Clinical trial NCT02513290: Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine
Official title: Quality of Life in Patients With Allergic Rhinitis: a Clinical Trial Comparing the Use of Bilastine Versus Loratadine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: quality of life
allergic rhinitis
bilastine
loratadine
clinical trial
Lead sponsor: Universidade do Sul de Santa Catarina
Sponsor class: OTHER_GOV
First posted: 2015-07-31
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to verify whether there were differences in health-related quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to those treated with loratadine 10 mg.

Detailed description: This was a prospective randomized double-blinded study, in which patients were recruited from august 2013 until august 2014. Outpatients attended in 4 otolaryngology clinics from Criciúma, state of Santa Catarina, Brazil were invited to participate of the study. They were aged between 18 and 63 years. Seventy-three patient were included, of whom 36 were treated with loratadine 10 mg and 37 with bilastine 20 mg with medication administered once a day for ten days. The primary outcome was quality of life, assessed by the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm), which was applied at baseline and after 10 days of treatment.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of allergic rhinitis (a typical history of rhinitis symptoms: coryza, sneezing, nasal obstruction, nasal itching, and eye symptoms, and hypersensitivity tests for specific IgE measured by Radioallergosorbent Test (RAST) or skin tests
* patients classified as with intermittent rhinitis (symptoms during less than 4 days per week) or persistent rhinitis (symptoms during more than 4 days per week) of moderate to severe intensity (annoyance impairing the quality and quantity of sleep and interfering with daily activities)

Exclusion Criteria:

* pregnancy or breast-feeding;
* non-allergic rhinitis (vasomotor, infectious or drug-induced);
* known hypersensitivity to antihistamines;
* clinical disorders that might affect the assessment;
* nasal diseases that could lead to complete blockage or one of the nostrils blockage, such as tumors or septal deviation;
* therapy with immunotherapy;
* use of antihistamines or disodium cromoglycate within the past four weeks;
* use of topical or systemic corticosteroids, immunosuppressants or any investigational drug within the last two weeks;
* use of topical antihistamines or nasal decongestants within the last 48 hours;
* use of deposit steroid within the last month.

Primary outcomes:
measure: Quality of life in patients with allergic rhinitis
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidade do Sul de Santa Catarina
name: Jane da Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juniper EF, Thompson AK, Ferrie PJ, Roberts JN. Validation of the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire. J Allergy Clin Immunol. 1999 Aug;104(2 Pt 1):364-9. doi: 10.1016/s0091-6749(99)70380-5.
citation: Carter NJ. Bilastine: in allergic rhinitis and urticaria. Drugs. 2012 Jun 18;72(9):1257-69. doi: 10.2165/11209310-000000000-00000.
citation: Nascimento Silva M, Naspitz C, Sole D. Evaluation of quality of life in children and teenagers with allergic rhinitis: adaptation and validation of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Allergol Immunopathol (Madr). 2001 Jul-Aug;29(4):111-8. doi: 10.1016/s0301-0546(01)79042-8.
citation: Bachert C, Kuna P, Sanquer F, Ivan P, Dimitrov V, Gorina MM, van de Heyning P, Loureiro A; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy. 2009 Jan;64(1):158-65. doi: 10.1111/j.1398-9995.2008.01813.x.
citation: Van Cauwenberge P, Juniper EF. Comparison of the efficacy, safety and quality of life provided by fexofenadine hydrochloride 120 mg, loratadine 10 mg and placebo administered once daily for the treatment of seasonal allergic rhinitis. Clin Exp Allergy. 2000 Jun;30(6):891-9. doi: 10.1046/j.1365-2222.2000.00914.x.