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

Double-blind, Randomized, Parallel Trial to Evaluate the Clinical Efficacy and Safety of Epinastine 10 mg + Pseudoephedrine 120 mg SR, Twice a Day, Versus Epinastine 10 mg Alone, Twice a Day, in the Treatment of Outpatients With Perennial Allergic Rhinitis

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic, Perennial
• Intervention / Treatment: Drug: Epinastine; Drug: Pseudoephedrine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

    • short acting β2 agonists (12 hours)
    • long acting β2 agonists (48 hours)
    • ipratropium bromide (12 hours)
    • nasal drops without vasoconstrictors (3 days)
    • DSCG (disodium cromoglycate) (3 days)
    • nedocromil (7 days)
    • nasal drops with vasoconstrictors (7 days)
    • azelastine (14 days)
    • levocabastine (14 days)
    • corticosteroids (30 days)
    • corticosteroids on the site of Prick test (3 months)
    • other investigational drug (3 months)

  • Oral

    • short acting β2 agonists (18 hours)
    • short acting theophylline (24 hours)
    • phenothiazines (48 hours)
    • long acting theophylline (72 hours)
    • anticholinergics (7 days)
    • antihistamines (except astemizole) (7 days)
    • MAO (monoamine oxidase) inhibitors (14 days)
    • corticosteroids (30 days)
    • ketotifen (3 months)
    • imipramine (30 days)
    • astemizole (2 months)
    • other investigational drugs (3 months)

  • Parenteral

    • aminophylline (24 hours)
    • phenothiazines (48 hours)
    • antihistamines (7 days)
    • corticosteroids (30 days)
    • imipramine (30 days)
    • other investigational drugs (3 months)
• Patients under desensitization therapy
• Patients under therapy with antibiotics
• Patients with non compensate endocrine disease
• Patients with atrophic rhinitis
• Patients with rhinitis due to acetylsalicylic acid
• Patients with acute or chronic infectious sinusitis
• Patients with asthma, that need treatment with beta-2 agonists more than twice per week
• Patients with glaucoma
• Patients with history or renal and/or hepatic failure
• Patients with known platelets dysfunction due to any disease or to drugs (purpura thrombocytopenic idiopathic, use of anticoagulants, use of antiplatelets drugs)
• Patients with any oncological disease
• Patients with nasal septal deviation causing alteration of the nasal flux, polyps, anatomic/structural alterations (ex., tumors, leishmaniosis, etc.)
• Patients with any cardiovascular disease
• Patients with arterial hypertension
• Patients requiring halogenates anesthetics
• Patients with diabetes mellitus
• Patients with hyperthyroidism
• Patients with prostatic hypertrophy
• Patients with epilepsy or any other seizure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epinastine + Pseudoephedrine	Drug: Epinastine; Drug: Pseudoephedrine; Drug: Placebo; Placebo during run-in period
Experimental: Epinastine	Drug: Epinastine; Drug: Placebo; Placebo during run-in period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Changes in sneezing symptoms evaluated by investigator	Baseline and at the end of weeks 1, 2, 3, 4
Changes in lacrimation symptoms evaluated by investigator	Baseline and at the end of weeks 1, 2, 3, 4
Changes in rhinorrhea symptoms evaluated by patient using VAS	Baseline and at the end of weeks 1, 2, 3, 4
Changes in pruritus symptoms evaluated by patient using VAS	Baseline and at the end of weeks 1, 2, 3, 4
Changes in sneezing symptoms evaluated by patient using VAS	Baseline and at the end of weeks 1, 2, 3, 4
Changes in lacrimation symptoms evaluated by patient using VAS	Baseline and at the end of weeks 1, 2, 3, 4

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2000
• Primary Completion (Actual): July 1, 2001

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 14, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Ephedrine; Pseudoephedrine; Epinastine
• Other Study ID Numbers: 262.254