Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423995
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2007-01-17
Brief Title:
Effect of LoratadineMontelukast Combination on Congestion in SAR Patients Exposed to Pollen in an EEU Study P04822
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
Study of the Decongestant Effect of the Combination of Loratadine and Montelukast Compared With Placebo in SAR Subjects Exposed to Pollen in an Environmental Exposure Unit
Status:
COMPLETED
Status Verified Date:
2022-02
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 study of LMC phenylephrine and placebo in subjects with SAR There are three visits At Visit 1 subjects will be evaluated for participation and if they qualify will attend Visit 2 for priming At Visit 2 ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction Pollen counts will be monitored and recorded During the priming visits subjects will be evaluated to determine if they qualify If qualified they will return for Visit 3 where ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction Pollen counts will be monitored and recorded as in the Priming Session Subjects will complete symptom evaluations and if qualified they will receive study medication and remain in the environmental exposure unit where symptoms will be evaluated for 8 hours after dosing PNIF will be evaluated only during the treatment session Four nasal symptoms rhinorrhea nasal congestion sneezing and nasal itching and three non-nasal symptoms itchingburning eyes tearingwatery eyes and itching of earspalate will be evaluated Adverse events will be collected throughout the study to assess safety and tolerability and vital signs will be collected at Visit 1 and at the end of Visit 3
Detailed Description:
None
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