Lungs and Breathing

Official Title

Assessing the Impact of an FDA Ban on Menthol Cigarettes on Tobacco-Related Health Disparities in African American Smokers

Purpose

The main reason this study is being done is to assess the impact of the FDA’s (and Columbus) menthol ban on African American (AA) communities. This information will provide the Food and Drug Administration (FDA) with needed information on the impact of a menthol ban on the population most affected by such a policy. The study will focus on collecting survey data on AA menthol smokers’ perception of a menthol ban, their awareness/accessibility to quitting support, and their willingness to enroll in a future study.

Could this study be right for you?

All participants must be self-identified AAs and then sorted into the following categories:

• A Current Menthol smoker is defined as someone who regularly smokes menthol cigarette smokers, at least 5 cigs/day for > 1 year.
• A Former menthol smoker is defined as someone who quit menthol cigarette smoking for >6 months, who previously smoked >5 cigs/day for >1 year.
• Never-smoker is defined as someone who smoked < 100 cigs in their lifetime (CDC definition) and none for >1 year.

Additional eligibility criteria include:

(1) between 21 and 50 years old; (2) access to a smartphone or email, and (3) reading and speaking English.

Age Range

21 - 50 years

Official Title

Reducing exercise intolerance through inspiratory muscle training in obese breast cancer survivors (IMOCS)

Purpose

The purpose of this study is to better understand why some survivors of breast cancer have difficulty exercising. We also want to learn if breathing exercises can make it easier to tolerate exercise. 

Could this study be right for you?

• Breast Cancer Survivor
• Completed treatment within 6 months–5 years
• Have obesity, defined as body mass index between 30-50 kg/m2
• Can exercise independently

Age Range

18 years and up

Official Title

The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function
in a High-Risk Cohort for Lung Cancer

Purpose

The purpose of the study is to examine the effects of exercise on long-term smokers in reducing lung cancer risk.

Could this study be right for you?

• Males and females aged 55 to 77 years old
• Current or former smokers with a 20-pack year smoking history (equals 1 pack a day for 20 years, 2 packs a day for 15 years, etc) and smoked within the last 15 years
• Sedentary Lifestyle: fewer than 60 minutes of participation in moderate intensity physical activity each
• Health Status: participants must be free of severe heart, respiratory (e.g. COPD), or systemic disease that would make moderate intensity exercise participation unsafe
• Not currently undergoing cancer treatment
• Not currently taking  Immunosuppressants, bisphosphonates, steroids, or probiotics
• No plan to change smoking status

 

Age Range

55 - 77 years

Official Title

A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)

Purpose

The purpose of this study is to see if benralizumab (biologic drug), given as injections under the skin, can help control your Hypereosinophilic Syndrome (HES) better if it is added to available standard of care HES medications which you may be currently taking. 

HES (Hypereosinophilic Syndrome) is a disease characterized by high levels of eosinophils (a particular type of white blood cell) in your blood and a build-up of eosinophils in some organs and tissues (like skin, heart, lungs, intestines or others) causing their dysfunction.

The duration of the study will last 18 months.

Could this study be right for you?

 

• Eosinophil (a type of white blood cells) count ≥ 1000 cells/μL at screening
• Documented diagnosis of Hypereosinophilic Syndrome (HES)
• History of persistent eosinophilia >1500 cells/μL (at least 2 examinations, interval ≥1 month)
• End organ manifestations attributable to the eosinophilia

Inclusion and Exclusion Criteria varies, please contact Study Coordinator for more information.

Age Range

18 years and up

Official Title

[American Lung Association (ALA)] Lung Health Cohort (LHC) Study

Purpose

The purpose of this study is to examine why some people have better lung function than others as young adults during the period of peak lung health (ages 25 to 35 years old). The long-term goal of this study is to come up with ideas about how to promote the best possible lung function in young adults.

Participation in this study will be 4.5 years.

Could this study be right for you?

Inclusion Criteria:
• Men and women aged 25-35 years old at time of examination
• Able to read and understand English or Spanish
• Have a social security number

Exclusion Criteria:
• Severe asthma or other chronic lung disease
• Diagnosed cardiovascular disease
• History of cancer other than non-melanoma skin cancer
• Currently pregnant

Age Range

25 and up

Official Title

A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD

Purpose

RheOx (Gala Therapeutics, Inc.) is an investigational device designed to reduce cough and mucus production through a minimally-invasive procedure. The procedure is performed through a bronchoscope, a thin flexible tube that is inserted through the mouth into the lungs. Once in place, RheOx delivers short bursts of electrical energy to the inner walls of the bronchi, eliminating the mucus-producing cells. Over the next several days, new cells grow and produce less mucus. The right lung is treated first, followed by treatment of the left lung about 1 month later.

RheOx has been studied in three clinical trials and has shown a significant improvement in quality of life and a reduction in cough and mucus at 12 months.

Could this study be right for you?

