Allergic rhinitis, unspecified
Conditions
Interventions
A single group of 60 adolescents between 12 and 18 years of age with difficult to control persistent moderate to severe allergic rhinitis will receive the combination of intranasal azelastine and flut
Drug
D27.505.519.625.375.425
Sponsors
Hospital São Paulo - Universidade Federal de São Paulo
Hospital São Paulo - Universidade Federal de São Paulo
Eligibility
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: Adolescents between 12 and 18 years old; both genders; difficult to control moderate-severe persistent allergic rhinitis diagnosis; positive cutaneous immediate hypersensitivity test or specific serum IgE to inhalant allergens
Exclusion criteria
Exclusion criteria: Uncontrolled asthma; significant anatomical defects of the upper airway; systemic disease cognitive deficits; upper airways infection in the last 3 weeks; in use of systemic corticosteroid (last 30 days); in use of specific immunotherapy and immunosuppressants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the Brazilian Portuguese version of the Rhinitis Control Assessment Test (RCAT) questionnaire at the beginning of treatment and after 14 and 28 days. The RCAT is a self-administered questionnaire consisting of 6 questions regarding the symptoms experienced in the last week. Each question will receive scores ranging from 1 to 5 points according to the frequency of the symptoms (5: never, 4: rarely, 3: sometimes, 2: often, 1: extremely often). The final score is given by the sum of each question. Variation of total nasal symptoms score at the beginning of treatment and after 14 and 28 days. The clinical score will be assigned by the patient, using a questionnaire with a 0 to 3 scale, considering the following symptoms: runny nose, nasal congestion, itching and sneezing. Each symptom was scored as follows: 0 = no symptoms, 1 = mild symptoms (when present for a short time and without influence on the day-to-day life), 2 = moderate symptoms (when present often, but without influence on the day-to-day) and 3 = severe symptoms (when present most of the time with influence on daily activities or during sleep) The total nasal symptoms score (0-12 points) is given by the sum of the scores of each item. Variation of the visual analogue scale (0mm to 100mm, anchored by “no discomfort” (score of 0) and “maximum discomfort” (score of 100 [100-mm scale]), attributed by the patient at the beginning of treatment, after 14 and 28 days. Peak Nasal Inspiratory flow, quantified in liters per minute, at the start of treatment, after 14 and 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment adherence, assigned by the patient, assessed by a questionnaire 28 days after the start of treatment. The questionnaire will consider: good adherence (using more than 75% of doses), regular adherence (between 50 and 75% of doses) or bad (less than 50% of doses). Medical evaluation of the treatment, measured by a questionnaire assigned by the evaluating physician (controlled, partially controlled or uncontrolled rhinitis), 28 days after the start of treatment. Adverse drug events, described by the patient, 28 days after the start of treatment. Variation of extranasal symptoms score at the beginning of treatment and after 14 and 28 days. The clinical score will be assigned by the patient, using a questionnaire with a 0 to 3 scale, considering the following symptoms: Eye tearing, ocular pruritus, pharyngeal pruritus and ocular hyperemia. Each symptom was scored as follows: 0 = no symptoms, 1 = mild symptoms (when present for a short time and without influence on the day-to-day life), 2 = moderate symptoms (when present often, but without influence on the day-to-day) and 3 = severe symptoms (when present most of the time with influence on daily activities or during sleep) The total extranasal symptoms score is given by the sum of the scores of each item. | — |
Countries
Brazil
Contacts
Public ContactCarolina ;Fausto Boarini;Matsumoto
Hospital São Paulo - Universidade Federal de São Paulo;Hospital São Paulo - Universidade Federal de São Paulo
Outcome results
None listed