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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Rhinitis, Allergic, Perennial

Treatments

Drug: Placebo

Drug: Pseudoephedrine

Drug: Epinastine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02182518

262.254

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

All

Ages

12+ years old

Volunteers

No 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