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

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ClinicalTrials.gov Identifier: NCT02182518
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

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Study Type : Interventional  (Clinical Trial)
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 2000
Actual Primary Completion Date : July 2001

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Classification of severity of nasal blockage by Visual Analog Scale (VAS) [ Time Frame: at the end of weeks 1, 2, 3, 4 ]
  2. Incidence of laboratory alterations [ Time Frame: day 14, 28 and 35 ]
  3. Incidence of premature discontinuations of the study due to adverse events [ Time Frame: up to 4 weeks ]
  4. Incidence and severity of all adverse events [ Time Frame: up to 5 weeks ]

Secondary Outcome Measures :
  1. Daily evaluation of the nasal blockage by the patient [ Time Frame: daily up to 4 weeks ]
  2. Classification of the severity of the symptoms by the investigator [ Time Frame: at the end of weeks 1, 2, 3, 4 ]
  3. Changes in nasal physical examination [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  4. Changes in rhinorrhea symptoms evaluated by investigator [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  5. Changes in pruritus symptoms evaluated by investigator [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  6. Changes in sneezing symptoms evaluated by investigator [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  7. Changes in lacrimation symptoms evaluated by investigator [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  8. Changes in rhinorrhea symptoms evaluated by patient using VAS [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  9. Changes in pruritus symptoms evaluated by patient using VAS [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  10. Changes in sneezing symptoms evaluated by patient using VAS [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]
  11. Changes in lacrimation symptoms evaluated by patient using VAS [ Time Frame: Baseline and at the end of weeks 1, 2, 3, 4 ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182518    
Other Study ID Numbers: 262.254
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pseudoephedrine
Ephedrine
Epinastine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents