Recruitment, Retention and Adherence in an Under-funded AZMATICS Study

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Recruitment, Retention and Adherence in an
Under-funded AZMATICS Study
David L. Hahn, M.D., M.S. (Epidemiology) Dept.
Family Practice, Dean Medical Center Clinical
Professor, U. Wisconsin Dept. Family Medicine
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AZithroMycin and AsthmaTrial In Community
Settings

• Chlamydia pneumoniae and asthma
• Kochs postulates
• Hills criteria
• Effectiveness RCT
• Pilot results

http//www.dean.org/index.php/info/asthma
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ASTHMA Pilot Study results
Hahn DL, Plane MB, Mahdi OS, Byrne GI. Secondary
outcomes of a pilot randomized trial of
azithromycin treatment for asthma. PLoS Clin
Trials. 20061(2)e11 DOI 10.1371/journal.pctr001
0011.
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Effectiveness versus Efficacy

• Efficacy
• Highly selected population
• Lots of exclusions
• Get rid of noise
• Effectiveness
• Representative population
• Minimize exclusions
• Noise Our Patients

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Effectiveness Studies the Ideal
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Asthma Studies the Reality
Travers J, Marsh S, Williams M, et al. External
validity of randomised controlled trials in
asthmato whom do the results of the trials
apply? Thorax. 200762219-223. Herland K,
Akselsen J-P, Skjønsberg OH, Bjermer L. How
representative are clinical study patients with
asthma or COPD for a larger "real life"
population of patients with obstructive lung
disease? Respir Med. 20059911-19
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Current Clinical Trials
AZMATICS MIA
Setting PBRNs ACRN
No. subjects 600 144
Treatment Azithro,x12w Clarithro,x16w
Duration 1 year 6 months
1o Outcome Symptoms Control
Design Effectiveness Efficacy
Cost 3.5M 12.5M
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Underfunded AZMATICS

• Email/Internet Data Collection
• Volunteer Study Clinicians
• Volunteer Study Subjects
• Symptoms, Med Use, QOL, Exacerbations
• No Pulmonary Function
• No Biomarkers

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Recruitment
22 Individuals randomized 74 subjects
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Recruitment
20 Eligible Subjects Declined Randomization
N20
N74
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Subject Demographics
Randomized (74) Open Label (20)
Age, median (range) 46 (21-80) 44 (21-80)
Gender 51F, 23M 8F, 12M
Smoking, current 16 0
Asthma onset, Age 23 (0-57) 21 (6-53)
Infectious, 33 55
Pure Asthma, 77 85
AS-CAO, 12 5
Prior attacks, 64 60
Baseline severity 1.4Day, 1.6Noc 2.0Day, 1.8Noc
Plt.05
Plt.01
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Subject Retention
Randomized Cohort
31
60
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Main Findings

• Despite inadequate funding
• AZMATICS is being successfully implemented
• AZMATICS will provide Level 2 Evidence
• Completion rate lt80
• An external validity control group is potentially
  important
• Open Label subjects are different

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Summary

• Effectiveness studies are long overdue
• The evidence for infection in asthma is robust
• Practice-based RCTs are feasible and should be
  funded

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Final Comment
No Funding is Not Enough