A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine

Seasonal Allergic Rhinitis Clinical Trial

Official title:

Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Desloratadine 5 mg for the Treatment of Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108783
• Other study ID #: BILA 1003/RAE
• Status: Completed
• Phase: Phase 3
• First received: April 21, 2010
• Last updated: April 4, 2012
• Start date: April 2003
• Est. completion date: February 2004

Study information

• Verified date: April 2012
• Source: Faes Farma, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Poland: Ministry of HealthBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentPortugal: National Pharmacy and Medicines InstituteRomania: National Medicines AgencyBulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial Summary

The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.

Description:

Pivotal, double-blind, randomized, placebo-controlled, comparative with desloratadine, parallel group, international, multicenter study.The Primary endpoint was the Change in total reflective score on the scale of symptoms associated with seasonal allergic rhinitis indicated by patients at the baseline assessment and over the 2 weeks of the study. A total of 720 patients with seasonal allergic rhinitis were enrolled. Duration of treatment was 14 days, preceded by one week (7 days) of placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: February 2004
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

Inclusion Criteria:

• The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering.

• Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination..

Exclusion Criteria:

• Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed.

• Patients were not allowed to take forbidden medications or not comply the study requirements.

• Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded.

• Pregnant or breast-feeding women were also excluded.

• Women of childbearing potential had a pregnancy test done

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Bilastine
20 mg (encapsulated) tablets QD/14 days
• Desloratadine
5 mg (encapsulated) tablets QD/14 days
• Placebo
(encapsulated) Tablets QD/14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Faes Farma, S.A.

References & Publications (1)

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. Allerg — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of TSS	The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment.	14 days	No
Secondary	Change in TSS. Reflective symptoms	Change in the reflective total score on symptom scale on D14 visit and day7 visit versus D0 visit (baseline) according to the patient´s assessment on the previous 12 hours.	14 days	No
Secondary	Change in TSS. Instantaneous score	Change in the total score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's assessment (instantaneous score).	14 days	No
Secondary	Change in total nasal symptom score (TNSS)	Change in nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment.	14 days	No
Secondary	Change in total non-nasal symptom score (TNNSS)	Change in non-nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment	14 days	No
Secondary	VAS of discomfort	Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.	14 days	No
Secondary	CGI	Investigator's overall clinical impression (CGI)	14 days	Yes
Secondary	Allergic rhinitis (AR) quality of life (QoL) questionnaire	Quality of Life change versus baseline.	14 days	No
Secondary	Onset of action	Symptoms assessment in the first 48 hours since the beginning of the treatment	2 days	No
Secondary	Safety assessment	comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.	14 days	Yes