A Study of Lung Clearance After Hypertonic Saline Delivery Using the tPAD Device

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine whether a single overnight, eight-hour administration of a 7% NaCl solution delivered by the Parion Sciences transnasal Pulmonary Aerosol Delivery (tPAD) device has a significant effect on mucociliary clearance in subjects with cystic fibrosis, as compared to no treatment. This study will be conducted at the University of Pittsburgh Medical Center.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: Parion Sciences

Criteria

Inclusion Criteria:

• Has a diagnosis of CF via standard criteria

• Is aged 18 years or older

• Is capable of providing written informed consent in English to participate in the study.

• Has a forced expiratory volume in 1 second (FEV1) >= 40% and < 110% predicted normal for age, gender, and height at Screening.

• Has a body mass index (BMI) < 30 kg/m2

• Can tolerate cessation of treatment with HS for 72 hours and rhDNase for 24 hours prior to each treatment visit until discharge from Visits 2 and 3.

• Can tolerate cessation of treatment with long-acting beta-agonists (LABAs) for 12 hours and short-acting beta-agonists (SABAs) for 6 hours prior to radioaerosol administration for each MCC measurement and at least until discharge from Visits 2 and 3

• Is on a stable medication regimen for at least 28 days before start of dosing and can continue such regimen for duration of study

• Tolerates the 30 minute administration of 7% HS by the tPAD device at screening without subjective intolerance, oxyhemoglobin desaturation, or significant change in spirometry (>10% reduction from pre-dose value in FEV1, measured 30 minutes after completion of the aerosol administration)

Exclusion Criteria:

• Has evidence of an acute upper or lower respiratory infection or clinically significant illness at screening or within 28 days prior to the start of dosing

• Required an acute intervention with antibiotics (oral, inhaled, or IV) or systemic corticosteroids within the last 28 days for a respiratory illness

• Has a history of intolerance to a beta-agonist or hypertonic saline

• Has evidence of significant nasal obstruction that impairs the ability to breathe through the nose

• Has a clinical diagnosis of sleep apnea

• Has current symptoms of allergic rhinitis

• Is unable to maintain a stable dosage regimen of any concomitant medication throughout the duration of the trial.

• Has participated in a clinical drug or investigational device trial within the past 28 days

• Has a history of positive test for Burkholderia cepacia

• Has a present history of any clinically significant and uncontrolled neurologic, gastrointestinal, renal, hepatic, cardiovascular (including hyper/hypotension and tachy/bradycardia), psychological, pulmonary, metabolic, endocrine, or hematological disorder or disease, or any other major disorder or disease, in the opinion of the investigator

• Has a history of smoking within the last 12 months

• Is known to be pregnant, has a positive urine pregnancy test or is nursing (female subjects only)

• Should not participate in the study, in the opinion of the Principal or Clinical investigator