AZMATICS: AZithroMycin/Asthma Trial In Community Settings

NCT00266851

Last updated date
Study Location
ANSR
Peoria, Illinois, 61602, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age 18 and older (and at least 50 kg/110 pounds)

- The lower weight limit was chosen to avoid exposure to greater than 12 mg/kg/day of azithromycin (a currently recommended dose for children)

- We specify no upper age limit because asthma occurs throughout the age range and because asthma in the elderly is particularly severe and warrants inclusion.

- Physician-diagnosed asthma

- At the time of randomization, eligible subjects must either:

- be having a documented asthma exacerbation OR

- be reporting at least mild persistent asthma symptoms, as defined by GINA (Global Initiative for Asthma)

- Subjects must also have asthma symptoms for at least six months prior to randomization

- Documentation of objective evidence of reversible airway obstruction, either spontaneously or after treatment, is required prior to randomization. This requirement can be met by documentary evidence, within 2 years of randomization, of either:

- a 12% or greater (and ≥200 mL) change in FEV1 OR

- a 25% or greater (and >60 L/min) change in PEFR either spontaneously or as a result of treatment

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Not English literate or without email and internet access


- Macrolide allergy


- Pregnancy or lactation


- Females of childbearing potential must agree to use an acceptable form of
contraception during the treatment period


- Chronic use of macrolides, tetracyclines or quinolones Chronic use is defined as 4 or
more weeks of continuous use within 6 months of randomization


- Asthma symptoms for less than 6 months prior to randomization Asthma symptoms must be
present for at least 6 months to exclude patients without true chronic asthma


- Unstable asthma requiring immediate emergency care All patients with asthma
exacerbations will receive usual urgent or emergency care for asthma and must be
improving or stable in the judgment of the treating physician prior to being enrolled


- Specified co-morbidities likely to interfere with study assessments or follow up.
Excluded comorbidities include:


- cystic fibrosis


- obstructive sleep apnea requiring CPAP


- cardiomyopathy


- congestive heart failure


- terminal cancer


- alcohol or other drug abuse


- or any other serious medical condition that, in the opinion of the study
physician, would seriously interfere with or preclude assessment of study
outcomes or completion of study assessments


- Specified medical conditions for which macrolide administration may possibly be
hazardous


- Patients with acute or chronic hepatitis, cirrhosis or other liver disease, chronic
kidney disease, or history of prolonged cardiac repolarization and QT interval or
torsades de pointes, are excluded


- Specified medications for which close monitoring has been recommended in the setting
of macrolide administration Patients taking digoxin, theophylline, warfarin,
ergotamine or dihydroergotamine, triazolam, carbamazepine, cyclosporine, hexobarbital
or phenytoin are excluded.


- If any of these medications are started after randomization and before completion
of the 12-week treatment phase, study medication will be discontinued and the
patient may remain in the study.


The intent of this protocol is to enroll a broadly generalizable sample of adult patients
with physician-diagnosed asthma, either stable persistent or in exacerbation.

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Advanced Information
Descriptive Information
Brief Title  ICMJE AZMATICS: AZithroMycin/Asthma Trial In Community Settings
Official Title  ICMJE AZMATICS: Azithromycin Asthma Trial In Community Settings
Brief Summary

The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma.

Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma?

Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers.

Active study sites -

  • Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison,
  • Mauston, Rice Lake, Tomah, Wausau
  • Colorado: Monument
  • Illinois: Peoria
  • Nevada: Reno
  • North Carolina: Granite Falls
  • North Dakota: Minot
  • Ohio: Cleveland, Berea
  • Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford
  • Rhode Island: East Providence
Detailed Description

1.0 PROTOCOL SYNOPSIS

Approximately 100 eligible adult patients with physician-diagnosed asthma will either be randomized to 12-week treatment with azithromycin or an identical placebo, or join an observational open-label azithromycin cohort. Azithromycin is a widely marketed azalide antibiotic with an excellent safety profile. Azithromycin or placebo will be adjunctive therapy for usual asthma care. The following patient-reported data will be collected via Zoomerang? (a commercially-available data collection tool) periodically until one year after randomization: (1) study medication adherence and side effects weekly until 12 weeks, (2) asthma control and exacerbations every 6 weeks until 12 months, and (3) asthma quality of life and asthma controller medication changes every 3 months until 12 months. The primary hypothesis is that azithromycin will significantly improve asthma control (decrease symptoms and medication use) by 3 months (end treatment) and the improvement will continue to 12 months (end study). The primary outcome variable is overall asthma symptoms. Secondary outcomes are asthma medication use, quality of life and exacerbations. We will examine the predictive value of baseline patient characteristics including age, sex, smoking, co-morbid respiratory diagnoses and degree of airflow limitation. We will also examine for any imbalances between study groups in controller medication use, other antibiotic prescriptions and acute respiratory illnesses during the one-year study period.

