Macrolides to Prevent Exacerbations of Asthma and Chronic Obstructive Pulmonary Disease

NCT00181272 | Terminated Phase 2

• 1 other identifier: 05-02-17-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease (COPD); undifferentiated asthma/COPD

Outcome Measures

Primary Outcomes (1)

• The effect of azithromycin on the rate of exacerbations for asthma or COPD exacerbations after hospital discharge

Secondary Outcomes (4)

• changes in airflow obstruction (FEV1% predicted)

• serum biomarkers of airway inflammation (IL-1beta, IL-5, IL-6, IL-8, IL-10, RANTES, IFN-gamma, TNF-alpha, and hs-CRP)

• respiratory markers of inflammation (EBC measurements - pH)

• symptom/quality of life measures

Interventions

azithromycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Jerry A Krishnan, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

US (1)