COPD Research at the COPD Research at the University of Maryland University of Maryland

School of MarylandSchool of Maryland

COPD Clinical Research CenterCOPD Clinical Research CenterA member of the National Heart Lung & Blood InstituteA member of the National Heart Lung & Blood Institute

National Institutes of HealthNational Institutes of Health

Director: Steven M. Scharf, MD, PhDDirector: Steven M. Scharf, MD, PhD

What is COPD?What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease

It causes inflammation in the lung

COPD can be from chronic bronchitis or from emphysema

The primary causes of COPD are:The primary causes of COPD are: Environmental exposure to harmful Environmental exposure to harmful

agentagent Exposure of time to cigarette smokeExposure of time to cigarette smoke

COPD – Chronic COPD – Chronic BronchitisBronchitis

In chronic bronchitis, the In chronic bronchitis, the tubes through which air tubes through which air moves in and out of the moves in and out of the lungs become swollen lungs become swollen and fill with mucus. and fill with mucus.

This swelling and mucus This swelling and mucus obstructs, or slows, the obstructs, or slows, the flow of air in and out of flow of air in and out of the lungs. the lungs. Mucus

COPD - EmphysemaCOPD - Emphysema

In emphysema, the In emphysema, the little air sacs little air sacs (called alveoli) at (called alveoli) at the end of the the end of the airways are airways are damaged.damaged.

When the air sacs are damaged, they lose their ability to push air out of the lungs.

Signs and Symptoms of Signs and Symptoms of COPDCOPD

Severe shortness of breath with Severe shortness of breath with no or just mild effortno or just mild effort

Cough and sputum production - Cough and sputum production - repeated pulmonary infectionsrepeated pulmonary infections

Over-inflation of the lungsOver-inflation of the lungs Low oxygen levels/high carbon Low oxygen levels/high carbon

dioxide levels in the blooddioxide levels in the blood Poor sleep qualityPoor sleep quality Depression/anxietyDepression/anxiety Loss of muscle mass, weakness, Loss of muscle mass, weakness,

poor muscle tonepoor muscle tone Heart FailureHeart Failure

Current Treatments for Current Treatments for COPDCOPD

Today, doctors have three choices for Today, doctors have three choices for daily treatment of COPD:daily treatment of COPD:

BronchodilatorsBronchodilators CorticosteroidsCorticosteroids Oxygen TherapyOxygen Therapy

Today, doctors have three choices for Today, doctors have three choices for daily treatment of COPD:daily treatment of COPD:

BronchodilatorsBronchodilators CorticosteroidsCorticosteroids Oxygen TherapyOxygen Therapy

Current Treatment – Current Treatment – Bronchodilators Bronchodilators

Bronchodilators relax the Bronchodilators relax the muscles that narrow the muscles that narrow the airways in the lungs. airways in the lungs.

Relaxing these muscles Relaxing these muscles helps to make the airway helps to make the airway larger. larger.

When the airways are larger When the airways are larger it is easier for air to move in it is easier for air to move in and out of the lungs. and out of the lungs.

Corticosteroids decrease Corticosteroids decrease the swelling and the swelling and inflammation in the airways inflammation in the airways of the lungs. of the lungs.

With less swelling, the With less swelling, the airways stay open and air airways stay open and air moves in and out bettermoves in and out better..

Current Treatment – Current Treatment – Corticosteroids Corticosteroids

Current Treatment – Oxygen Current Treatment – Oxygen TherapyTherapy

When lungs are severely damaged When lungs are severely damaged by COPD, they are not able to move by COPD, they are not able to move enough oxygen from the air into the enough oxygen from the air into the blood. blood.

When this happens, the amount of When this happens, the amount of oxygen in the blood drops making oxygen in the blood drops making breathing harder.breathing harder.

Oxygen therapy increases the Oxygen therapy increases the amount of oxygen a person amount of oxygen a person breathes in. breathes in.

This helps return the amount of This helps return the amount of oxygen in the blood to normal and oxygen in the blood to normal and make breathing easier. make breathing easier.

COPD Research at the COPD Research at the University of Maryland School University of Maryland School

of Medicineof Medicine COPD research is conducted in an effort COPD research is conducted in an effort

to identify therapies that will help COPD to identify therapies that will help COPD patients better manage their disease. patients better manage their disease.

The research at University of Maryland The research at University of Maryland School of Medicine is led by researchers School of Medicine is led by researchers in the COPD Clinical Research Center in the COPD Clinical Research Center and the University of Maryland Airways and the University of Maryland Airways Research Center. Research is funded by Research Center. Research is funded by federal agencies as well as industry federal agencies as well as industry sponsors.sponsors.

Long-term Oxygen Treatment TrialLong-term Oxygen Treatment Trial (Currently recruiting)(Currently recruiting) – funded by the – funded by the National Heart Lung & Blood InstituteNational Heart Lung & Blood Institute

STATCOPE StudySTATCOPE Study (Currently recruiting)(Currently recruiting) – – funded by the National Heart Lung & Blood funded by the National Heart Lung & Blood InstituteInstitute

Fluticasone StudyFluticasone Study (Not yet recruiting)(Not yet recruiting) – – funded by Glaxo Smith Kline, Inc.funded by Glaxo Smith Kline, Inc.

Aclidinium Bromide StudyAclidinium Bromide Study (Recruitment (Recruitment Completed)Completed) – funded by Forrest Laboratories, – funded by Forrest Laboratories, Inc.Inc.

