throughout the whole study period	Will be evaluated during the 7(± 1) days of treatment

Collaborators and Investigators

• Sponsor: Ache Laboratorios Farmaceuticos S.A.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: August 6, 2010
• First Submitted That Met QC Criteria: August 6, 2010
• First Posted (Estimate): August 9, 2010

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: cough, acute rhinitis, common cold, nasal symptoms, children.; Acute inflammation upper airway
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Picornaviridae Infections; Signs and Symptoms, Respiratory; Nose Diseases; Inflammation; Rhinitis; Cough; Common Cold; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Hypnotics and Sedatives; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Central Nervous System Stimulants; Antitussive Agents; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Diphenhydramine; Promethazine; Ephedrine; Pseudoephedrine; Brompheniramine; Brompheniramine, pseudoephedrine drug combination; Dipropizine
• Other Study ID Numbers: ACH-NTS-03(02/10)