We will enroll subjects from the practices of Wisconsin Research and Education Network (WREN) members, UW Department of Family Medicine physicians, Dean Medical Center primary care physicians, and from other practice-based research networks (PBRNs), medical group practices and individual primary care practices throughout North America.

Patients with physician-diagnosed asthma aged 18 and older will be identified at point-of-service (office, urgent care, emergency room or hospital), by administrative data base review, or by physician recall. Most subjects will be the patients of study physicians. Other physicians in the group practice may refer subjects. Subjects also may be self-referred after responding to posters placed in the clinics. Some sites may elect to identify cases by medical record or database review, in which case only the personal physician may initiate patient contacts.

Treatment is azithromycin tablets, 600 milligrams orally once daily for 3 days, then 600 milligrams once weekly for an additional 11 weeks (total dose 8400 milligrams) or identical placebo, in addition to usual care for asthma.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2 arms are randomized, placebo-controlled, double-blinded, 1 arm was added as an open-label observational cohort
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Azithromycin
    600 mg x 3 days, then 600 mg weekly x 11 weeks
    Other Name: Zithromax
  • Drug: Placebo
    Matching placebo
Study Arms  ICMJE
  • Active Comparator: Azithromycin
    Active adjunctive treatment
    Intervention: Drug: Azithromycin
  • Placebo Comparator: Placebo
    Adjunctive placebo
    Intervention: Drug: Placebo
  • Observational Cohort
    Eligible participants who declined randomization, offered enrollment in parallel, open-label azithromycin treatment arm
    Intervention: Drug: Azithromycin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2011)
97
Original Enrollment  ICMJE
 (submitted: December 15, 2005)
600
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 and older (and at least 50 kg/110 pounds)

    • The lower weight limit was chosen to avoid exposure to greater than 12 mg/kg/day of azithromycin (a currently recommended dose for children)
    • We specify no upper age limit because asthma occurs throughout the age range and because asthma in the elderly is particularly severe and warrants inclusion.
  • Physician-diagnosed asthma
  • At the time of randomization, eligible subjects must either:

    • be having a documented asthma exacerbation OR
    • be reporting at least mild persistent asthma symptoms, as defined by GINA (Global Initiative for Asthma)
  • Subjects must also have asthma symptoms for at least six months prior to randomization
  • Documentation of objective evidence of reversible airway obstruction, either spontaneously or after treatment, is required prior to randomization. This requirement can be met by documentary evidence, within 2 years of randomization, of either:

    • a 12% or greater (and ?200 mL) change in FEV1 OR
    • a 25% or greater (and >60 L/min) change in PEFR either spontaneously or as a result of treatment

Exclusion Criteria:

  • Not English literate or without email and internet access
  • Macrolide allergy
  • Pregnancy or lactation
  • Females of childbearing potential must agree to use an acceptable form of contraception during the treatment period
  • Chronic use of macrolides, tetracyclines or quinolones Chronic use is defined as 4 or more weeks of continuous use within 6 months of randomization
  • Asthma symptoms for less than 6 months prior to randomization Asthma symptoms must be present for at least 6 months to exclude patients without true chronic asthma
  • Unstable asthma requiring immediate emergency care All patients with asthma exacerbations will receive usual urgent or emergency care for asthma and must be improving or stable in the judgment of the treating physician prior to being enrolled
  • Specified co-morbidities likely to interfere with study assessments or follow up. Excluded comorbidities include:

    • cystic fibrosis
    • obstructive sleep apnea requiring CPAP
    • cardiomyopathy
    • congestive heart failure
    • terminal cancer
    • alcohol or other drug abuse
    • or any other serious medical condition that, in the opinion of the study physician, would seriously interfere with or preclude assessment of study outcomes or completion of study assessments
  • Specified medical conditions for which macrolide administration may possibly be hazardous
  • Patients with acute or chronic hepatitis, cirrhosis or other liver disease, chronic kidney disease, or history of prolonged cardiac repolarization and QT interval or torsades de pointes, are excluded
  • Specified medications for which close monitoring has been recommended in the setting of macrolide administration Patients taking digoxin, theophylline, warfarin, ergotamine or dihydroergotamine, triazolam, carbamazepine, cyclosporine, hexobarbital or phenytoin are excluded.

    • If any of these medications are started after randomization and before completion of the 12-week treatment phase, study medication will be discontinued and the patient may remain in the study.

The intent of this protocol is to enroll a broadly generalizable sample of adult patients with physician-diagnosed asthma, either stable persistent or in exacerbation.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00266851
Other Study ID Numbers  ICMJE H-2005-0258
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE
  • American Academy of Family Physicians
  • Dean Foundation
  • Pfizer
Investigators  ICMJE
Principal Investigator:David L Hahn, MD, MSWisconsin Research and Education Network (WREN)
PRS Account University of Wisconsin, Madison
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP