Epinastine + Pseudoephedrine SR (Slow Release) Versus Epinastine Alone in Patients With Perennial Allergic Rhinitis

NCT02182518 | Completed Phase 3

• 1 other identifier: 262.254
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this trial is to evaluate the clinical efficacy and safety of Epinastine 10 mg + Pseudoephedrine 120 mg slow release (SR) administered twice a day, compared to Epinastine 10 mg alone administered twice daily.

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (4)

• Classification of severity of nasal blockage by Visual Analog Scale (VAS)

  at the end of weeks 1, 2, 3, 4

• Incidence of laboratory alterations

  day 14, 28 and 35

• Incidence of premature discontinuations of the study due to adverse events

  up to 4 weeks

• Incidence and severity of all adverse events

  up to 5 weeks

Secondary Outcomes (11)

• Daily evaluation of the nasal blockage by the patient

  daily up to 4 weeks

• Classification of the severity of the symptoms by the investigator

  at the end of weeks 1, 2, 3, 4

• Changes in nasal physical examination

  Baseline and at the end of weeks 1, 2, 3, 4

• Changes in rhinorrhea symptoms evaluated by investigator

  Baseline and at the end of weeks 1, 2, 3, 4

• Changes in pruritus symptoms evaluated by investigator

  Baseline and at the end of weeks 1, 2, 3, 4

Study Arms (2)

Epinastine + Pseudoephedrine

EXPERIMENTAL

Drug: Epinastine; Drug: Pseudoephedrine; Drug: Placebo

Epinastine

EXPERIMENTAL

Drug: Epinastine; Drug: Placebo

Interventions

Epinastine DRUG

Epinastine; Epinastine + Pseudoephedrine

Pseudoephedrine DRUG

Epinastine + Pseudoephedrine

Placebo DRUG

Placebo during run-in period

Epinastine; Epinastine + Pseudoephedrine

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:

• Male and female outpatients
• Over 12 years old
• Patients who have granted their written informed consent, personally or by a legal representative, to be part of the study and in accomplishment of the model of informed consent approved by the Ethic Committee of the institution
• Patients with an established diagnosis of allergic perennial rhinitis under the clinical criteria (allergic to one or more allergens)
• Patients with moderate or complete nasal blockage characterizes by ≥50 mm in the VAS for this parameter during visits 1 and 2
• Patients with positive (≥3 mm compared to the negative control) skin test ("Prick Test") to one or more of the following allergens:
• Dermatophagoides pteronyssinus
• Dermatophagoides farinae
• Blomia tropicalis
• Alternaria alternata
• Cladosporium herbarum
• Aspergillus fumigatus
• Penicillium notatum
• cat's fur
• dog's fur

You may not qualify if:

• Pregnant or breast feeding women, or women without contraceptive method who:
• are not in the postmenopausal period and/or
• have not been submitted to bilateral tubal ligation or hysterectomy and/or
• are not under one of the following contraceptive control:
• oral contraceptive
• IUD (intrauterine device)
• diaphragm
• Patients unable to understand, accept or follow the protocol instructions
• History of serious adverse events with antihistamines
• Patients under treatment with calcium antagonists or other antihypertensive drugs
• Patients under treatment with digitalis
• Patients under treatment with MAO (monoamine oxidase) inhibitors
• Patients under treatment with sympathicomimetics
• Patients that have received any of the following drugs during the periods specified below, before visit 1:
• Inhaled/Topics

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

epinastine; Pseudoephedrine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2000
• Primary Completion: July 1, 2001
• Last Updated: July 14, 2014

Record last verified: 2014-07