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

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: Bilastine; Drug: Desloratadine

• Registration Number: NCT01108783
• Lead Sponsor: Faes Farma, S.A.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2003-08
• Study Completion: 2004-02
• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-04
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 720

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..

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Bilastine	Bilastine	-
Desloratadine	Desloratadine	-

Primary Outcome Measures

Name	Time	Method
AUC of TSS	14 days	The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment.

Secondary Outcome Measures

Name	Time	Method
Change in TSS. Reflective symptoms	14 days	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.
Change in TSS. Instantaneous score	14 days	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).
Change in total nasal symptom score (TNSS)	14 days	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.
Change in total non-nasal symptom score (TNNSS)	14 days	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
VAS of discomfort	14 days	Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.
CGI	14 days	Investigator's overall clinical impression (CGI)
Allergic rhinitis (AR) quality of life (QoL) questionnaire	14 days	Quality of Life change versus baseline.
Onset of action	2 days	Symptoms assessment in the first 48 hours since the beginning of the treatment
Safety assessment	14 days	comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.