Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245908
Status:
COMPLETED
Last Update Posted:
2005-10-28
First Post:
2005-10-27
Brief Title:
ASTHMA AntibioticS To Help Manage Asthma Pilot Study
Sponsor:
Wisconsin Research Network
Organization:
Wisconsin Research Network
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-01
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 ASTHMA Pilot Study is a randomized controlled parallel group clinical trial of 6 weekly doses of azithromycin cumulative dose 4800 mg or placebo as adjunctive treatment in addition to usual care for adults with stable persistent asthma with final follow up at 3 months after completion of study medication
The hypothesis to be tested is that antibiotic treatment will improve asthma at followup and that this improvement will be limited to patients with evidence of C pneumoniae infection
The secondary hypothesis is that randomized controlled treatment trials can be carried out successfully in a geographically dispersed practice-based research network
The hypothesis to be tested is that antibiotic treatment will improve asthma at followup and that this improvement will be limited to patients with evidence of C pneumoniae infection
The secondary hypothesis is that randomized controlled treatment trials can be carried out successfully in a geographically dispersed practice-based research network
Detailed Description:
Asthma is a chronic inflammatory bronchial condition of unknown etiology Decades ago many clinicians believed that infection played a major role in asthma etiology but current expert opinion favors the view that asthma is a noninfectious condition whose root cause is inflammation Therefore chronic antiinflammatory therapy mainly inhaled corticosteroids is currently advocated as primary anti-asthma treatment It is important to recognize however that antiinflammatory therapy is palliative not curative
A growing body of evidence implicates chronic bronchial infection with Chlamydia pneumoniae in the pathogenesis of asthma in both adults and children Organism identification studies culture and PCR suggest that up to one-half of children with asthma may be chronically infected by C pneumoniae and seroepidemiologic studies in adults are consistent with chronic C pneumoniae infection in the majority of adult-onset asthmatics Furthermore case reports and uncontrolled trials have provided provocative but inconclusive evidence that treatment of C pneumoniae infection in both children and adults with asthma can favorably affect the natural history of this disorder
We propose a randomized placebo-controlled triple-blinded study of antichlamydial antimicrobial therapy in adult-onset asthma Results will help to determine whether antimicrobial therapy is effective in treating some adult asthma syndromes Positive results would have significant public health implications Methodologies developed for use in this trial may expedite future studies in practice-based research networks
A growing body of evidence implicates chronic bronchial infection with Chlamydia pneumoniae in the pathogenesis of asthma in both adults and children Organism identification studies culture and PCR suggest that up to one-half of children with asthma may be chronically infected by C pneumoniae and seroepidemiologic studies in adults are consistent with chronic C pneumoniae infection in the majority of adult-onset asthmatics Furthermore case reports and uncontrolled trials have provided provocative but inconclusive evidence that treatment of C pneumoniae infection in both children and adults with asthma can favorably affect the natural history of this disorder
We propose a randomized placebo-controlled triple-blinded study of antichlamydial antimicrobial therapy in adult-onset asthma Results will help to determine whether antimicrobial therapy is effective in treating some adult asthma syndromes Positive results would have significant public health implications Methodologies developed for use in this trial may expedite future studies in practice-based research networks
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