Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200967
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2005-09-12
Brief Title:
Asthma Clinical Research Network ACRN Trial - Long-Acting Beta Agonist Response by Genotype LARGE
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Asthma Clinical Research Network ACRN Trial - Long-Acting Beta Agonist Response by Genotype LARGE
Status:
COMPLETED
Status Verified Date:
2017-12
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:
The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist salmeterol in the setting of concomitant use of inhaled corticosteroids beclomethasone hydroflouroalkane HFA inhaler will have a detrimental effect on asthma control in people who bear the B16-ArgArg genotype of the beta-2 adrenergic receptor gene as compared to people with asthma of similar severity who bear the B16-GlyGly genotype
Detailed Description:
BACKGROUND
The purpose of this study is to compare the effects of a long-acting beta agonist in patients with asthma receiving inhaled corticosteroids who express two distinct polymorphisms of the beta-2 adrenergic receptor
DESIGN NARRATIVE
Participants were homozygous for arginine or glycine at the 16th amino-acid position of the β-2 adrenergic receptor B16 ArgArg or B16 GlyGly Individuals were matched against their opposite genotype by forced expiratory volume in one second FEV1 and race Matched participants entered an 8-week run-in period This is a 62-week crossover design where subjects receive the following therapies
Beclomethasone HFA 240 µg twice a day BID as-needed PRN albuterol 8-week run-in
Beclomethasone HFA 240 µg BID salmeterol 50 µg BID PRN ipratropium bromide PRN albuterol 18-week treatment period
Beclomethasone HFA 240 µg BID PRN albuterol 8-week run-out
Beclomethasone HFA 240 µg BID placebo salmeterol PRN ipratropium bromide PRN albuterol 18-week treatment period
Beclomethasone HFA 240 µg BID PRN albuterol 10-week run-out
The order of treatments received during the two treatment periods is randomized
The purpose of this study is to compare the effects of a long-acting beta agonist in patients with asthma receiving inhaled corticosteroids who express two distinct polymorphisms of the beta-2 adrenergic receptor
DESIGN NARRATIVE
Participants were homozygous for arginine or glycine at the 16th amino-acid position of the β-2 adrenergic receptor B16 ArgArg or B16 GlyGly Individuals were matched against their opposite genotype by forced expiratory volume in one second FEV1 and race Matched participants entered an 8-week run-in period This is a 62-week crossover design where subjects receive the following therapies
Beclomethasone HFA 240 µg twice a day BID as-needed PRN albuterol 8-week run-in
Beclomethasone HFA 240 µg BID salmeterol 50 µg BID PRN ipratropium bromide PRN albuterol 18-week treatment period
Beclomethasone HFA 240 µg BID PRN albuterol 8-week run-out
Beclomethasone HFA 240 µg BID placebo salmeterol PRN ipratropium bromide PRN albuterol 18-week treatment period
Beclomethasone HFA 240 µg BID PRN albuterol 10-week run-out
The order of treatments received during the two treatment periods is randomized
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 |
|---|---|---|---|
| U10HL074231 | NIH | None | httpsreporternihgovquickSearchU10HL074231 |
| 5U10HL074231 | NIH | None | None |
| U10HL074073 | NIH | None | None |
| U10HL074204 | NIH | None | None |
| U10HL074208 | NIH | None | None |
| U10HL074212 | NIH | None | None |
| U10HL074227 | NIH | None | None |
| U10HL074218 | NIH | None | None |
| U10HL074225 | NIH | None | None |