Asthma and Chlamydia Pneumoniae Link Says Study from Massachusetts University
Recent press reports and research reflect that American researchers have recently linked a particular type of bacteria, Chlamydia pneumoniae, with very bad cases of the respiratory condition and Asthma. Chlamydia pneumoniae is not related to a sexually transmitted disease.
The Chlamydia pneumoniae (C. pneumoniae) organism, first described in 1988, is not the sexually-transmitted type that first comes to mind to most people. It is an airborne organism that you get from breathing after a person carrying the organism has coughed.
“They float around as droplet nuclei, similar to TB. People cough and up come these infectious bodies. They float around a room. You breathe. In they come and now you’ve got your own.”
Eduard Drizik, a microbiologist at Massachusetts University in the US, led the study which looked at whether the presence of antibodies specific to fighting C. pneumonia could predict the severity of a patient’s asthma.
Video Microbiology: Chlamydia and Asthma Courtesy of the Amereican Society of Microbiology
Presenting the study to the annual conference of the American Society for Microbiology in New Orleans on Monday, Drizik said: “We conclude that a subset of severe asthmatics harbor infectious C. pneumoniae in their lungs, resulting in antibody production and increased asthma severity.”
He explained: “Of the asthma patients analysed, 55 per cent had Chlamydia-specific antibodies in their lungs compared to 12 per cent of blood donor controls.”
The University of Wisconsin, Madison recently concluded a clinical trial entitled “AZMATICS: AZithroMycin/Asthma Trial In Community Settings” and the results are pending.
Patients with severe asthma who were treated with antibiotics saw their symptoms significantly improve, while in some they completely disappeared.
Drizik said doctors “should therefore fully explore the involvement of microbes in difficult to treat asthma cases, since there might be a cure for some types of asthma after all”.
The study comes after work which found that asthma can be caused by chronic inflammation.
Inflammation is often a sign of infection, which has led microbiologists to search for potential bacterial culprits.
Related News
Clinical Trial Information
AZMATICS: AZithroMycin/Asthma Trial In Community Settings
This study has been completed.
First Received on December 15, 2005. Last Updated on April 12, 2011 History of Changes
Sponsor: University of Wisconsin, Madison
Collaborators:
American Academy of Family Physicians
Wisconsin Academy of Family Physicians (WAFP)
Dean Foundation
Pfizer
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00266851
Purpose
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) 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
Condition Intervention Phase
Asthma
Drug: Azithromycin
Drug: Placebo
Phase III
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AZMATICS: Azithromycin Asthma Trial In Community Settings
Resource links provided by NLM:
MedlinePlus related topics: Asthma
Drug Information available for: Azithromycin
U.S. FDA Resources
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
Overall asthma symptoms, as measured by a 5-point scale [ Time Frame: 2006-2010 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Asthma control [ Time Frame: 2006-2010 ] [ Designated as safety issue: No ]
Asthma-specific quality-of-life [ Time Frame: 2006-2010 ] [ Designated as safety issue: No ]
Asthma exacerbations [ Time Frame: 2006-2010 ] [ Designated as safety issue: No ]
Enrollment: 97
Study Start Date: January 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Azithromycin: Active Comparator
Active adjunctive treatment
Intervention: Drug: Azithromycin
Drug: Azithromycin
600 mg x 3 days, then 600 mg weekly x 11 weeks
Other Name: Zithromax
Placebo: Placebo Comparator
Adjunctive placebo
Intervention: Drug: Placebo
Drug: Placebo
Matching placebo
Detailed Description:
1.0 PROTOCOL SYNOPSIS
Approximately 100 eligible adult patients with physician-diagnosed asthma will be randomized to 12-week treatment with azithromycin, a widely marketed azalide antibiotic with an excellent safety profile, or identical placebo as adjunctive therapy for usual care for asthma. 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.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266851
Locations
United States, Illinois
ANSR
Peoria, Illinois, United States, 61602
United States, Kansas
AAFP National Research Network
Kansas City, Kansas, United States, 66211
United States, Ohio
RAP – Cleveland Clinic
Cleveland, Ohio, United States, 44130
United States, Oklahoma
University of Oklahoma Health Sciences Center (OUHSC) and Oklahoma Physicians Resource/Research Network (OKPRN)
Oklahoma City, Oklahoma, United States, 73104
United States, Wisconsin
Wisconsin Research and Education Network (WREN)
Madison, Wisconsin, United States, 53713
Sponsors and Collaborators
University of Wisconsin, Madison
American Academy of Family Physicians
Wisconsin Academy of Family Physicians (WAFP)
Dean Foundation
Pfizer
Investigators
Principal Investigator: David L Hahn, MD, MS Wisconsin Research and Education Network (WREN)
More Information
Additional Information:
Patient perspective/literature review This link exits the ClinicalTrials.gov site
Infectious asthma research/annotated bibliography This link exits the ClinicalTrials.gov site
Publications:
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.
Hahn DL. Treatment of Chlamydia pneumoniae infection in adult asthma: a before-after trial. J Fam Pract. 1995 Oct;41(4):345-51.
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. Review.
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. Epub 2006 Jun 30.
Responsible Party: Dean Medical Center ( David L Hahn )
ClinicalTrials.gov Identifier: NCT00266851 History of Changes
Other Study ID Numbers: H-2005-0258
Study First Received: December 15, 2005
Last Updated: April 12, 2011
Health Authority: United States: Institutional Review Board
Keywords provided by University of Wisconsin, Madison:
Randomized clinical trial
Asthma
Adults
Azithromycin
Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
ClinicalTrials.gov processed this record on June 30, 2011
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