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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Faes Farma, S.A.
ClinicalTrials.gov Identifier:
NCT01108783
First received: April 21, 2010
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Seasonal Allergic Rhinitis
 Drug: Bilastine
Drug: Desloratadine
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, 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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

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

Primary Outcome Measures:
  • AUC of TSS [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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:
  • Change in TSS. Reflective symptoms [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.

  • Change in TSS. Instantaneous score [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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).

  • Change in total nasal symptom score (TNSS) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.

  • Change in total non-nasal symptom score (TNNSS) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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

  • VAS of discomfort [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.

  • CGI [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Investigator's overall clinical impression (CGI)

  • Allergic rhinitis (AR) quality of life (QoL) questionnaire [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Quality of Life change versus baseline.

  • Onset of action [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Symptoms assessment in the first 48 hours since the beginning of the treatment

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


Enrollment: 720
Study Start Date: April 2003
Study Completion Date: February 2004
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108783

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: NCT01108783     History of Changes
Other Study ID Numbers: BILA 1003/RAE
Study First Received: April 21, 2010
Last Updated: April 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Ministry of Health
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Bulgaria: Bulgarian Drug Agency

Keywords provided by Faes Farma, S.A.:
Rhinitis
Allergic
Seasonal
Hay Fever
Pollen Allergy
Pollinosis
Rhinoconjunctivitis
 Sneezing
Nasal itching
Nasal Congestion
Rhinorrhea
Ocular itching
Ocular redness
Tearing

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

ClinicalTrials.gov processed this record on May 23, 2013