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Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00504933
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : April 5, 2012
Information provided by (Responsible Party):
Faes Farma, S.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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: bilastine Drug: Cetirizine Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 683 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : May 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Experimental: A
Drug: bilastine
20 mg (encapsulated) tablets QD/14days

Active Comparator: B
Drug: Cetirizine
10 mg (encapsulated) tablets. QD/14 days
Other Name: Zyrtec

Placebo Comparator: C
Drug: Placebo
(encapsulated) Tablets QD/14 days

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms. [ Time Frame: 14 days ]
  2. 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 ]
  3. Overall assessment of discomfort caused by SAR using a visual analogue scale (VAS) on day 7 and day 14 vs. day 0.
  4. Investigator-rated Clinical Global Impression (CGI) - assessment of the therapeutic effect and AEs performed at day 14
  5. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00504933

Sponsors and Collaborators
Faes Farma, S.A.
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Principal Investigator: Piotr Kuna, Prof. Dr Barlicki University Hospital, Medical University of Lodz (Poland)
Publications of Results:
Other Publications:
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Responsible Party: Faes Farma, S.A. Identifier: NCT00504933    
Other Study ID Numbers: BILA 1704/RAE
2004-004586-14 ( EudraCT Number )
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012
Keywords provided by Faes Farma, S.A.:
Hay Fever
Pollen Allergy
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs