Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420082
Status:
COMPLETED
Last Update Posted:
2012-04-05
First Post:
2007-01-08
Brief Title:
A Randomized Double-Blind 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber
Sponsor:
Faes Farma SA
Organization:
Faes Farma SA
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 1Patients will remain in theVCC for an additional four hours On Day 2 patients will return to the VCC post-dose hours 22-26
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-003004-19 | EUDRACT_NUMBER | None | None |