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

Rhinitis, Allergic, Perennial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182518
• Other study ID #: 262.254
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2014
• Last updated: July 11, 2014
• Start date: May 2000

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 ß2 agonists (12 hours)

• long acting ß2 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 ß2 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 Design

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Epinastine

• Pseudoephedrine

• Placebo
Placebo during run-in period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classification of severity of nasal blockage by Visual Analog Scale (VAS)		at the end of weeks 1, 2, 3, 4	No
Primary	Incidence of laboratory alterations		day 14, 28 and 35	No
Primary	Incidence of premature discontinuations of the study due to adverse events		up to 4 weeks	No
Primary	Incidence and severity of all adverse events		up to 5 weeks	No
Secondary	Daily evaluation of the nasal blockage by the patient		daily up to 4 weeks	No
Secondary	Classification of the severity of the symptoms by the investigator		at the end of weeks 1, 2, 3, 4	No
Secondary	Changes in nasal physical examination		Baseline and at the end of weeks 1, 2, 3, 4	No
Secondary	Changes in rhinorrhea symptoms evaluated by investigator		Baseline and at the end of weeks 1, 2, 3, 4	No
Secondary	Changes in pruritus symptoms evaluated by investigator		Baseline and at the end of weeks 1, 2, 3, 4	No
Secondary	Changes in sneezing symptoms evaluated by investigator		Baseline and at the end of weeks 1, 2, 3, 4	No
Secondary	Changes in lacrimation symptoms evaluated by investigator		Baseline and at the end of weeks 1, 2, 3, 4	No
Secondary	Changes in rhinorrhea symptoms evaluated by patient using VAS		Baseline and at the end of weeks 1, 2, 3, 4	No
Secondary	Changes in pruritus symptoms evaluated by patient using VAS		Baseline and at the end of weeks 1, 2, 3, 4	No
Secondary	Changes in sneezing symptoms evaluated by patient using VAS		Baseline and at the end of weeks 1, 2, 3, 4	No
Secondary	Changes in lacrimation symptoms evaluated by patient using VAS		Baseline and at the end of weeks 1, 2, 3, 4	No

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