Ignite Creation Date:
2024-05-06 @ 7:56 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02635334
Status:
COMPLETED
Last Update Posted:
2016-10-05
First Post:
2015-12-10
Brief Title:
Asthma in the Elderly The Effect of Montelukast
Sponsor:
Rohr and Columbo Asthma Allergy and Immunology Specialists PC
Organization:
Rohr and Columbo Asthma Allergy and Immunology Specialists PC
Study Overview
Official Title:
Asthma in the Elderly A Randomized Double-Blind Placebo-Controlled Cross-Over Study of the Effect of Montelukast
Status:
COMPLETED
Status Verified Date:
2016-10
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 a pilot study of the effect of montelukast in subjects with asthma who are 65 years old and older Montelukast is a leukotriene receptor antagonist US FDA approved for the treatment of asthma in subjects who are 12 month old and older This study is being done because there has been no placebo controlled study of montelukast focused on this group of patients Elderly asthmatics have been mostly ignored in asthma studies They are more likely to be underdiagnosed undertreated and hospitalized for asthma when compared to younger asthmatics The pathophysiology of asthma in the elderly is typically different than in younger patients This is a double-blind placebo-controlled crossover study Investigators plan to enroll thirty subjects who have been diagnosed with asthma for at least one year are non smoker and did not smoke for more than 10 packyear of tobacco products in their lifetime After a run-in period of one week the study subjects will take montelukast 10 mg orally for 8 weeks first and then placebo for 8 weeks or vice versa Primary objectives of this study are to evaluate the effect of montelukast on asthma symptoms assessed by daily symptom scores the Asthma Control Test and the number of puffs of albuterol and spirometric values FEV1 Secondary objectives include studying whether montelukast affects peripheral blood eosinophils counts and serum IgE levels
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