Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Effect of Chronic Macrolide Administration on the Frequency and Severity of COPD Exacerbations
Verified date | October 2019 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if long-term administration of a macrolide antibiotic will reduce worsening of symptoms among individuals with chronic obstructive pulmonary disease (COPD).
Status | Completed |
Enrollment | 1142 |
Est. completion date | July 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of at least moderate Chronic Obstructive Pulmonary Disease (COPD), as defined by the following Global Initiative for COPD (GOLD) criteria: 1. Post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than 70% 2. Post-bronchodilator FEV1 less than 80% predicted, with or without chronic symptoms - Cigarette consumption of 10 pack-years or more (may or may not be active smokers) - Meets one or more of the following four conditions: 1. Current, or history of, supplemental O2 use 2. Received a course of systemic corticosteroids for respiratory problems within 1 year prior to study entry 3. Visited an emergency department for a COPD exacerbation within 1 year prior to study entry 4. Hospitalized for a COPD exacerbation within 1 year prior to study entry - Willing to make return visits - Available by telephone for duration of study - Minimum of 4 weeks from the most recent acute exacerbation (have not received a course of systemic corticosteroids, an increased dose of chronically administered systemic corticosteroids, and/or antibiotics for an acute exacerbation for a minimum of 4 weeks from the time of study entry) Exclusion Criteria: - Diagnosis of asthma - Diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy less than 3 years - Special patient groups (i.e., prisoners, pregnant women, or institutionalized patients) - Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (i.e., hormone-based oral or barrier contraceptive) for the duration of the study - History of hypersensitivity to any macrolide antibiotic - Taking any of the following medications: 1. Cisapride 2. Ergot derivatives 3. Pimozide 4. Disopyramide 5. Cyclosporin 6. Tacrolimus 7. Nelfinavir 8. Bromocriptine 9. Hexobarbital - Corrected QT interval (QTc) on electrocardiogram exceeding 440 ms - Taking rifabutin or rifampin - Chronic hepatic insufficiency - Chronic renal insufficiency - Diagnosis of bronchiectasis (defined as production of greater than one-half cup of purulent sputum/day) - If, for either ear, formal audiometric testing in a sound booth results in a pure tone average (i.e., the average of the thresholds for the 4 frequencies 1000, 2000, 3000, or 4000) exceeding 50 decibel (dB), or if the threshold at any one frequency exceeds 60 dB, then the participant will be counseled by the audiologist concerning hearing aids and/or referral to an otolaryngologist. In addition, the audiologist may discuss with the participant whether or not to continue in the study. Following the examination and counseling, the participant will also discuss whether or not to continue in the study with one of the study investigators. If it is found that a participant's pure tone average in the two ears differs by more than 15 dB, or if the difference in the two ears for any one frequency exceeds 20 dB, then the participant will not be eligible for randomization into the study unless cleared by an otolaryngologist |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Maryland Baltimore | Baltimore | Maryland |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Denver City-County Health/Hospitals Dept. | Denver | Colorado |
United States | Minnesota Veterans Research Inst. | Minneapolis | Minnesota |
United States | Temple University | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | University of California at San Francisco | San Francisco | California |
United States | Harbor-UCLA Research & Education Inst. | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Time until first occurrence of acute Chronic Obstructive Pulmonary Disease (COPD) exacerbation. Acute exacerbations are defined as a "complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids " | Measured monthly through 13 months | |
Secondary | Exacerbations/Patient Year | Acute exacerbations are defined as a "complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids " | Measured monthly until 13 months | |
Secondary | Number of Emergency Department Visits as a Result of Acute Exacerbations | Measured monthly for 12 months | ||
Secondary | Number of Hospital Admissions as a Result of Acute Exacerbations | Measured monthly for 12 months | ||
Secondary | Change in Age-adjusted Hearing Threshold | Assessed by audiometry for four sound frequencies (1000, 2000, 3000, 4000 Hz). The maximum was computed for each threshold in each ear for all frequencies, then the differences between visits were assessed. | Baseline and 12 months | |
Secondary | Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum | Cultures from 68% of the participants in the azithromycin group and 70% in the placebo group who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization. | Baseline | |
Secondary | Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum | Cultures from some participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization. | During Course of Study (either month 3, 6, 9, or 12) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05043428 -
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
|
N/A | |
Completed |
NCT00528996 -
An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
|
Phase 2 | |
Completed |
NCT03740373 -
A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate
|
Phase 1 | |
Completed |
NCT05393245 -
Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
|
||
Completed |
NCT05402020 -
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
|
||
Completed |
NCT04011735 -
Re-usable Respimat® Soft MistTM Inhaler Study
|
||
Enrolling by invitation |
NCT03075709 -
The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
|
||
Completed |
NCT03764163 -
Image and Model Based Analysis of Lung Disease
|
Early Phase 1 | |
Completed |
NCT00515268 -
Endotoxin Challenge Study For Healthy Men and Women
|
Phase 1 | |
Completed |
NCT04085302 -
TARA Working Prototype Engagement Evaluation: Feasibility Study
|
N/A | |
Completed |
NCT03691324 -
Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
|
N/A | |
Completed |
NCT02236611 -
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT00153075 -
Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT01017952 -
A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT01009463 -
A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT04882124 -
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
|
Phase 2 | |
Completed |
NCT02853123 -
Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients
|
Phase 4 | |
Completed |
NCT02619357 -
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
|
Phase 1 | |
Recruiting |
NCT05858463 -
High Intensity Interval Training and Muscle Adaptations During PR
|
N/A | |
Not yet recruiting |
NCT05032898 -
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
|