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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis, Allergic, Perennial

Intervention: Epinastine (Drug); Pseudoephedrine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

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

Incidence of laboratory alterations

Incidence of premature discontinuations of the study due to adverse events

Incidence and severity of all adverse events

Secondary outcome:

Daily evaluation of the nasal blockage by the patient

Classification of the severity of the symptoms by the investigator

Changes in nasal physical examination

Changes in rhinorrhea symptoms evaluated by investigator

Changes in pruritus symptoms evaluated by investigator

Changes in sneezing symptoms evaluated by investigator

Changes in lacrimation symptoms evaluated by investigator

Changes in rhinorrhea symptoms evaluated by patient using VAS

Changes in pruritus symptoms evaluated by patient using VAS

Changes in sneezing symptoms evaluated by patient using VAS

Changes in lacrimation symptoms evaluated by patient using VAS

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: May 2000
Last updated: July 11, 2014

Page last updated: August 20, 2015

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