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

NCT02513290 | Completed Phase 4 DMC

• 1 other identifier: CTBixLo
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis

Keywords

quality of life; allergic rhinitis; bilastine; loratadine; clinical trial

Outcome Measures

Primary Outcomes (1)

• Quality of life in patients with allergic rhinitis

  Application of the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm)

  10 days

Study Arms (2)

Bilastine group

EXPERIMENTAL

Bilastine 20 mg administered once a day for ten days.

Drug: Bilastine

Loratadine group

EXPERIMENTAL

Loratadine 10 mg administered once a day for ten days.

Drug: Loratadine

Interventions

Bilastine DRUG

Also known as: Alektos

Bilastine group

Loratadine DRUG

Also known as: Claritin, Histadin, Loranil, Loritil, Loralerg

Loratadine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Sul de Santa Catarina: lead

Related Publications (5)

• 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.

  PMID: 10452758 BACKGROUND

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

  PMID: 22686617 BACKGROUND

• 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.

  PMID: 11674923 BACKGROUND

• 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.

  PMID: 19132976 BACKGROUND

• 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.

  PMID: 10848909 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

bilastine; Loratadine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Jane da Silva, PhD

  Universidade do Sul de Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 31, 2015
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 7, 2018

Record last verified: 2018-05