Rhinitis, Allergic Respiratory Tract Diseases
Conditions
Interventions
This was an interventional, randomized, controlled, open-label, two-arm parallel-group study with an active comparator. A total of 150 participants with persistent allergic rhinitis were assessed, eig
Sponsors
Faculdade São Leopoldo Mandic
Unidade de Pronto Atendimento Professor Simão dos Santos Figueira – Garanhuns
Centro de Reabilitação e Equoterapia Santa Clara
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants aged 18 years or older; both genders; clinical diagnosis of persistent allergic rhinitis; presence of nasal symptoms such as nasal obstruction, rhinorrhea, sneezing or nasal itching; clinical indication for treatment with intranasal budesonide or loratadine combined with montelukast; agreement to participate in the study by signing the Informed Consent Form
Exclusion criteria
Exclusion criteria: Participants with known hypersensitivity to budesonide, loratadine or montelukast; presence of acute respiratory infection at enrollment; presence of chronic respiratory diseases unrelated to allergic rhinitis that could interfere with the results; pregnant or breastfeeding participants; recent use of medications that could interfere with the assessment of nasal symptoms or quality of life; refusal to participate in the study or absence of signature on the Informed Consent Form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: A reduction in the total Visual Analog Scale score for allergic rhinitis symptoms is expected between baseline evaluation and evaluation after 30 days of treatment. The Visual Analog Scale will include five items: rhinorrhea, sneezing, nasal obstruction, nasal itching, and ocular symptoms. Each item will be scored from 0 to 10, with a total score ranging from 0 to 50 points. Higher scores will indicate greater symptom severity. Clinically significant improvement will be defined as a reduction of at least 30% in the total score;Outcome found 1: A reduction in the total Visual Analog Scale score for allergic rhinitis symptoms was observed after 30 days of treatment in both groups. Mean scores decreased from approximately 42 points at baseline to 11.5 points in the budesonide group and 11.6 points in the montelukast combined with loratadine group, corresponding to reductions of 72.3% and 71.9%, respectively. Clinically significant improvement, defined as a reduction of at least 30% in the total score, was observed in 96% of participants in the budesonide group and in 93% of participants in the montelukast combined with loratadine group. There was no statistically significant difference between groups regarding final scores ;Expected outcome 2: A reduction in the total score of the quality-of-life instrument adapted from the Rhinoconjunctivitis Quality of Life Questionnaire is expected between baseline evaluation and evaluation after 30 days of treatment. The instrument will assess seven domains: daily activities, sleep, practical problems, emotions, general symptoms, nasal symptoms, and other symptoms. Each domain will be scored from 0 to 6, with a total score ranging from 0 to 42 points. Higher scores will indicate worse quality of life. Clinically significant improvement will be defined as a reduction of at least 20% in the total score ;Outcome found 2: A reduction in the total score of the quality-of-life instrument adapted from the Rhinoconjunct | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 3: Treatment adherence is expected to be assessed after 30 days of follow-up, verified by self-report and medication diary, considering the number of doses correctly used during the intervention period. Adherence will be classified as high when 80% or more of the prescribed doses are used, intermediate between 50% and 79%, low between 20% and 49%, and non-adherence when treatment is discontinued or less than 20% of the expected doses are used ;Outcome found 3: Treatment adherence was assessed in 142 participants who completed the 30-day follow-up. In the budesonide group, 42 participants, corresponding to 59.2%, had high adherence, 19 participants, corresponding to 26.8%, had intermediate adherence, and 10 participants, corresponding to 14.1%, had low adherence. In the montelukast combined with loratadine group, 48 participants, corresponding to 67.6%, had high adherence, 16 participants, corresponding to 22.5%, had intermediate adherence, and 7 participants, corresponding to 9.9%, had low adherence. There was no statistically significant difference between groups regarding treatment adherence distribution;Expected outcome 4: The occurrence of adverse events is expected to be assessed during the 30 days of treatment, verified by participant report during clinical follow-up. Adverse events will be considered any unfavorable symptoms or clinical occurrences reported during the intervention period, regardless of confirmation of a causal relationship with the medications used;Outcome found 4: Adverse events were recorded in both groups during follow-up. In the budesonide group, 8 of 71 participants, corresponding to 11.3%, reported at least one adverse event, the most frequent being nasal irritation in 6 participants, corresponding to 8.5%, and throat irritation in 2 participants, corresponding to 2.8%. One case of severe skin rash, corresponding to 1.4%, was also recorded and led to treatment discontinuation. In the montelukast combined with loratadin | — |
Countries
BR
Contacts
Public ContactPablo Lima
Faculdade São Leopoldo Mandic
Outcome results
None listed