AZMATICS: AZithroMycin/Asthma Trial In Community Settings

NCT00266851 | Completed Phase 3 Results DMC

• 1 other identifier: H-2005-0258
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 5

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

Conditions

Asthma

Keywords

Randomized clinical trial; Asthma; Adults; Azithromycin

Outcome Measures

Primary Outcomes (1)

• Change in Overall Asthma Symptoms From Baseline

  5-point scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=worst ever, the lower scores indicate improvement in asthma symptoms

  Within the past 24 hours; measured every 1.5 months for one year

Secondary Outcomes (3)

• Change in Asthma Control Over Baseline

  Within the past week; every 3 months

• Change is Asthma-specific Quality-of-Life (AQL)

  Within the past 2 weeks; every three months

• Asthma Exacerbations

  up to 12 months

Study Arms (3)

Azithromycin

ACTIVE COMPARATOR

Active adjunctive treatment

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

Adjunctive placebo

Drug: Placebo

Observational Cohort

OTHER

Eligible participants who declined randomization, offered enrollment in parallel, open-label azithromycin treatment arm

Drug: Azithromycin

Interventions

Azithromycin DRUG

600 mg x 3 days, then 600 mg weekly x 11 weeks

Also known as: Zithromax

Azithromycin; Observational Cohort

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• American Academy of Family Physicians: collaborator
• Dean Foundation: collaborator
• Pfizer: collaborator

Study Sites (5)

ANSR

Peoria, Illinois, 61602, United States

Location

AAFP National Research Network

Kansas City, Kansas, 66211, United States

Location

RAP - Cleveland Clinic

Cleveland, Ohio, 44130, United States

Location

University of Oklahoma Health Sciences Center (OUHSC) and Oklahoma Physicians Resource/Research Network (OKPRN)

Oklahoma City, Oklahoma, 73104, United States

Location

Wisconsin Research and Education Network (WREN)

Madison, Wisconsin, 53713, United States

Location

Related Publications (5)

• 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: 15226283 BACKGROUND

• Hahn DL. Treatment of Chlamydia pneumoniae infection in adult asthma: a before-after trial. J Fam Pract. 1995 Oct;41(4):345-51.

  PMID: 7561707 BACKGROUND

• Hahn DL. Chlamydia pneumoniae, asthma, and COPD: what is the evidence? Ann Allergy Asthma Immunol. 1999 Oct;83(4):271-88, 291; quiz 291-2. doi: 10.1016/S1081-1206(10)62666-X.

  PMID: 10541419 BACKGROUND

• Hahn DL, Plane MB, Mahdi OS, Byrne GI. Secondary outcomes of a pilot randomized trial of azithromycin treatment for asthma. PLoS Clin Trials. 2006 Jun;1(2):e11. doi: 10.1371/journal.pctr.0010011. Epub 2006 Jun 30.

  PMID: 16871333 BACKGROUND

• Hahn DL, Grasmick M, Hetzel S, Yale S; AZMATICS (AZithroMycin-Asthma Trial In Community Settings) Study Group. Azithromycin for bronchial asthma in adults: an effectiveness trial. J Am Board Fam Med. 2012 Jul-Aug;25(4):442-59. doi: 10.3122/jabfm.2012.04.110309.

  PMID: 22773713 RESULT

Related Links

• Patient perspective/literature review
• Book that reviews the topic of infection as a treatable cause for asthma

MeSH Terms

Conditions

Asthma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dr. David Hahn
• Organization: Wisconsin Resaerch & Education Network

dlhahn@wisc.edu

608-234-3212

Study Officials

• David L Hahn, MD, MS

  Wisconsin Research and Education Network (WREN)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arms are randomized, placebo-controlled, double-blinded, 1 arm was added as an open-label observational cohort

Study Record Dates

• First Submitted: December 15, 2005
• First Posted: December 19, 2005
• Study Start: January 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)