An Observational Study to Evaluate Lung Health in Young Adults

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

A Study for those with COPD and Chronic Bronchitis

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

A Treatment Study For COPD

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

The impact of E-Cigarette use on the lungs

Official Title
The Effects of a Standardized Research E-Cigarette on the Human Lung
Purpose

This study will look at the effects of electronic cigarette (e-cig) use on the lung (particularly lung inflammation). The study will be of 160 smokers. Some participants will be given a standardized research e-cig (SREC) or nicotine replacement therapy (NRT). The information from this study will help researchers learn if there is any short-term harm to the lung when using e-cigs.

*Samples for the study will taken by two bronchoscopy procedures.

Could this study be right for you?

You may be eligible if you:
- Are 21- 40 years old
- Are a smoker

Age Range
21 and up

A Study on the Development of COPD

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

Biomarkers of Sickle Cell Lung Disease -BOLD

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