Clinical trial NCT01108783: A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: Rhinitis
Allergic
Seasonal
Hay Fever
Pollen Allergy
Pollinosis
Rhinoconjunctivitis
Sneezing
Nasal itching
Nasal Congestion
Rhinorrhea
Ocular itching
Ocular redness
Tearing
Lead sponsor: Faes Farma, S.A.
Sponsor class: INDUSTRY
First posted: 2010-04-22
Enrollment: 720
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: AUC of TSS
timeFrame: 14 days
Secondary outcomes:
measure: Change in TSS. Reflective symptoms
timeFrame: 14 days
measure: Change in TSS. Instantaneous score
timeFrame: 14 days
measure: Change in total nasal symptom score (TNSS)
timeFrame: 14 days
measure: Change in total non-nasal symptom score (TNNSS)
timeFrame: 14 days
measure: VAS of discomfort
timeFrame: 14 days
measure: CGI
timeFrame: 14 days
measure: Allergic rhinitis (AR) quality of life (QoL) questionnaire
timeFrame: 14 days
measure: Onset of action
timeFrame: 2 days
measure: Safety assessment
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Barlicki University Hospital, Medical University of Lodz (Poland)
name: Piotr Kuna, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.