Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms, Suffering From Non-productive Cough and Acute Rhinitis

NCT01199497 | Withdrawn Phase 3

• 1 other identifier: ACH-NTS-03(08/10)
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multicenter clinical trial, phase III, controlled by active medicine, double-blind, randomized, enroll 208 subjects, above 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.

Conditions

Nasal Congestion; Cough

Keywords

cough, acute rhinitis, nasal congestion, common cold, nasal symptoms, children.; Nasal congestion and non-productive cough, with or without associate other nasal and extranasal symptoms.

Outcome Measures

Primary Outcomes (1)

• Primary efficacy criteria

  The changes of lung function parameter: pre-bronchodilator forced expiratory volume in first second (FEV1) including baseline and 24th week.

  baseline and week 24

Secondary Outcomes (1)

• Secondary efficacy criteria

  baseline, week 8, 16 and 24

Study Arms (2)

Group 1

EXPERIMENTAL

Fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).

Drug: Group 1

Group 2

PLACEBO COMPARATOR

Placebo

Drug: Group 2

Interventions

Group 1 DRUG

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

Group 1

Group 2 DRUG

placebo

Group 2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 12 years old, of both sexes;
• Clinical condition compatible with acute rhinitis accompanied by nasal congestion;
• Non-productive cough, daytime and/or nighttime with at least 3 and up 5 consecutive days in duration;
• Score greater than or equal to 3 points on the cough severity score (As per item 4.1.2);
• Score greater than or equal to 2 points on the nasal congestion severity score (As per item 4.1.3);
• If necessary, ICF signed by a parent/representant, or in case the patient over 18 years old, his own signature;
• Patient and/or representant capacity, according to investigator evaluation, for compliance at the treatment and protocol requirements, fulfilling the regular visits;

You may not qualify if:

• Non-productive cough with purulent smear, fever (axilar 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;
• Septal deviation level III (in any region and any nasal cavity) and/or nasal polyps or other determinants conditions of nasal congestion;
• Previous diagnosis of asthma;
• Female patients with positive b-HCG;
• Patients under treatment for chronic allergy;
• Presence of purulent or mucupurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;
• Current use of systemic antibiotics for any reason;
• Use of prohibited medicine within the prescribed period before V0 as shown in item 9.3 of this protocol;
• Participation in last one year of clinical protocols;
• Any psychiatric diseases, including major depression;
• Presence of mental retardation from any cause;
• Diagnosis of renal or hepatic failure;
• History of hypersensitivity to any component of the study drugs;
• Relatives of sponsor´s or study site´s employee;
• Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the patient participation;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Nasal Obstruction; Cough; Common Cold

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: January 1, 2013
• Last Updated: July 13, 2017

Record last verified: 2017-07