A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine

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: NCT01108783
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : April 5, 2012
Information provided by (Responsible Party):
Faes Farma, S.A.

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Bilastine Drug: Desloratadine Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2003
Actual Primary Completion Date : August 2003
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

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

Active Comparator: Desloratadine Drug: Desloratadine
5 mg (encapsulated) tablets QD/14 days
Other Name: Aerius

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

Primary Outcome Measures :
  1. AUC of TSS [ Time Frame: 14 days ]
    The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment.

Secondary Outcome Measures :
  1. Change in TSS. Reflective symptoms [ Time Frame: 14 days ]
    Change in the reflective total score on symptom scale on D14 visit and day7 visit versus D0 visit (baseline) according to the patient´s assessment on the previous 12 hours.

  2. Change in TSS. Instantaneous score [ Time Frame: 14 days ]
    Change in the total score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's assessment (instantaneous score).

  3. Change in total nasal symptom score (TNSS) [ Time Frame: 14 days ]
    Change in nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment.

  4. Change in total non-nasal symptom score (TNNSS) [ Time Frame: 14 days ]
    Change in non-nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment

  5. VAS of discomfort [ Time Frame: 14 days ]
    Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.

  6. CGI [ Time Frame: 14 days ]
    Investigator's overall clinical impression (CGI)

  7. Allergic rhinitis (AR) quality of life (QoL) questionnaire [ Time Frame: 14 days ]
    Quality of Life change versus baseline.

  8. Onset of action [ Time Frame: 2 days ]
    Symptoms assessment in the first 48 hours since the beginning of the treatment

  9. Safety assessment [ Time Frame: 14 days ]
    comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.

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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:

  • 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

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): NCT01108783

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

Publications of Results:
Responsible Party: Faes Farma, S.A. Identifier: NCT01108783     History of Changes
Other Study ID Numbers: BILA 1003/RAE
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012

Keywords provided by Faes Farma, S.A.:
Hay Fever
Pollen Allergy
Nasal itching
Nasal Congestion
Ocular itching
Ocular redness

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