Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

NCT00504933 | Completed Phase 3

• 2 other identifiers: BILA 1704/RAE2004-004586-14
• Study Type: interventional
• Target: 683
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

Rhinitis; Allergic; Seasonal; Hay Fever; Pollen Allergy; Pollinosis; Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms.

  14 days

Secondary Outcomes (5)

• AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms.

  14 days

• 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.

  14 days

• Overall assessment of discomfort caused by SAR using a visual analogue scale (VAS) on day 7 and day 14 vs. day 0.

• Investigator-rated Clinical Global Impression (CGI) - assessment of the therapeutic effect and AEs performed at day 14

• 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

Study Arms (3)

A

EXPERIMENTAL

Bilastine

Drug: bilastine

B

ACTIVE COMPARATOR

Cetirizine

Drug: Cetirizine

C

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

bilastine DRUG

20 mg (encapsulated) tablets QD/14days

A

Cetirizine DRUG

10 mg (encapsulated) tablets. QD/14 days

Also known as: Zyrtec

B

Placebo DRUG

(encapsulated) Tablets QD/14 days

C

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex between 12 and 70 years of age.
• Positive skin prick test for at least one of the seasonal allergen specific of the geographical area.

You may not qualify if:

• 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

Sponsors & Collaborators

• Faes Farma, S.A.: lead

Related Publications (4)

• 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.

  PMID: 22149770 BACKGROUND

• 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.

  PMID: 21831011 BACKGROUND

• 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.

  PMID: 22149338 BACKGROUND

• 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.

  PMID: 19438584 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis

Interventions

bilastine; Cetirizine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Piotr Kuna, Prof. Dr

  Barlicki University Hospital, Medical University of Lodz (Poland)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: May 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: April 5, 2012

Record last verified: 2012-04