5 things to know about COPD Clinical Trials

If you or a loved one has been diagnosed with Chronic Obstructive Pulmonary Disease (COPD), it’s important to know what to expect and what you can do about it. Though there is no cure for COPD, there have been some recent advancements and ongoing clinical trials that are trying to make the disease more treatable. 

This article looks at what COPD is, what causes it, how you can prevent and treat the disease, as well as some of the most recent scientific findings. Plus, we’ll go over what clinical trials are and how you can find to join.

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1. What is COPD?

Chronic Obstructive Pulmonary Disease is a long-term inflammatory lung disease that causes difficulty breathing, coughing, wheezing, and mucous build-up in the airways. This airway obstruction and inflammation can result from a number of underlying causes (discussed below) that typically develop from inflammation into emphysema and chronic bronchitis. Some of these symptoms can also indicate lung cancer, so it is important to get checked out by a doctor right away if you are experiencing any of them.

Emphysema and chronic bronchitis are similar conditions that affect different parts of the lungs. Chronic bronchitis is an inflammation of the tissue in the bronchial tubes - large tubes leading from your main airway into each lung and down to the smaller tubes that lead to the individual small sacs (alveoli) that make up your lungs. Emphysema is a condition in which these small alveoli become destroyed (typically as a result of exposure to toxins, particulates, and irritating gases like cigarette smoke or carbon dioxide). 

These two conditions vary in severity in different COPD patients, though they are typically both present. COPD is a condition that develops as the bronchial tubes become more irritated and more alveolar sacs become damaged. This makes the other alveoli work harder, process more particles and toxins, and sustain damage. Eventually, this leads to the destruction of the lungs entirely. The word “chronic” in the name implies that COPD generally gets worse over time, and this disease is not yet reversible or curable. 

COPD patients often experience “COPD exacerbations” which are short-term increases in symptoms that can significantly decrease quality of life. The worsening symptoms seen in acute exacerbations are typically much worse than the baseline symptoms and the tolerability of these symptoms can be extremely low. Treatment options for severe chronic obstructive pulmonary disease include short-acting and long-acting bronchodilators and inhaled steroids and should be discussed with your doctor.

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2. What causes Chronic Obstructive Pulmonary Disease?

COPD has a number of different causes, mostly related to particles, toxins, and irritating gases in the environment. Not surprisingly, cigarette smoking is a major contributor to global COPD cases. Cigarette smoke is packed with toxins, irritating gases, and smoke particles that cause damage to alveolar sacs and the lining of bronchial tubes. In fact, in developed countries the main cause of COPD is tobacco smoking. In developing countries, many cases of COPD develop due to lifelong exposures to cooking and heating the home with an open flame and poor ventilation.

Though cigarette smoking is the most significant risk factor for COPD, this is simply because cigarettes are the most common form of smoking. Pipe smokers, cigar smokers, and cannabis smokers may also be contributing to the development of COPD. An overlooked factor is also secondhand smoke - especially with people who do not smoke themselves but live with a smoker or regularly experience secondhand smoke. Certain occupational hazards are also highly correlated with COPD, including industrial work that exposes workers to vapors, chemicals, and dusts

While only some lifelong smokers will develop apparent COPD, most smokers develop reduced lung function that can eventually degrade into other conditions. These conditions can sometimes be misdiagnosed as COPD until further examinations prove otherwise. Beyond these common causes of COPD, there is also a rare genetic disorder that can trigger the development of COPD.

Alpha-1-antitrypsin Deficiency

There is a particular protein in your lungs - alpha-1-antitrypsin (AAt) - that helps protect your lungs from damage. In about 1% of COPD cases, a genetic mutation causes a lack of this protein or a significant reduction in protein levels. Without this protein, it is much more likely that a person will develop emphysema or chronic bronchitis - regardless of whether or not they smoke or are exposed to other lung irritants.

COPD related to AAt deficiency is typically treated in the same way as other cases. However, if a genetic test and blood screening indicate a AAt deficiency, some patients are treated by replacing the missing AAt protein - a treatment which may be able to significantly reduce any further lung damage.  

