Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162864
Status:
COMPLETED
Last Update Posted:
2006-03-24
First Post:
2005-09-08
Brief Title:
A Pilot Study of Montelukast Sodium Singulair in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
A Pilot Study of Montelukast Sodium Singulair in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2005-09
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:
This randomized double-blind placebo-controlled trial assessed the efficacy of montelukast in the treatment of adults 50 years of age with persistent asthma andor COPD Primary outcomes included forced expiratory volume in one-second FEV1 and daytime asthma symptoms scores Nocturnal symptoms asthma control health-related quality of life peak flow measurements and health care utilization were also assessed as secondary outcomes Participants were recruited from the Kaiser Permanente Northwest member population One hundred forty-nine subjects were randomized to treatment with montelukast 10 mg per day or placebo and were followed for a six-week period No differences in lung function measures health-related quality of life health care utilization and asthma symptom scores were observed however the montelukast group had slightly improved asthma control scores compared to the placebo group
Detailed Description:
Asthma and COPD are common chronic conditions in older adults Adherence to therapy is an important consideration since patients typically take two or more medications a day and often have difficulties with inhaled breathing medications Therefore oral preparations such as leukotriene modifiers have considerable appeal for older adults with asthma or COPD Phase 3 primary studies of the leukotriene modifier montelukast sodium Singulair for the management of asthma have included very few older adults
The following randomized double-blind placebo-controlled study was designed as a pilot study to evaluate the efficacy of montelukast in addition to usual therapy in the treatment of older adults with asthma andor COPD Primary outcomes included pre-bronchodilator forced expiratory volume in one-second FEV1 and average daytime asthma symptom scores
Participants were recruited from Kaiser Permanente Northwest KPNW an HMO with 450000 members in Portland OR All were adults 50 years of age with asthma andor COPD who were symptomatic despite using daily breathing medications They were screened by phone to collect information on asthma symptoms medications health care utilization and co-morbid illnesses Eligible persons attended a baseline visit to further assess eligibility and collect baseline data including smoking status co-morbidities and participant demographics Spirometry was performed before and twenty minutes after administration of four puffs of inhaled albuterol delivered by metered dose inhaler All participants received instructions about the use of a peak flow meter maintenance of a daily asthma diary with peak flow measurements symptoms and medications and optimal use of an MDI by spacer
Participants completed a two-week run-in period with placebo pills and used diaries to record peak flow each morning use of inhaled ß-agonist nocturnal awakenings for asthma and occurrence of asthma attacks
A total of 149 participants were randomized and received either montelukastone 10 mg tabletday N71 or placeboone tabletday N78 Spirometry was repeated at the randomization visit and information on health status asthma quality of life and asthma control was collected Participants were followed for 6 weeks after randomization A telephone call was made at three-weeks to collect information about adverse experiences At the final visit participants completed spirometry and answered questions on health status asthma QOL and asthma control Unscheduled health care visits for asthma during the six-week study period were noted
Results showed that improvement in asthma control was mixed A small improvement in the montelukast group was seen using one of the two control measures There was no difference in lung function asthma symptom scores health care utilization or health-related quality of life between the treatment and control groups
The following randomized double-blind placebo-controlled study was designed as a pilot study to evaluate the efficacy of montelukast in addition to usual therapy in the treatment of older adults with asthma andor COPD Primary outcomes included pre-bronchodilator forced expiratory volume in one-second FEV1 and average daytime asthma symptom scores
Participants were recruited from Kaiser Permanente Northwest KPNW an HMO with 450000 members in Portland OR All were adults 50 years of age with asthma andor COPD who were symptomatic despite using daily breathing medications They were screened by phone to collect information on asthma symptoms medications health care utilization and co-morbid illnesses Eligible persons attended a baseline visit to further assess eligibility and collect baseline data including smoking status co-morbidities and participant demographics Spirometry was performed before and twenty minutes after administration of four puffs of inhaled albuterol delivered by metered dose inhaler All participants received instructions about the use of a peak flow meter maintenance of a daily asthma diary with peak flow measurements symptoms and medications and optimal use of an MDI by spacer
Participants completed a two-week run-in period with placebo pills and used diaries to record peak flow each morning use of inhaled ß-agonist nocturnal awakenings for asthma and occurrence of asthma attacks
A total of 149 participants were randomized and received either montelukastone 10 mg tabletday N71 or placeboone tabletday N78 Spirometry was repeated at the randomization visit and information on health status asthma quality of life and asthma control was collected Participants were followed for 6 weeks after randomization A telephone call was made at three-weeks to collect information about adverse experiences At the final visit participants completed spirometry and answered questions on health status asthma QOL and asthma control Unscheduled health care visits for asthma during the six-week study period were noted
Results showed that improvement in asthma control was mixed A small improvement in the montelukast group was seen using one of the two control measures There was no difference in lung function asthma symptom scores health care utilization or health-related quality of life between the treatment and control groups
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-75-99 | None | None | None |