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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01887197 |
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Date of registration:
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24/06/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Repeatability and Response Study of Absorptive Clearance Scans
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Scientific title:
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Repeatability and Response Study of Absorptive Clearance Scans |
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Date of first enrolment:
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June 2013 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01887197 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. 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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Tim Corcoran, Ph.D. |
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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:
- subjects 18 years old or older with a diagnosis of cystic fibrosis as determined by
sweat test or genotype and clinical symptoms who are clinically stable as determined
by a physician co-investigator
Exclusion Criteria:
- one second forced expiratory volume (FEV1) <50% of predicted
- nursing mother
- positive urine pregnancy test or unwilling to test
- cigarette smoker
- unwilling to stop hypertonic saline therapy for 72 hours prior to each test day
- are intolerant to hypertonic saline (response only)
- are intolerant to any inhaled therapies (response only)
- fail mannitol tolerance testing (response only)
- have a history of excessive (uncontrollable) coughing after an osmotic stimulus
(response only)
- have a history of hemoptysis (response only)
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: mannitol inhalation powder
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Drug: inhaled hypertonic saline (7%)
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Other: Absorptive clearance scan
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Primary Outcome(s)
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absorptive clearance response
[Time Frame: 14 day]
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absorptive clearance variability
[Time Frame: 30 days]
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Secondary ID(s)
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1RO1 HL108929-01 (B)
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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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