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3. Preventing and Treating COPD

While the current interventional treatments for COPD are only partially effective, there are many preventative lifestyle choices you can make now to prevent COPD. In fact, one of the best things you can do to prevent COPD is to stop smoking and limit your exposure to toxic gases, dust (and other particulates), and avoid areas with other poor quality air. If you are employed in an industry that exposes you to high levels of irritating gases, particles, or other substances, be sure to use a proper respirator to avoid breathing in dangerous toxins and fumes. Talk to your supervisor or contact an OSHA representative to ensure you are being given the proper personal protective equipment. 

Since the majority of cases are directly related to cigarette smoking, never smoking or stopping now is your best bet to avoid developing COPD later in life. Longtime smokers have a harder time with this. Smoking cessation is never easy, given that nicotine is an addictive substance and smoking becomes a habit in your life. However, it is critical to your long-term health that you stop smoking now to avoid chronic lung damage in the future. Be sure to try every smoking cessation program you can find - different programs work better for different people and personalities. 

Another thing that can complicate and accelerate COPD is regular respiratory infections. During respiratory infections, bacterial cells reproduce in the bronchial tubes and alveoli in the lungs, causing damage as they do so. This can further the progress of COPD or start the process of chronic inflammation that eventually leads to the symptoms of COPD. You should consider getting the annual flu vaccine and the pneumococcal pneumonia vaccine to prevent dangerous respiratory infections and preserve your lung function.

Normal treatment of COPD usually includes bronchodilators (commonly used by asthma patients), which can help open up your bronchial tubes and reduce inflammation. Examples of these medications include albuterol, ipratropium, tiotropium, formoterol, or levalbuterol. Some doctors will prescribe inhaled corticosteroids (such as fluticasone or budesonide) instead. There are also combination inhalers, that include both a bronchodilator and an inhaled steroid for maximum effect (such as a combination of vilanterol and umeclidinium or olodaterol and tiotropium). Doctors may even prescribe a triple therapy in severe cases. Other treatments, such as the phosphodiesterase-4 agonist “roflumilast” are also available. 

Chronic obstructive pulmonary disease progresses quickly, and often results in symptoms that need additional treatments. These treatments include oxygen therapy and pulmonary rehabilitation programs that combine exercise and breathing therapy. Surgery is also an option for some patients with extreme emphysema - including lung volume reduction surgery or a full lung transplant. A doctor will conduct a number of tests (such as a spirometry test that will measure your lung function) in order to determine how severe your COPD is. 

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4. Latest Discoveries about COPD

COPD has been actively investigated for the past several decades because it is a very common cause of death in both developed and developing countries. While the above information is widely accepted general knowledge about COPD shared within the medical community, the last decade has been loaded with new information about COPD, its causes, and potential treatments.

For example, a recent literature review compiling data from the last decade describes COPD as a “disease of immunosenescence.” In other words, COPD may be caused by age-related declines in the immune system that cause low-grade, systemic inflammation in lung tissues. This leads to the bronchial inflammation and emphysema that often characterize COPD patients. 

The authors note that only 15-20% of smokers develop clinically significant COPD, suggesting that genetic pathways may be more responsible for COPD symptoms than previously thought. Since there are a huge number of genes that play into the operation of the immune system, this is not exactly surprising. It does give researchers a novel approach to studying the disease. 

Another meta-analysis of COPD patients and data revealed a negative association between Vitamin D levels in the bloodstream and COPD symptoms. In lay terms, that means that higher levels of Vitamin D in the bloodstream means that patients experience fewer symptoms and less exacerbation of their symptoms.

Recent evidence also indicates that COPD patients can benefit greatly from physical therapy and pulmonary rehabilitation. Essentially, a rehabilitation specialist can measure various aspects of a patient’s lung and muscular functions, both of which tend to decline with severe COPD. For instance, they may measure a patient’s expiratory volume, hypertension, and other biomarkers that can indicate the health status of a patient’s lungs. Then, a program of rehabilitative exercises can be developed that help the patient increase their lung capacity and rebuild muscles. Exercises that are good for COPD patients include endurance exercise like walking, resistance and strength training, respiratory muscle training, and even exercises like Yoga and Tai Chi - which combine strength, stretching, and breathing into a single exercise. 

Scientists have also made it clear that there is a clear benefit for COPD patients to receive their seasonal influenza vaccination, backed by 13 different randomized controlled trials and observational studies. The studies essentially showed that the flu vaccine posed “no evidence of an increased risk of [symptom] exacerbation” in COPD patients. Plus, protection from the flu virus is extremely beneficial in patients with decreased lung function of any kind. 