You may be eligible if:
-You are at least 35 years of age.
-Have chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out
-You are receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to randomization
-You have a cigarette smoking history of at least ten pack years.
-Other criteria that will be reviewed by the study team

You will not be eligible if you have:
- A known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
- A steroid-dependent condition requiring more than 10 mg of oral corticosteroid per day.
- Any implantable electronic device (e.g., pacemaker, cardioverter defibrillator, neuro-stimulation devices).
- A history of arrhythmia within past two years which includes tachy-atrial arrhythmias, any ventricular tachy-arrhythmias, or sinus bradycardia with heart rate less than 45 beats per minute.
- Unresolved lung cancer.
- A pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
- Had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy. Prior pneumothorax without lung resection, pleural procedures without surgery, or segmentectomy are acceptable.
- Asthma based on Global Initiative for Asthma (GINA) criteria.
- Smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
- Unable to walk over 238 feet in 6 minutes.
- Uncontrolled GERD.
- Had prior severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation.
- A known allergy to nickel.
- Other criteria will be reviewed by the study team

Age Range

35 and up

Official Title

A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease with Chronic Bronchitis (SPRAY-CB)

Purpose

The purpose of this study is to determine the safety and effectiveness of a device called the RejuvenAir® System, developed for patients with chronic bronchitis. The primary objective of this trial is to demonstrate the safety and effectiveness of the RejuvenAir® System for the treatment of adult subjects with a diagnosis of CB defined as COPD with classic 3 months of cough and sputum production for a minimum of 2 years who demonstrate ongoing symptoms of cough and significant mucus production. You will be in the study for approximately 36 months, including the screening period.

Could this study be right for you?

Inclusion Criteria: 1. Males and females 40-80 years of age 2. Must demonstrate daily cough and significant mucus production 3. Have had a diagnosis of chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) for a minimum of two years. (CB is defined clinically as chronic productive cough for 3 months in each of 2 successive years in a patient in whom other causes of productive cough have been excluded) 4. Smoking history of at least 10 pack years 5. Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study Exclusion Criteria: 1. Have had an acute pulmonary infection, exacerbation or pneumonia requiring medical treatment (with antibiotics and/or steroids) within 4 weeks prior of initially planned study bronchoscopy 2. Diagnosis of Asthma 3. You have had any type of transplant procedure 4. Use e-cigarettes, vaping or inhaled substances not prescribed by a physician RejuvenAir® System 5. You are pregnant, nursing, or planning to get pregnant during study * This is a not a complete list of either inclusion or exclusion criteria

Age Range

40 and up

Official Title

A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira™ Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Purpose

The purpose of this research study is to evaluate the safety and efficacy of the Nuvaira System, which is made by Nuvaira, Inc., for Targeted Lung Denervation (TLD) Therapy.

The primary purpose of conducting this study is to see if TLD Therapy in addition to optimal medical care (daily breathing medications you have been prescribed by your doctor) is better at reducing a moderate or severe worsening of symptoms (known as an COPD flare-ups or exacerbations) and related hospitalizations than optimal medical care (daily breathing medications you have been prescribed by your doctor) alone.

Could this study be right for you?

Inclusion Criteria:
• Between 40 and 75 years of age
• Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the study
• Diagnosis of COPD with 30% ≤ FEV1 <60% of predicted and FEV1/FVC <70% (post-bronchodilator)
• SpO2 of at least 89% on room air at the time of screening
• Has a documented history of having minimally been taking a regular respiratory maintenance medication for at least 12 months at the time of consent; medications will be reviewed by study team
• If you have participated in a formal pulmonary rehabilitation program recently, program completion should have occurred more than 3 months prior to consent; if in a maintenance program, you will agree to continue your current program through your 12-month follow-up visit;
• Additional criteria will be reviewed by the study team

Involvement in this study will last approximately 62 months.

Age Range

40 and up

Official Title

Extracellular vesicles and the development of COPD

Purpose

The study is being done to learn more about how certain smokers develop COPD, chronic obstructive pulmonary disease. By studying microscopic particles (extracellular vesicles) in the blood and lung fluid from smokers we can learn more about this process. This information could lead to better understanding of how smoking damages the lungs and could ultimately help design treatments for people with or at risk for COPD

Could this study be right for you?

- 21 years of age and older
- Current Smoker with at least 10 pack year history
- With or without diagnosis of COPD
- Willing to participate in bronchoscopy procedure
- Not currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis), lung cancer, primary pulmonary hypertension or have active cardiac disease

Age Range

21 and up

Official Title

Biomarkers of Sickle Cell Lung Disease -BOLD

Purpose

This is a study to determine risk factors for developing lung disease in children with sickle cell disease (SCD). Specifically we are researching factors that lead to the development of Acute Chest Syndrome, a pneumonia-like illness that affects many children with SCD.

Could this study be right for you?

--Diagnosis of Sickle Cell Disease (SCD)
--under the age of 19