NCT00245908

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_3 asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
Last Updated

October 28, 2005

Status Verified

January 1, 2002

First QC Date

October 27, 2005

Last Update Submit

October 27, 2005

Conditions

Asthma

Keywords

AsthmaChlamydia pneumoniaeChlamydophila pneumoniaeAzithromycin

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

azithromycinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.3122/jabfm.17.3.190.

    PMID: 15226283BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • David L Hahn, MD, MS

    Wisconsin Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 28, 2005

Study Start

September 1, 1999

Study Completion

September 1, 2002

Last Updated

October 28, 2005

Record last verified: 2002-01