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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02141191
• Date of registration: 12/05/2014
• Prospective Registration: Yes
• Primary sponsor: University of Pittsburgh
• Public title: A Study of Lung Clearance After Hypertonic Saline Delivery Using the tPAD Device
• Scientific title: A Randomized Crossover Mucociliary Clearance Study of Aerosolized 7% NaCl Solution Administered Overnight by the tPAD Device to Subjects With Cystic Fibrosis
• Date of first enrolment: June 2014
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02141191
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Joseph M Pilewski, MD
• Affiliation: University of Pittsburgh

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: inhaled hypertonic saline (7%)

Primary Outcome(s)

mucociliary clearance [Time Frame: 6 hours]

Secondary Outcome(s)

DTPA absorption [Time Frame: 6 hours]

pulmonary function measurements [Time Frame: 12 hours]

safety and tolerability measurements [Time Frame: 12 hours]

Secondary ID(s)

PS-D201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Parion Sciences