Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine

Allergic Rhinitis Clinical Trial

— QolRhinitis  

Official title:

Quality of Life in Patients With Allergic Rhinitis: a Clinical Trial Comparing the Use of Bilastine Versus Loratadine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513290
• Other study ID #: CTBixLo
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2018
• Source: Universidade do Sul de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Bilastine

• Loratadine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Sul de Santa Catarina

References & Publications (5)

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. — View Citation

Carter NJ. Bilastine: in allergic rhinitis and urticaria. Drugs. 2012 Jun 18;72(9):1257-69. doi: 10.2165/11209310-000000000-00000. Review. — View 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. — View Citation

Nascimento Silva M, Naspitz C, Solé 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life in patients with allergic rhinitis	Application of the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm)	10 days