ASTHMA (AntibioticS To Help Manage Asthma) Pilot Study

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245908
• Other study ID #: HSC Protocol 98-370-277
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2005
• Last updated: October 27, 2005
• Start date: September 1999
• Est. completion date: September 2002

Study information

• Verified date: January 2002
• Source: Wisconsin Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults with stable persistent asthma and evidence for reversible airway obstruction

Exclusion Criteria:

• macrolide allergy, pregnancy or lactation, specified comorbidities or medications

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• azithromycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wisconsin Research Network

References & Publications (1)

Hahn DL, Plane MB. Feasibility of a practical clinical trial for asthma conducted in primary care. J Am Board Fam Pract. 2004 May-Jun;17(3):190-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	None specified (pilot study)
Primary	Clinical outcomes measured: asthma symptoms, medication use, asthma-specific qulaity-of-life
Primary	Serological measures: Chlamydia pneumonaie IgG, IgA by ELISA at baseline and follow up