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within category "Lung & Respiratory"
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RejuvenAir® System Trial for COPD With Chronic Bronchitis (SPRAY-CB)
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air
within the lungs and is a major public health problem that is projected to rank fifth
worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB)
is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically
defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2,
but many studies have used different definitions to define it- chronic cough and sputum
production for one year or cough and sputum production on most days of the week. CB is
associated with multiple clinical consequences, including; the worsening of lung function
decline, increasing risk of acute exacerbations of COPD, increased risk of developing
pneumonia, reduced health related quality of life, and an increase in all-cause mortality.
J Ferguson, MD
All
40 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03893370
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Inclusion Criteria
• Males and females ≥40 to ≤80 years of age
• Subject is able to read, understand, and sign a written Informed Consent in order to
participate in the Study
• Subject has a diagnosis of chronic bronchitis (CB) and/or chronic obstructive
pulmonary disease (COPD) for a minimum of two years. (Chronic Bronchitis 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)
• Subject is classified as having a moderate or severe (GOLD 2/3) airflow obstruction
defined by a post-bronchodilator of ≥30% FEV1 to <80% predicted with a baseline
FEV1/FVC of <0.70
• Subject has a Baseline SGRQ of ≥50
• Subject demonstrates daily cough and significant mucus.
• Subject is being treated according to current medically accepted treatment guidelines
for chronic bronchitis for minimum of 3 months prior to enrollment into the study.
Subject agrees to continue maintenance pulmonary/COPD medications (GOLD standard
medications recommended) for the duration of the study
• Non-smoking for a minimum of 2 months prior to consent and agrees to continue not
smoking for the duration of the study
• Subject is able to adhere to and undergo 2 bronchoscopic procedures (cross over
subjects may undergo two additional bronchoscopic procedures, if they agree to
treatment), per hospital guidelines
• Subject demonstrates ability and willingness to use a daily eDiary
Exclusion Criteria
• Subject has 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
• Current diagnosis of Asthma
• Subject has Alpha-1 antitrypsin deficiency as defined by blood level <59 mg/dL
• Subject has other origins of respiratory disease aside from chronic bronchitis and
COPD
• Subject is using e-cigarettes, vaping or taking any inhaled substances not prescribed
by a physician
• Subject has untreatable or life threatening arrhythmias, inability to adequately
oxygenate during the bronchoscopy, or has acute respiratory failure
• Subject has bullous emphysema characterized as large bullae >30 millimeters on HRCT;
or subject has stenosis in the tracheobronchial system, tracheobronchomegaly,
trachea-bronchomalacia, amyloidosis or cystic fibrosis
• Subject has clinically significant bronchiectasis
• Subject has had a solid transplant procedure
• Subject has a known mucosal tear, has undergone prior lung surgery such as
pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery
• Subject has had a prior lung device procedure, including emphysema stent(s) implanted,
lung coils, valves, lung denervation, bronchial thermoplasty, cryotherapy or other
therapies
• Subject is unable to temporarily discontinue use of anticoagulant therapy: warfarin,
Coumadin, LMWH, heparin, clopidrogel (or equal)
• Subject has a serious medical condition, such as: uncontrolled coagulopathy or
bleeding disorder, congestive heart failure, uncontrolled angina, myocardial
infarction in the past year, renal failure, liver disease, cerebrovascular accident
within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or
uncontrolled gastric reflux
• Subject is pregnant, nursing, or planning to get pregnant during study duration
• Subject has or is receiving chemotherapy or active radiation therapy within the past 6
months or is expected to receive chemotherapy during participation in this study
• Subject is or has been in another treatment study within 6 weeks of enrollment and
agrees to not participate in any other treatment studies for the duration of study
participation
• Subject has known sensitivity to medication required to perform bronchoscopy (such as
lidocaine, atropine, and benzodiazepines)
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