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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: |
NCT01223183 |
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Date of registration:
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14/10/2010 |
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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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Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis
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Scientific title:
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Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01223183 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover 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, PhD |
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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:
- age = 18 years
- diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical
symptoms
- clinically stable as determined by the investigator (pulmonologist)
Exclusion Criteria:
- intolerant to hypertonic saline.
- FEV1%p <40% of predicted
- nursing mother
- positive urine pregnancy test
- unwilling to stop hypertonic saline therapy for 72 hours prior to each test day
- cigarette smoker (regular smoking within 6 months of study)
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: isotonic saline
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Drug: hypertonic saline (7%)
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Primary Outcome(s)
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Mucociliary Clearance Rate After Isotonic Saline Inhalation
[Time Frame: 80 minutes after radiopharmaceutical inhalation]
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Absorptive Clearance Rate After Isotonic Saline Inhalation
[Time Frame: 80 minutes after radiopharmaceutical inhalation]
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Absorptive Clearance Rate After Hypertonic Saline Inhalation
[Time Frame: 80 minutes after radiopharmaceutical inhalation]
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Mucociliary Clearance Rate After Hypertonic Saline Inhalation
[Time Frame: 80 minutes after radiopharmaceutical inhalation]
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Secondary ID(s)
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PRO09080375
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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