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NCT Number: NCT00420082

A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber

This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allergy Center Vienna West

Vienna, A-1150, Austria

About this study

The objective of the study is to determine the effect of a single dose of bilastine 20 mg on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge Chamber . This effect will be compared to that action of Cetirizine 10 mg, Fexofenadine 120 mg, and placebo. To explore the onset of action, patients will receive study drug two hours after the start of the provocation on Day 1.Patients will remain in theVCC for an additional four hours. On Day 2, patients will return to the VCC post-dose hours 22-26.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a history of seasonal allergic rhinitis
  • Have a positive (as defined in the protocol) skin prick or RAST test within 12 months prior to the screening visit

Exclusion criteria

  • Have a clinically significant illness or disease
  • Have unstable asthma
  • Has participated in a clinical trial 30 days prior to the screening visit

Treatment and study plan

Bilastine

Drug

Encapsulated Bilastine 20 mg tablets Q.D.

fexofenadine

Drug

Encapsulated Fexofenadine 120 mg tablets Q.D.

Other names: Allegra

Cetirizine

Drug

Encapsulated Cetirizine 10 mg tablets Q.D.

Other names: Zyrtec

Placebo

Drug

Encapsulated Placebo tablets Q.D.

Primary outcomes

  1. Onset of action and action duration

Secondary outcomes

  1. Nasal and ocular symptom scores

  2. Nasal airflow resistance

  3. Nasal secretion weight

  4. FEV1

  5. Routine safety parameters (vital signs, ECGs, clinical laboratory tests)

Sponsors and collaborators

Lead sponsor

Faes Farma, S.A.

Industry

Registry information

Official study title

A Randomized, Double-Blind, 4 Way Cross-over, Placebo Controlled Trial to Evaluate the Onset of Action of Bilastine 20 mg vs. Placebo, Cetirizine 10 mg, and Fexofenadine 120 mg in the Vienna Challenge Chamber

Important dates

Study start
2006
Study completion
2006
First posted
Jan 9, 2007
Registry last updated
Apr 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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