Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Faes Farma, S.A.
ClinicalTrials.gov Identifier:
NCT00504933
First received: July 19, 2007
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: bilastine
Drug: Cetirizine
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Faes Farma, S.A.:

Primary Outcome Measures:
  • Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Overall assessment of discomfort caused by SAR using a visual analogue scale (VAS) on day 7 and day 14 vs. day 0. [ Designated as safety issue: No ]
  • Investigator-rated Clinical Global Impression (CGI) - assessment of the therapeutic effect and AEs performed at day 14 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Enrollment: 683
Study Start Date: May 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Bilastine
Drug: bilastine
20 mg (encapsulated) tablets QD/14days
Active Comparator: B
Cetirizine
Drug: Cetirizine
10 mg (encapsulated) tablets. QD/14 days
Other Name: Zyrtec
Placebo Comparator: C
Placebo
Drug: Placebo
(encapsulated) Tablets QD/14 days

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

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504933

Sponsors and Collaborators
Faes Farma, S.A.
Investigators
Principal Investigator: Piotr Kuna, Prof. Dr Barlicki University Hospital, Medical University of Lodz (Poland)
  More Information

Publications:
Responsible Party: Faes Farma, S.A.
ClinicalTrials.gov Identifier: NCT00504933     History of Changes
Other Study ID Numbers: BILA 1704/RAE, 2004-004586-14
Study First Received: July 19, 2007
Last Updated: April 4, 2012
Health Authority: Spain: Spanish Agency of Medicines
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Romania: National Medicines Agency
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health

Keywords provided by Faes Farma, S.A.:
Rhinitis
Allergic
Seasonal
Hay Fever
Pollen Allergy
Pollinosis
Rhinoconjunctivitis

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Cetirizine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014