If you are interested in checking out all of the latest COPD findings, be sure to connect with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) to get regular reports on the best practices and treatments for COPD.

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5. Why are Clinical Trials important?

Clinical trials represent the final stages in drug and treatment development before a new medicine or therapy can be marketed to the general public. Clinical trials are a requirement of the Food and Drug Administration (FDA), before a company (such as AstraZeneca) can get approval to market their new medicine or treatment.

Essentially, there are three different phases of clinical trials that must take place. The first phase includes an extremely small number of trial participants who have volunteered to test the basic safety of the new drug or therapy. While this is the “riskiest” trial phase, most drugs have already gone through basic safety testing using chemical databases, modeling, and even tests in animals. So, there is a low chance that the drug or treatment will be harmful - though side effects in new medications are not uncommon.

Phase 2 includes many more volunteers, and researchers are more focused on determining whether or not the novel medication or treatment is more efficacious than other treatments or a lack of treatment. This phase will include an enormous amount of data collection and screening. The final phase, phase 3, includes hundreds or thousands of volunteers. By using this many study participants, researchers can ensure that the data they collected in phase 2 is representative of a larger group and they can screen a larger segment of the population for potentially rare side effects. 

Keep in mind that most randomized, double-blind control studies include a placebo (a non-active treatment that helps determine the actual effects of a particular medication or treatment). These placebo-controlled studies help ensure that the medical research is actually measuring the right outcomes. Patients will often receive a questionnaire at the end of a study to provide feedback on things like delivery method, airflow improvement, and the real world practicality of a treatment. 

Basically, clinical studies are important because they not only make sure that a medication or novel treatment will work, but they also ensure that it will be safe for the majority of people that use it. Only after these clinical trials can a medication or treatment be offered to the general public. As a volunteer, you will contribute to discoveries that will make life with COPD easier for current and future patients with the disease!

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Where to Find COPD Clinical Trials

Fortunately, there are many places conducting COPD clinical trials. All you have to do to get involved is to find a clinical trial that is right for you! For instance, check out these two clinical trials sponsored by Antidote:

• Age 40-85 | Diagnosed COPD | Current or Past Smoker | 3 or More Exacerbations
• Age 40+ | Diagnosed COPD | 1+ COPD Flare-ups | Currently taking COPD Medications
  
  

However, these are only 2 of many, many COPD trials being conducted. As a general rule, you should contact your primary care physician and any specialists you have seen for your COPD and ask them if they know of any clinical trials in your area. Doctors and specialists are often included in clinical trials - especially the larger phase 2 and phase 3 trials. 

If your doctor doesn’t know of any clinical trials in your area, there are many websites you can visit to locate clinical studies specific to COPD. Explore the websites below to find a COPD study in your area! (Some clinical trials are multicenter research studies, conducted concurrently at multiple places across the nation or globe. Many of these studies are funded by the National Institutes of Health (NIH).) 

• Antidote (Genomelink's trusted partner) - COPD Clinical Trials
• ClinicalTrials.gov - COPD Clinical Trials
• CenterWatch - Chronic Obstructive Pulmonary Disease Clinical Trials
• Mayo Clinic - Find COPD Clinical Trials
• American Lung Association - Clinical Trials for COPD
  

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Be sure to search each of these websites thoroughly to find a clinical trial that:

1. Is in your area.
2. You are eligible for (age, disease, specific symptoms, etc.)
3. You are comfortable taking part in.
4. You are not excluded from based on a comorbidity or other factor.

If you are not sure whether or not you are eligible for a particular study, be sure to reach out to the study coordinator (typically listed with each study). These professionals can ask the right questions to determine whether or not a specific study will be right for you. Good luck!

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Citations

Mayo Clinic - COPD Symptoms and Causes

Mayo Clinic - COPD Diagnosis and Treatment

National Institutes of Health (NIH | NHLBI) - Chronic Obstructive Pulmonary Disease

Yonsei Medical Journal - COPD as a Disease of Immunosenescence

Respiratory Medicine - The relationship between Vitamin D status and exacerbation in COPD patients - a literature review

International Journal of Chronic Obstructive Pulmonary Disease - Exercise assessments and trainings of pulmonary rehabilitation in COPD: a literature review