NCT01108783

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2010

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

4 months

First QC Date

April 21, 2010

Last Update Submit

April 4, 2012

Conditions

Seasonal Allergic Rhinitis

Keywords

RhinitisAllergicSeasonalHay FeverPollen AllergyPollinosisRhinoconjunctivitisSneezingNasal itchingNasal CongestionRhinorrheaOcular itchingOcular rednessTearing

Outcome Measures

Primary Outcomes (1)

  • AUC of TSS

    The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment.

    14 days

Secondary Outcomes (9)

  • Change in TSS. Reflective symptoms

    14 days

  • Change in TSS. Instantaneous score

    14 days

  • Change in total nasal symptom score (TNSS)

    14 days

  • Change in total non-nasal symptom score (TNNSS)

    14 days

  • VAS of discomfort

    14 days

  • +4 more secondary outcomes

Study Arms (3)

Bilastine

EXPERIMENTAL
Drug: Bilastine

Desloratadine

ACTIVE COMPARATOR
Drug: Desloratadine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BilastineDRUG

20 mg (encapsulated) tablets QD/14 days

Bilastine
DesloratadineDRUG

5 mg (encapsulated) tablets QD/14 days

Also known as: Aerius
Desloratadine
PlaceboDRUG

(encapsulated) Tablets QD/14 days

Placebo

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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..

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bachert C, Kuna P, Sanquer F, Ivan P, Dimitrov V, Gorina MM, van de Heyning P, Loureiro A; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy. 2009 Jan;64(1):158-65. doi: 10.1111/j.1398-9995.2008.01813.x.

    PMID: 19132976RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitisSneezingNasal ObstructionRhinorrheaLacerations

Interventions

bilastinedesloratadine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfectionsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsAirway ObstructionRespiratory InsufficiencyRespiration DisordersWounds and Injuries

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

April 21, 2010

First Posted

April 22, 2010

Study Start

April 1, 2003

Primary Completion

August 1, 2003

Study Completion

February 1, 2004

Last Updated

April 5, 2012

Record last verified: 2012-04