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Trial record 29 of 43 for:    "Bronchial Disease" | "Azithromycin"

Macrolides to Prevent Exacerbations of Asthma and Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00181272
Recruitment Status : Terminated (Principal Investigator moved institutions)
First Posted : September 16, 2005
Last Update Posted : May 13, 2013
Information provided by (Responsible Party):
Jerry A. Krishnan, Johns Hopkins University

Brief Summary:
The purpose of this study is to determine whether macrolide therapy is effective in treating patients hospitalized with asthma exacerbations or chronic obstructive pulmonary disease (COPD)exacerbations. We hypothesize that compared to placebo, maintenance therapy with macrolides, when added to usual care, a) improves respiratory symptoms, b) improves quality of life, c) reduces airway inflammation, d) reduces airflow obstruction, and e) decreases the rate of re-exacerbations.

Condition or disease Intervention/treatment Phase
Asthma Chronic Obstructive Pulmonary Disease Drug: azithromycin Phase 2

Detailed Description:
Asthma and chronic obstructive pulmonary disease (COPD) are the two most common obstructive lung diseases. Chronic airway inflammation and episodic worsening of respiratory symptoms and airflow obstruction (exacerbations) occur in asthma and COPD. Despite major advances in the development of therapies for these respiratory disorders, asthma and COPD exacerbations are common and result in substantial morbidity and mortality. Moreover, patients hospitalized for asthma or COPD exacerbations are at high risk for near fatal and fatal re-exacerbations after discharge home. These observations highlight the need for novel therapies to prevent asthma and COPD exacerbations. The role of macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin) in treating bacterial infections is well established. Recent pre-clinical evidence also suggests that macrolides may posses distinct anti-inflammatory properties and even anti-viral properties. These exciting observations have led to research evaluating the use of maintenance therapy with macrolides in patients with asthma and COPD. Small studies in clinically stable asthma or COPD suggest that maintenance macrolide therapy (e.g., use for 6 weeks), when added to usual care, may attenuate airway inflammation, reduce respiratory symptoms, and improve lung function. However, there are no studies that have evaluated the potential benefits of initiating maintenance macrolide therapy during asthma or COPD exacerbations. We hypothesize that initiating maintenance macrolide therapy in hospitalized patients with asthma or COPD exacerbations will, when added to usual medical care, accelerate the improvement in airflow obstruction, respiratory symptoms, and quality of life and reduce the risk of re-exacerbations after discharge home. The objective of this pilot study is to evaluate the feasibility of the study protocol (recruitment, retention, and adherence to study procedures and medications), as well as collect preliminary data about the proportion of exacerbations due to bacterial or viral infections and estimate potential effect sizes for clinically important outcomes (respiratory symptoms, quality of life, airflow obstruction, airway inflammation, and rate of re-exacerbations). To achieve these objectives, we propose a 48 week randomized, double-blind, placebo-controlled crossover clinical trial (24 weeks azithromycin, 24 weeks placebo) in adults hospitalized for asthma or COPD exacerbations to the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Macrolides to Prevent Exacerbations of Asthma and Chronic Obstructive Pulmonary Disease
Study Start Date : September 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The effect of azithromycin on the rate of exacerbations for asthma or COPD exacerbations after hospital discharge

Secondary Outcome Measures :
  1. changes in airflow obstruction (FEV1% predicted)
  2. serum biomarkers of airway inflammation (IL-1beta, IL-5, IL-6, IL-8, IL-10, RANTES, IFN-gamma, TNF-alpha, and hs-CRP)
  3. respiratory markers of inflammation (EBC measurements - pH)
  4. symptom/quality of life measures

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Physician-diagnosis of asthma, COPD exacerbation, or undifferentiated asthma/COPD exacerbation
  • Admitted to the inpatient medical service at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center
  • Evidence of airflow obstruction on spirometry (FEV1/FVC<70%)
  • Age 18 years or older

Exclusion Criteria:

  • History of allergy or other contraindication to macrolides (azithromycin, erythromycin, clarithromycin)
  • Treatment with any macrolide in the 4 weeks prior to study entry
  • Elevated AST or ALT (2 or more times the upper limit of normal) on current admission
  • Elevated alkaline phosphatase (>1.25 times the upper limit of normal) on current admission
  • Elevated total serum bilirubin (more than upper limit of normal) on current admission
  • Previous participation in this study
  • Patients prescribed digoxin (azithromycin may increase digoxin levels)
  • Patients prescribed warfarin (azithromycin may increase INR in patients on warfarin)
  • Patients prescribed pimozide (azithromycin may increase risk of arrhythmias)
  • Patient unable to provide consent (e.g., language difficulty or history of dementia)
  • Patient to be discharged to a location other than home (e.g., other hospital, long-term care facility)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00181272

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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Jerry A Krishnan, MD, PhD Johns Hopkins University

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Responsible Party: Jerry A. Krishnan, Associate Professor, Johns Hopkins University Identifier: NCT00181272     History of Changes
Other Study ID Numbers: 05-02-17-01
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013

Keywords provided by Jerry A. Krishnan, Johns Hopkins University:
chronic obstructive pulmonary disease (COPD)
undifferentiated asthma/COPD

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases