Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-04 @ 2:57 PM
Study NCT ID:
NCT02182518
Status:
COMPLETED
Last Update Posted:
2014-07-14
First Post:
2014-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epinastine + Pseudoephedrine SR (Slow Release) Versus Epinastine Alone in Patients With Perennial Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053090', 'term': 'epinastine'}, {'id': 'D054199', 'term': 'Pseudoephedrine'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-11', 'studyFirstSubmitDate': '2014-07-02', 'studyFirstSubmitQcDate': '2014-07-07', 'lastUpdatePostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Classification of severity of nasal blockage by Visual Analog Scale (VAS)', 'timeFrame': 'at the end of weeks 1, 2, 3, 4'}, {'measure': 'Incidence of laboratory alterations', 'timeFrame': 'day 14, 28 and 35'}, {'measure': 'Incidence of premature discontinuations of the study due to adverse events', 'timeFrame': 'up to 4 weeks'}, {'measure': 'Incidence and severity of all adverse events', 'timeFrame': 'up to 5 weeks'}], 'secondaryOutcomes': [{'measure': 'Daily evaluation of the nasal blockage by the patient', 'timeFrame': 'daily up to 4 weeks'}, {'measure': 'Classification of the severity of the symptoms by the investigator', 'timeFrame': 'at the end of weeks 1, 2, 3, 4'}, {'measure': 'Changes in nasal physical examination', 'timeFrame': 'Baseline and at the end of weeks 1, 2, 3, 4'}, {'measure': 'Changes in rhinorrhea symptoms evaluated by investigator', 'timeFrame': 'Baseline and at the end of weeks 1, 2, 3, 4'}, {'measure': 'Changes in pruritus symptoms evaluated by investigator', 'timeFrame': 'Baseline and at the end of weeks 1, 2, 3, 4'}, {'measure': 'Changes in sneezing symptoms evaluated by investigator', 'timeFrame': 'Baseline and at the end of weeks 1, 2, 3, 4'}, {'measure': 'Changes in lacrimation symptoms evaluated by investigator', 'timeFrame': 'Baseline and at the end of weeks 1, 2, 3, 4'}, {'measure': 'Changes in rhinorrhea symptoms evaluated by patient using VAS', 'timeFrame': 'Baseline and at the end of weeks 1, 2, 3, 4'}, {'measure': 'Changes in pruritus symptoms evaluated by patient using VAS', 'timeFrame': 'Baseline and at the end of weeks 1, 2, 3, 4'}, {'measure': 'Changes in sneezing symptoms evaluated by patient using VAS', 'timeFrame': 'Baseline and at the end of weeks 1, 2, 3, 4'}, {'measure': 'Changes in lacrimation symptoms evaluated by patient using VAS', 'timeFrame': 'Baseline and at the end of weeks 1, 2, 3, 4'}]}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic, Perennial']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female outpatients\n* Over 12 years old\n* 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\n* Patients with an established diagnosis of allergic perennial rhinitis under the clinical criteria (allergic to one or more allergens)\n* Patients with moderate or complete nasal blockage characterizes by ≥50 mm in the VAS for this parameter during visits 1 and 2\n* Patients with positive (≥3 mm compared to the negative control) skin test ("Prick Test") to one or more of the following allergens:\n\n * Dermatophagoides pteronyssinus\n * Dermatophagoides farinae\n * Blomia tropicalis\n * Alternaria alternata\n * Cladosporium herbarum\n * Aspergillus fumigatus\n * Penicillium notatum\n * cat\'s fur\n * dog\'s fur\n\nExclusion Criteria:\n\n* Pregnant or breast feeding women, or women without contraceptive method who:\n\n * are not in the postmenopausal period and/or\n * have not been submitted to bilateral tubal ligation or hysterectomy and/or\n * are not under one of the following contraceptive control:\n\n * oral contraceptive\n * IUD (intrauterine device)\n * diaphragm\n* Patients unable to understand, accept or follow the protocol instructions\n* History of serious adverse events with antihistamines\n* Patients under treatment with calcium antagonists or other antihypertensive drugs\n* Patients under treatment with digitalis\n* Patients under treatment with MAO (monoamine oxidase) inhibitors\n* Patients under treatment with sympathicomimetics\n* Patients that have received any of the following drugs during the periods specified below, before visit 1:\n\n * Inhaled/Topics\n\n * short acting β2 agonists (12 hours)\n * long acting β2 agonists (48 hours)\n * ipratropium bromide (12 hours)\n * nasal drops without vasoconstrictors (3 days)\n * DSCG (disodium cromoglycate) (3 days)\n * nedocromil (7 days)\n * nasal drops with vasoconstrictors (7 days)\n * azelastine (14 days)\n * levocabastine (14 days)\n * corticosteroids (30 days)\n * corticosteroids on the site of Prick test (3 months)\n * other investigational drug (3 months)\n * Oral\n\n * short acting β2 agonists (18 hours)\n * short acting theophylline (24 hours)\n * phenothiazines (48 hours)\n * long acting theophylline (72 hours)\n * anticholinergics (7 days)\n * antihistamines (except astemizole) (7 days)\n * MAO (monoamine oxidase) inhibitors (14 days)\n * corticosteroids (30 days)\n * ketotifen (3 months)\n * imipramine (30 days)\n * astemizole (2 months)\n * other investigational drugs (3 months)\n * Parenteral\n\n * aminophylline (24 hours)\n * phenothiazines (48 hours)\n * antihistamines (7 days)\n * corticosteroids (30 days)\n * imipramine (30 days)\n * other investigational drugs (3 months)\n* Patients under desensitization therapy\n* Patients under therapy with antibiotics\n* Patients with non compensate endocrine disease\n* Patients with atrophic rhinitis\n* Patients with rhinitis due to acetylsalicylic acid\n* Patients with acute or chronic infectious sinusitis\n* Patients with asthma, that need treatment with beta-2 agonists more than twice per week\n* Patients with glaucoma\n* Patients with history or renal and/or hepatic failure\n* Patients with known platelets dysfunction due to any disease or to drugs (purpura thrombocytopenic idiopathic, use of anticoagulants, use of antiplatelets drugs)\n* Patients with any oncological disease\n* Patients with nasal septal deviation causing alteration of the nasal flux, polyps, anatomic/structural alterations (ex., tumors, leishmaniosis, etc.)\n* Patients with any cardiovascular disease\n* Patients with arterial hypertension\n* Patients requiring halogenates anesthetics\n* Patients with diabetes mellitus\n* Patients with hyperthyroidism\n* Patients with prostatic hypertrophy\n* Patients with epilepsy or any other seizure'}, 'identificationModule': {'nctId': 'NCT02182518', 'briefTitle': 'Epinastine + Pseudoephedrine SR (Slow Release) Versus Epinastine Alone in Patients With Perennial Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '262.254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epinastine + Pseudoephedrine', 'interventionNames': ['Drug: Epinastine', 'Drug: Pseudoephedrine', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Epinastine', 'interventionNames': ['Drug: Epinastine', 'Drug: Placebo']}], 'interventions': [{'name': 'Epinastine', 'type': 'DRUG', 'armGroupLabels': ['Epinastine', 'Epinastine + Pseudoephedrine']}, {'name': 'Pseudoephedrine', 'type': 'DRUG', 'armGroupLabels': ['Epinastine + Pseudoephedrine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo during run-in period', 'armGroupLabels': ['Epinastine', 'Epinastine + Pseudoephedrine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}