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

Completed · Phase 1 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT02141191

Run by

University of Pittsburgh

People needed

12

Starts

2014-06-01

Expected to finish

2015-10-01

Last updated by the study team

2017-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.