Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119015
Status:
TERMINATED
Last Update Posted:
2014-02-28
First Post:
2005-07-01
Brief Title:
The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty in recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Some people with nasal allergy symptoms continue to have symptoms even after treatment with a nasal steroid spray The purpose of this study is to see if these patients are helped by adding another medication montelukast to their treatment compared to placebo a substance that looks like the active medication but does not contain the drug
Detailed Description:
Clinicians frequently prescribe an oral H1 antihistamine for allergic rhinitis patients with residual symptoms after taking an intranasal steroid Surprisingly the only studies investigating this combination of drugs have failed to show added efficacy of the H1 receptor over the intranasal steroids alone Adding montelukast a leukotriene receptor antagonist to an intranasal steroid has not been studied in a placebo controlled fashion Wilson and colleagues in an open study of patients with chronic rhinosinusitis showed a benefit of adding montelukast
The investigators would like to recruit perennially allergic subjects and place them on fluticasone for 2 weeks Those subjects with residual symptoms would then be randomized to receive either placebo or montelukast in addition to continuing the fluticasone for an additional 2 weeks
A positive study would support clinical practice and would serve as a preemptive strike against managed care plans that would not allow prescriptions for both drugs
Hypothesis
The addition of montelukast to treatment of a perennially allergic subject with an intranasal steroid is more effective at relieving symptoms than a placebo
The investigators would like to recruit perennially allergic subjects and place them on fluticasone for 2 weeks Those subjects with residual symptoms would then be randomized to receive either placebo or montelukast in addition to continuing the fluticasone for an additional 2 weeks
A positive study would support clinical practice and would serve as a preemptive strike against managed care plans that would not allow prescriptions for both drugs
Hypothesis
The addition of montelukast to treatment of a perennially allergic subject with an intranasal steroid is more effective at relieving symptoms than a placebo
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 |
|---|---|---|---|
| SING-US-60-04 | None | None | None |