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ASTHMA (AntibioticS To Help Manage Asthma) Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245908
First Posted: October 28, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wisconsin Research Network
  Purpose

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.


Condition Intervention Phase
Asthma Drug: azithromycin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Wisconsin Research Network:

Primary Outcome Measures:
  • None specified (pilot study)
  • Clinical outcomes measured: asthma symptoms, medication use, asthma-specific qulaity-of-life
  • Serological measures: Chlamydia pneumonaie IgG, IgA by ELISA at baseline and follow up

Estimated Enrollment: 100
Study Start Date: September 1999
Estimated Study Completion Date: September 2002
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • macrolide allergy, pregnancy or lactation, specified comorbidities or medications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245908


Sponsors and Collaborators
Wisconsin Research Network
Investigators
Principal Investigator: David L Hahn, MD, MS Wisconsin Research Network
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00245908     History of Changes
Other Study ID Numbers: HSC Protocol 98-370-277
First Submitted: October 27, 2005
First Posted: October 28, 2005
Last Update Posted: December 9, 2005
Last Verified: January 2002

Keywords provided by Wisconsin Research Network:
Asthma
Chlamydia pneumoniae
Chlamydophila pneumoniae
Azithromycin

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases