Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02182518
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT02182518
Study Brief:
Protocol Section:
NCT02182518