Novel Therapies for Muco-Obstructive Lung Diseases: Testing the Transnasal Pulmonary Delivery Device in COPD/CB Subjects

Withdrawn before enrolling · Not applicable

Conditions studied: COPD, Chronic Bronchitis

In brief

The primary objective of this study is to assess tolerability and effect of HS (hypertonic saline) delivered with the tPAD (transnasal Pulmonary Aerosol Delivery) device on mucociliary clearance (MCC) in chronic obstructive pulmonary disease/chronic bronchitis (COPD/CB) subjects. The investigators hypothesize that HS delivery via tPAD will be safe and and while, and will improve MCC.

Key facts

Study ID

NCT02341183

Run by

University of North Carolina, Chapel Hill

People needed

0

Starts

2016-05-01

Expected to finish

2016-05-01

Last updated by the study team

2017-06-23

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who meet the following criteria will be eligible for study participation:
• Subjects aged 40 to 80 years (inclusive), and with a body mass index (BMI) < 35 kg/m2
• Female subjects must be non-pregnant and must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or, must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation
• Subjects who are in their baseline state of health, as determined by a medical history and examination
• Subjects who have normal lung function with a FEV1 of 30% - 80% predicted and a FEV1/FVC <70%
• Subjects who are capable of providing written informed consent in English to participate in the study
• Produces sputum two days per week or more, on average.
• History of smoking cigarettes ≥ 10 pack years.

You may not qualify if…

• Subjects will be excluded from the study according to the following criteria:
• Subjects who use oxygen continuously or require it at night.
• Subjects with an FEV1 < 30% or > 80% or an FEV1/FVC of ≥70% at screening.
• Subjects who chronically require > 10mg per day of prednisone (or equivalent corticosteroid dose).
• Subjects with a concomitant presence of congestive heart failure, active coronary syndromes, or other disease that in the opinion of the investigator would increase the risk resulting from participation.
• Subjects with a recent change in respiratory medications, including new antibiotic or systemic corticosteroid interventions within the last 4 weeks.
• Subjects with a history of intolerance or hypersensitivity to hypertonic saline or short acting inhaled beta agonists.
• Subjects with significant bronchoreactivity by examination or PFT testing that, in the opinion of the investigator, would increase the risk of HS use.
• Subjects who have had radiation exposure within the 12 months prior to study participation that would cause them to exceed Federal Regulations by participating in this study.
• Subjects with symptomatically active, chronic or acute rhinosinusitis, or other nasal abnormality that could interfere with aerosol delivery or impact subject safety.
• Subjects with a positive pregnancy test or who are nursing.
• Subjects who have been diagnosed with obstructive sleep apnea.
• Subjects who, in the opinion of the Principal Investigator, should not participate in the study.

Where it is running

• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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