A Phase 2 interventional study of Bilastine and Fexofenadine in Seasonal Allergic Rhinitis, sponsored by Faes Farma, S.A.. Completed at 1 site in Austria. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2012-04-05.
Sponsored by Faes Farma, S.A. · Phase 2, Interventional, and Treatment
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.
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 75 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Faes Farma, S.A. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bilastine 20 mg
Drug: Bilastine
Fexofenadine 120 mg
Drug: Fexofenadine
Cetirizine 10 mg
Drug: Cetirizine
Placebo
Drug: Placebo
Encapsulated Bilastine 20 mg tablets Q.D.
Encapsulated Fexofenadine 120 mg tablets Q.D.
Also known as: Allegra
Encapsulated Cetirizine 10 mg tablets Q.D.
Also known as: Zyrtec
Encapsulated Placebo tablets Q.D.
Onset of action and action duration
Nasal and ocular symptom scores
Nasal airflow resistance
Nasal secretion weight
FEV1
Routine safety parameters (vital signs, ECGs, clinical laboratory tests)
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Faes Farma, S.A.