Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069823
Status:
COMPLETED
Last Update Posted:
2012-12-19
First Post:
2003-10-01
Brief Title:
Study of Acid Reflux in Asthma
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
The Study of Acid Reflux in Asthma
Status:
COMPLETED
Status Verified Date:
2012-12
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 study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor PPI drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment
Detailed Description:
BACKGROUND
Gastroesophageal reflux GERD is frequent in asthmatics with poor asthma control often occurs without symptoms and can induce bronchoconstriction Poorly controlled asthmatics are often treated for GERD with drugs that suppress gastric acid but this treatment is expensive and the benefit of such treatment is not established Proton pump inhibitors are a relatively new class of medications that provide highly effective treatment for GERD and associated problems This success has led many doctors to begin PPI treatment in their asthma patients in an attempt to achieve better asthma control
DESIGN NARRATIVE
The randomized placebo-controlled trial will enroll 400 asthmatics ages 18 or older who have poor asthma control on inhaled steroids defined on the basis of excessive bronchodilator use nocturnal awakenings or frequent exacerbations Participants will be randomly assigned to treatment with either a proton pump inhibitor esomeprazole Nexium 40 mg twice a day or matching placebo The presence severity and temporal relationship of GERD to asthma symptoms will be documented with 24 hour ambulatory esophageal potential Hydrogen pH probe monitoring but participants will be enrolled irrespective of the severity of GERD The primary outcome measure is the proportion of participants who have exacerbations of asthma within a 6-month period defined by asthma diaries and interviews Secondary outcome measures include asthma symptom and control scores asthma-specific and generic health-related quality of life GERD symptoms health care use pulmonary function and airways reactivity Pre-specified subgroup analyses will be conducted to determine if there are clinical or demographic characteristics that predict benefit from treatment of GERD in asthma
Gastroesophageal reflux GERD is frequent in asthmatics with poor asthma control often occurs without symptoms and can induce bronchoconstriction Poorly controlled asthmatics are often treated for GERD with drugs that suppress gastric acid but this treatment is expensive and the benefit of such treatment is not established Proton pump inhibitors are a relatively new class of medications that provide highly effective treatment for GERD and associated problems This success has led many doctors to begin PPI treatment in their asthma patients in an attempt to achieve better asthma control
DESIGN NARRATIVE
The randomized placebo-controlled trial will enroll 400 asthmatics ages 18 or older who have poor asthma control on inhaled steroids defined on the basis of excessive bronchodilator use nocturnal awakenings or frequent exacerbations Participants will be randomly assigned to treatment with either a proton pump inhibitor esomeprazole Nexium 40 mg twice a day or matching placebo The presence severity and temporal relationship of GERD to asthma symptoms will be documented with 24 hour ambulatory esophageal potential Hydrogen pH probe monitoring but participants will be enrolled irrespective of the severity of GERD The primary outcome measure is the proportion of participants who have exacerbations of asthma within a 6-month period defined by asthma diaries and interviews Secondary outcome measures include asthma symptom and control scores asthma-specific and generic health-related quality of life GERD symptoms health care use pulmonary function and airways reactivity Pre-specified subgroup analyses will be conducted to determine if there are clinical or demographic characteristics that predict benefit from treatment of GERD in asthma
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 |
|---|---|---|---|
| U01HL072968 | NIH | None | httpsreporternihgovquickSearchU01HL072968 |