Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-04 @ 5:37 PM
Study NCT ID:
NCT04077892
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2019-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare the Effect of INS Alone and Added LTRA in Treatment of SAR
Sponsor:
Beijing Tongren Hospital
Organization:
Study Overview
Official Title:
A Randomized Trial of Comparing a Combination of Montelukast and Budesonide With Budesonide in Allergic Rhinitis
Status:
COMPLETED
Status Verified Date:
2019-09
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:
It is not proven unequivocally whether a combination of an intranasal corticosteroids (INS) and a cysteinyl leukotriene receptor antagonist has greater efficacy than INS in the treatment of severe allergic rhinitis (AR) . We performed a randomized, open-label study in 46 seasonal AR subjects receiving budesonide (BD, 256ug) plus montelukast (MNT, 10 mg) or BD alone (256ug) for 2 weeks. Visual analog scale (VAS) scores, nasal cavity volume (NCV), nasal airway resistance (NAR) and fractional exhaled nitric oxide (FeNO) were assessed before and at end of treatments as the primary treatment outcomes. Similarly, histamine, eosinophil cationic protein (ECP) and cysteinyl-leukotrienes (Cyslts) in nasal secretion and Th1/Th2 cells in nasal mucosa were evaluated as the secondary treatment outcomes.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: