Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045955
Status:
COMPLETED
Last Update Posted:
2008-08-21
First Post:
2002-09-17
Brief Title:
Long-Term Safety Performance of Fexofenadine in Asthma
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Open-Label Randomized Parallel Groups Study to Assess the Long-Term Safety Performance of Fexofenadine Compared to Montelukast in Subjects With Asthma
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma
Detailed Description:
The incidence of respiratory allergy in the US has increased gradually over the past several years and current estimates suggest that allergic rhinitis and bronchial asthma affect approximately 20 and 5 of the population respectively Rhinitis and asthma frequently coexist and large-scale population surveys indicate that up to 38 of subjects with rhinitis have asthma and up to 78 of subjects with asthma have chronic nasal symptoms Safety concerns with the increased use of inhaled corticosteroids the heterogeneity of the disease and poor compliance with asthma medication regimens point to the need for the development of safe and convenient oral therapies for asthma Oral leukotriene receptor antagonists eg montelukast are the latest class of inflammation-modulating asthma drugs and appear to cause fewer long-term side effects than systemic corticosteroids and reduce the need for shorter-acting bronchodilator reliever medicines However variability in response between patients has been observed and clinical experience with these agents is still limited
Histamine is an important chemical mediator of inflammation in asthma The benefits of antihistamine treatment in patients with mild to moderate asthma have been well documented however their clinical use has been previously limited due to the high doses required for efficacy and their associated side effects including sedation and cognitive impairment Recent evidence indicates that in addition to H1-receptor antagonism some of the newer nonsedating non-impairing antihistamines appear to possess various anti-inflammatory properties at concentrations achieved at therapeutic dosages suggesting an additional benefit of these drugs in the management of allergic diseases and asthma The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma
Histamine is an important chemical mediator of inflammation in asthma The benefits of antihistamine treatment in patients with mild to moderate asthma have been well documented however their clinical use has been previously limited due to the high doses required for efficacy and their associated side effects including sedation and cognitive impairment Recent evidence indicates that in addition to H1-receptor antagonism some of the newer nonsedating non-impairing antihistamines appear to possess various anti-inflammatory properties at concentrations achieved at therapeutic dosages suggesting an additional benefit of these drugs in the management of allergic diseases and asthma The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma
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 |
|---|---|---|---|
| M016455 | None | None | None |