Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156819
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2005-09-08
Brief Title:
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Sponsor:
JHSPH Center for Clinical Trials
Organization:
JHSPH Center for Clinical Trials
Study Overview
Official Title:
The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Status:
COMPLETED
Status Verified Date:
2015-11
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 research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone an inhaled corticosteroid The treatments are fluticasone montelukast an antileukotriene drug and a combination therapy of fluticasone and salmeterol a long-acting beta-agonist Fluticasone montelukast and the combination therapy of fluticasone and salmeterol Advair Diskus are all approved for the treatment of asthma We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma
Detailed Description:
This trial will attempt to investigate whether asthmatic patients that are well controlled with low-dose twice daily inhaled corticosteroid ICS therapy can safely be switched to other modes of controller therapy without loss of asthma control Patients demonstrating good control on twice-daily low-dose ICS will be randomized to one of three treatment groups once-daily low-dose ICS fluticasone leukotriene receptor antagonist montelukast or once-daily combination therapy fluticasone-salmeterol
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