Previous StudiesPrevious Studies

COPD Research at the COPD Research at the University of Maryland School University of Maryland School

of Medicineof Medicine

Long-term Oxygen Treatment Long-term Oxygen Treatment TrialTrial

(LOTT) Study – Currently (LOTT) Study – Currently RecruitingRecruiting

Under current Medicare guidelines, Under current Medicare guidelines, patients with COPD who have moderately patients with COPD who have moderately low levels of oxygen in their blood do not low levels of oxygen in their blood do not qualify for supplemental oxygen.qualify for supplemental oxygen.

The LOTT Study is funded by the National The LOTT Study is funded by the National Heart Lung & Blood Institute. The purpose Heart Lung & Blood Institute. The purpose of this study is to help researchers of this study is to help researchers understand if oxygen therapy is helpful for understand if oxygen therapy is helpful for COPD patients with moderately low levels COPD patients with moderately low levels of oxygen in their blood at rest or very low of oxygen in their blood at rest or very low blood oxygen during exercise. blood oxygen during exercise.

The STATCOPE study is funded by The STATCOPE study is funded by the National Heart Lung & Blood the National Heart Lung & Blood Institute and is being conducted to Institute and is being conducted to determine if an FDA approved determine if an FDA approved statin drug called simvastatin statin drug called simvastatin might reduce swelling in the lungs might reduce swelling in the lungs in patients with COPD. in patients with COPD.

If it is found that this statin drug If it is found that this statin drug reduces lung inflammation, there reduces lung inflammation, there is a possibility that the statin drug is a possibility that the statin drug could also limit the number or the could also limit the number or the severity of flare-ups, called severity of flare-ups, called exacerbations, in patients with exacerbations, in patients with COPD. COPD.

STATCOPE Study – Currently STATCOPE Study – Currently RecruitingRecruiting

The Fluticasone Study is funded by Glaxo Smith Kline, Inc., and The Fluticasone Study is funded by Glaxo Smith Kline, Inc., and will test the effect of a combination of two experimental drugs, will test the effect of a combination of two experimental drugs, fluticasone furoate (FF) (an inhaled corticosteroid) and fluticasone furoate (FF) (an inhaled corticosteroid) and GW642444 (a bronchodilator) in people with COPD. GW642444 (a bronchodilator) in people with COPD.

The combination of these two drugs is called FF/GW642444. The combination of these two drugs is called FF/GW642444.

FF/GW642444 is an investigational drug being studied for use FF/GW642444 is an investigational drug being studied for use in people with COPD and asthma. in people with COPD and asthma. This research study will try to answer questions about study This research study will try to answer questions about study

drug FF/GW642444:drug FF/GW642444: Does it help people with COPD feel better?Does it help people with COPD feel better? How safe is it for people to take?How safe is it for people to take? Does it make it easier to breathe?Does it make it easier to breathe? What is its effect on the rate of exacerbations (your COPD What is its effect on the rate of exacerbations (your COPD

symptoms get worse) in people with COPD over a one-year symptoms get worse) in people with COPD over a one-year dosing period? dosing period?

Are there any reported cases of pneumonia?Are there any reported cases of pneumonia?

Fluticasone Study – Fluticasone Study – Not Yet Not Yet RecruitingRecruiting

1.1. See how well the study drug works to See how well the study drug works to open up the airways in patients with open up the airways in patients with moderate to severe COPD. moderate to severe COPD.

2.2. Find out if the study drug helps prevent Find out if the study drug helps prevent COPD symptoms from getting worse.COPD symptoms from getting worse.

3.3. Assess if the study drug affects the Assess if the study drug affects the COPD patient’s health status, in general COPD patient’s health status, in general and as related to the lung disease.and as related to the lung disease.

4.4. Look at the safety of two doses of the Look at the safety of two doses of the study drug, 200 micrograms and 400 study drug, 200 micrograms and 400 micrograms, taken twice daily as micrograms, taken twice daily as compared with a placebo (an inactive compared with a placebo (an inactive substance).substance).

Aclidinium Bromide Study – Aclidinium Bromide Study – Recruitment CompletedRecruitment Completed

This study is funded by Forest Laboratories, Inc., and will test a This study is funded by Forest Laboratories, Inc., and will test a new inhaled bron- chodilator called Aclidinium Bromide. The new inhaled bron- chodilator called Aclidinium Bromide. The purposes of this study are to:purposes of this study are to:

Previous StudiesPrevious Studies

Pneumonia Vaccine Study – funded by National Pneumonia Vaccine Study – funded by National Heart Lung & Blood InstituteHeart Lung & Blood Institute This study compared the effectiveness of the FDA This study compared the effectiveness of the FDA

approved pediatric pneumonia vaccine (Prevnar) with the approved pediatric pneumonia vaccine (Prevnar) with the approved adult version of the vaccine (Pneumovax) in approved adult version of the vaccine (Pneumovax) in patients with COPD.patients with COPD.

Macrolide Study - funded by National Heart Macrolide Study - funded by National Heart Lung & Blood InstituteLung & Blood Institute This study involved the long-term use of an FDA approved This study involved the long-term use of an FDA approved

Macrolide antibiotic called Azithromycin on COPD Macrolide antibiotic called Azithromycin on COPD exacerbations in patients with moderate to severe COPDexacerbations in patients with moderate to severe COPD

Participating in COPD at Participating in COPD at University of MarylandUniversity of Maryland

If you are interested in participating in COPD research at the If you are interested in participating in COPD research at the

University of Maryland or interested in learning more, contact the:University of Maryland or interested in learning more, contact the:

COPD Clinical Research Center at COPD Clinical Research Center at 410-706-3355, the University of 410-706-3355, the University of

Maryland Airways Research Center Maryland Airways Research Center at 410-706-LUNG (5864)at 410-706-LUNG (5864)