Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02141191 |
Date of registration:
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12/05/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of Lung Clearance After Hypertonic Saline Delivery Using the tPAD Device
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Scientific title:
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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:
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June 2014 |
Target sample size:
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12 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02141191 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Joseph M Pilewski, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: inhaled hypertonic saline (7%)
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Primary Outcome(s)
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mucociliary clearance
[Time Frame: 6 hours]
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Secondary Outcome(s)
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DTPA absorption
[Time Frame: 6 hours]
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pulmonary function measurements
[Time Frame: 12 hours]
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safety and tolerability measurements
[Time Frame: 12 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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