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CompletedNCT00574210Updated Feb 15, 2019

PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)

A Phase 2 interventional study of Bilastine and Placebo in Seasonal Allergic Rhinitis, Hay Fever and Rhinoconjunctivitis, sponsored by Faes Farma, S.A.. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Faes Farma, S.A. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
502
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months prior to randomization.

02

Conditions studied

  • Seasonal Allergic Rhinitis
  • Hay Fever
  • Rhinoconjunctivitis

Keywords

  • Seasonal Allergic Rhinitis (SAR)
  • Environmental Exposure Chamber (EEC)
  • Therapeutic Uses
  • Antihistamine Drug
  • Ragweed Pollen
03

In context

Rhinitis, Allergic, Seasonal

404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.

This study's enrollment of 502 is above the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.

Browse Rhinitis, Allergic, Seasonal studies →

Lead sponsor

Faes Farma, S.A. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical history of SAR for the last two ragweed allergy seasons.
  • A positive skin test within 12 months of screening to ragweed allergen.
  • A minimum qualifying symptom score on both Visits, 2 and 3.
  • Females must have a confirmed absence of pregnancy according to a negative urine pregnancy test.

Exclusion criteria

Exclusion Criteria:

  • Women who are pregnant, breastfeeding, or planning a pregnancy.
  • History of more than mild asthma.
  • History of (as determined by the Investigator) active perennial allergic rhinitis to which the subject is regularly exposed.
  • Non-allergic rhinitis (vasomotor or rhinitis medicamentosa).
  • An anatomic abnormality that interferes with assessment of nasal function. - History of clinically significant recurrent sinusitis or chronic sinusitis. - Clinically significant (as determined by the Investigator) cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other significant systemic disease that makes implementation of the protocol jeopardizing to the safety of the subject.
  • A need for use of antihistamines or on a regular basis (systemic or topical).
  • Currently taking monoamine oxidase (MAO) inhibitors.
  • Taken any systemic corticosteroids, immunomodulators, or immune suppressive medications within four weeks prior to Visit 1.
  • Taken any antihistamine within seven days prior to Visit 1 skin testing.
  • Known current alcohol or drug abuse.
  • Current participation in another clinical study involving an experimental treatment, or participation in such a study within 30 days prior to study entry. - History of generalized anaphylaxis requiring medical attention.
  • Clinically significant abnormality of screening blood chemistry, hematology, or urinalysis.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
502 participants (actual)

Study arms

  • Experimental
    1

    Bilastine oral 20 mg once per day (1 x 20 mg bilastine tablet plus 1 placebo tablet)

    Drug: Bilastine

  • Experimental
    2

    Bilastine oral 20 mg twice per day (2 x 20 mg bilastine tablets)

    Drug: Bilastine

  • Experimental
    3

    Bilastine oral 10 mg once per day (1 x 10 mg bilastine tablet plus 1 placebo tablet)

    Drug: Bilastine

  • Experimental
    4

    Bilastine oral 10 mg twice per day (2 x 10 mg bilastine tablets)

    Drug: Bilastine

  • Placebo comparator
    5

    Placebo oral twice per day (2 placebo tablets)

    Drug: Placebo

Interventions

  • DrugBilastine

    Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.

  • DrugPlacebo

    Placebo Tablets administered twice per day

06

What researchers measure

Primary outcomes

  1. Total Nasal Symptom Scores (TNSS)

    Time frame: within 10 days

Secondary outcomes

  1. Total Symptom Scores (TSS), Total Non-Nasal Symptom Scores (TNNSS), Total Ocular Symptoms Scores (TOSS), Area Under the Curve (AUC) of TNSS, TSS, TOSS, TNNSS, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ - EEC)

    Time frame: witin 10 days

07

Study locations

1 site
  • Allied Research International - Cetero Research
    Mississauga, Ontario 905-238-0599, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00574210
Lead sponsor
Faes Farma, S.A.
Collaborators
Allied Research International
Responsible party
Sponsor
First posted
Dec 17, 2007
Start date
Oct 2007
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Feb 15, 2019

Study contacts

Roman Valiente, MD
study chair · Faes Farma, S.A.
Piyush Patel, MD
study director · Allied Research International Inc
Deepen Patel, MD, CCFP
principal investigator · Allied Research International Inc

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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