Clinical trial NCT00504933: Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis
Official title: Double-blind, Randomised, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Cetirizine 10 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
Lead sponsor: Faes Farma, S.A.
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 683
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 is to evaluate the efficacy and tolerability of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of seasonal allergic rhinitis.

Detailed description: In this pivotal, multicentre, international, randomized, double-blind, placebo and active-comparator controlled, parallel study, 683 patients with SAR will be enrolled. Patients will be required to be 12-70 years old, have SAR for ≥2 years, a positive skin test, total nasal and non-nasal score (TSS) ≥36 (out of 72) during run-in, and a composite instantaneous nasal symptom score ≥6 (out of 12) the morning before randomization. The primary efficacy endpoint will be the AUC of reflective TSS from baseline to Day 14.

Eligibility criteria: Inclusion Criteria:

* Patients of either sex between 12 and 70 years of age.
* Patients with documented clinical history of SAR, for at least 2 years prior to the study inclusion.
* Positive skin prick test for at least one of the seasonal allergen specific of the geographical area.
* A previous positive Prick test, or a positive IgE Test (RAST) may also be accepted for inclusion, if performed within 12 months prior to the inclusion.

Exclusion Criteria:

* Patients who have non-allergic rhinitis (vasomotor, infectious, drug-induced, etc.).
* Negative skin prick test (as defined in point 6.1.1.).
* Patients with nasal polyps or a significant deviation of the nasal septum as judged by the investigator as well as nasal intervention in the previous 6 months. Any other nasal illness that can interfere with the aim of the study.
* Patients who have acute or chronic sinusitis as judged by the investigator.
* Patients who have received anti-allergy immunotherapy in the previous two years or are still receiving this kind of therapy.
* Patients who are taking or have taken specified medications prior to randomisation in the study and have not complied with the specified washout period

Primary outcomes:
measure: Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms.
timeFrame: 14 days
Secondary outcomes:
measure: AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms.
timeFrame: 14 days
measure: Change from baseline at day 7 and day 14 for the following: Patient-rated (reflective and instantaneous) and Investigator-rated (instantaneous; assessed during study visit) TSS, NSS, NNSS and change for each individual symptom.
timeFrame: 14 days
measure: Overall assessment of discomfort caused by SAR using a visual analogue scale (VAS) on day 7 and day 14 vs. day 0.
measure: Investigator-rated Clinical Global Impression (CGI) - assessment of the therapeutic effect and AEs performed at day 14
measure: Responders Rate: responders will be classified based on their TSS decrease from baseline: no responders (<25%), >25%<50%, >50%<75%, >75% and will be described by treatment group with their percentage
Other outcomes:
Locations:
Study officials:
affiliation: Barlicki University Hospital, Medical University of Lodz (Poland)
name: Piotr Kuna, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bousquet J, Ansotegui I, Canonica GW, Zuberbier T, Baena-Cagnani CE, Bachert C, Cruz AA, Gonzalez SN, Kuna P, Morais-Almeida M, Mullol J, Ryan DP, Sanchez-Borges M, Valiente R, Church MK. Establishing the place in therapy of bilastine in the treatment of allergic rhinitis according to ARIA: evidence review. Curr Med Res Opin. 2012 Jan;28(1):131-9. doi: 10.1185/03007995.2011.648263. Epub 2011 Dec 22.
citation: Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. doi: 10.1517/14740338.2011.604029. Epub 2011 Aug 11.
citation: Jauregui I, Garcia-Lirio E, Soriano AM, Gamboa PM, Antepara I. An overview of the novel H1-antihistamine bilastine in allergic rhinitis and urticaria. Expert Rev Clin Immunol. 2012 Jan;8(1):33-41. doi: 10.1586/eci.11.87.
citation: Kuna P, Bachert C, Nowacki Z, van Cauwenberge P, Agache I, Fouquert L, Roger A, Sologuren A, Valiente R; Bilastine International Working Group. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study. Clin Exp Allergy. 2009 Sep;39(9):1338-47. doi: 10.1111/j.1365-2222.2009.03257.x. Epub 2009 May 4.