Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266851
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2005-12-15
Brief Title:
AZMATICS AZithroMycinAsthma Trial In Community Settings
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
AZMATICS Azithromycin Asthma Trial In Community Settings
Status:
COMPLETED
Status Verified Date:
2019-07
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 assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma
Research Question Will a 12-week treatment with the antibiotic azithromycin result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma
Experimental Design The investigators propose a one-year randomized placebo-controlled blinded investigator patient data collector data analyst trial of 12 weekly doses of azithromycinplacebo as adjunctive therapy in addition to usual care along with a parallel observational cohort who will participate open label in 100 adult asthma patients recruited from practice-based research networks eg Wisconsin Research and Education Network WREN and others This practical clinical trial will 1 enroll a representative sample of asthma patients encountered in the practices of primary care physicians 2 employ standard clinical trial methodology to ensure internally valid results and 3 measure outcomes important to patients so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers
Active study sites -
Wisconsin Augusta Cross Plains La Crosse Marshfield Milwaukee Madison
Mauston Rice Lake Tomah Wausau
Colorado Monument
Illinois Peoria
Nevada Reno
North Carolina Granite Falls
North Dakota Minot
Ohio Cleveland Berea
Oklahoma Ardmore Claremore Edmond Lawton Oklahoma City Stroud Tulsa Weatherford
Rhode Island East Providence
Research Question Will a 12-week treatment with the antibiotic azithromycin result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma
Experimental Design The investigators propose a one-year randomized placebo-controlled blinded investigator patient data collector data analyst trial of 12 weekly doses of azithromycinplacebo as adjunctive therapy in addition to usual care along with a parallel observational cohort who will participate open label in 100 adult asthma patients recruited from practice-based research networks eg Wisconsin Research and Education Network WREN and others This practical clinical trial will 1 enroll a representative sample of asthma patients encountered in the practices of primary care physicians 2 employ standard clinical trial methodology to ensure internally valid results and 3 measure outcomes important to patients so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers
Active study sites -
Wisconsin Augusta Cross Plains La Crosse Marshfield Milwaukee Madison
Mauston Rice Lake Tomah Wausau
Colorado Monument
Illinois Peoria
Nevada Reno
North Carolina Granite Falls
North Dakota Minot
Ohio Cleveland Berea
Oklahoma Ardmore Claremore Edmond Lawton Oklahoma City Stroud Tulsa Weatherford
Rhode Island East Providence
Detailed Description:
10 PROTOCOL SYNOPSIS
Approximately 100 eligible adult patients with physician-diagnosed asthma will either be randomized to 12-week treatment with azithromycin or an identical placebo or join an observational open-label azithromycin cohort Azithromycin is a widely marketed azalide antibiotic with an excellent safety profile Azithromycin or placebo will be adjunctive therapy for usual asthma care The following patient-reported data will be collected via Zoomerang a commercially-available data collection tool periodically until one year after randomization 1 study medication adherence and side effects weekly until 12 weeks 2 asthma control and exacerbations every 6 weeks until 12 months and 3 asthma quality of life and asthma controller medication changes every 3 months until 12 months The primary hypothesis is that azithromycin will significantly improve asthma control decrease symptoms and medication use by 3 months end treatment and the improvement will continue to 12 months end study The primary outcome variable is overall asthma symptoms Secondary outcomes are asthma medication use quality of life and exacerbations We will examine the predictive value of baseline patient characteristics including age sex smoking co-morbid respiratory diagnoses and degree of airflow limitation We will also examine for any imbalances between study groups in controller medication use other antibiotic prescriptions and acute respiratory illnesses during the one-year study period
We will enroll subjects from the practices of Wisconsin Research and Education Network WREN members UW Department of Family Medicine physicians Dean Medical Center primary care physicians and from other practice-based research networks PBRNs medical group practices and individual primary care practices throughout North America
Patients with physician-diagnosed asthma aged 18 and older will be identified at point-of-service office urgent care emergency room or hospital by administrative data base review or by physician recall Most subjects will be the patients of study physicians Other physicians in the group practice may refer subjects Subjects also may be self-referred after responding to posters placed in the clinics Some sites may elect to identify cases by medical record or database review in which case only the personal physician may initiate patient contacts
Treatment is azithromycin tablets 600 milligrams orally once daily for 3 days then 600 milligrams once weekly for an additional 11 weeks total dose 8400 milligrams or identical placebo in addition to usual care for asthma
Approximately 100 eligible adult patients with physician-diagnosed asthma will either be randomized to 12-week treatment with azithromycin or an identical placebo or join an observational open-label azithromycin cohort Azithromycin is a widely marketed azalide antibiotic with an excellent safety profile Azithromycin or placebo will be adjunctive therapy for usual asthma care The following patient-reported data will be collected via Zoomerang a commercially-available data collection tool periodically until one year after randomization 1 study medication adherence and side effects weekly until 12 weeks 2 asthma control and exacerbations every 6 weeks until 12 months and 3 asthma quality of life and asthma controller medication changes every 3 months until 12 months The primary hypothesis is that azithromycin will significantly improve asthma control decrease symptoms and medication use by 3 months end treatment and the improvement will continue to 12 months end study The primary outcome variable is overall asthma symptoms Secondary outcomes are asthma medication use quality of life and exacerbations We will examine the predictive value of baseline patient characteristics including age sex smoking co-morbid respiratory diagnoses and degree of airflow limitation We will also examine for any imbalances between study groups in controller medication use other antibiotic prescriptions and acute respiratory illnesses during the one-year study period
We will enroll subjects from the practices of Wisconsin Research and Education Network WREN members UW Department of Family Medicine physicians Dean Medical Center primary care physicians and from other practice-based research networks PBRNs medical group practices and individual primary care practices throughout North America
Patients with physician-diagnosed asthma aged 18 and older will be identified at point-of-service office urgent care emergency room or hospital by administrative data base review or by physician recall Most subjects will be the patients of study physicians Other physicians in the group practice may refer subjects Subjects also may be self-referred after responding to posters placed in the clinics Some sites may elect to identify cases by medical record or database review in which case only the personal physician may initiate patient contacts
Treatment is azithromycin tablets 600 milligrams orally once daily for 3 days then 600 milligrams once weekly for an additional 11 weeks total dose 8400 milligrams or identical placebo in addition to usual care for asthma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None