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

NCT ID: NCT02182518

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Epinastine + Pseudoephedrine

Group Type: EXPERIMENTAL

Epinastine

Intervention Type: DRUG

Pseudoephedrine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Placebo during run-in period

Epinastine

Group Type: EXPERIMENTAL

Epinastine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Placebo during run-in period

Interventions

Epinastine

Intervention Type: DRUG

Pseudoephedrine

Intervention Type: DRUG

Placebo

Placebo during run-in period

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

262.254

Identifier Type: -

Identifier Source: org_study_id