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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT02182518

Collaborator

(none)

101

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Perennial	Drug: Epinastine Drug: Pseudoephedrine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

101 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

May 1, 2000

Actual Primary Completion Date :

Jul 1, 2001

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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