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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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19 February 2015 |
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Main ID: |
NCT00721071 |
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Date of registration:
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21/07/2008 |
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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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Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis
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Scientific title:
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Diagnostic Utility of Induced Sputum Using Hypertonic Saline to Evaluate Airway Infection and Inflammation in Cystic Fibrosis |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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95 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00721071 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Felix Ratjen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children, Toronto Canada |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Children diagnosed with CF (by sweat chloride =60 and/or genetic testing)
2. Children ages between 6-18 years
3. Ability to perform pulmonary function tests
4. FEV1 = 30% predicted18.
Additional inclusion criteria for sub-sample undergoing antibiotic therapy:
1. Above criteria
2. Admitted to hospital for i.v. antibiotic therapy
Exclusion Criteria:
1. Acute respiratory distress or hypoxia (oxygen saturation <92% at room air)
2. New onset of wheezing
3. Previous history of intolerance of inhalation of HS
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
Both
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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: Hypertonic Saline
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Primary Outcome(s)
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Additional positive bacterial culture yield post IS technique for known and emerging CF pathogens over conventional methods of bacterial culturing (ES and TS).
[Time Frame: 60 minutes; for subgroup, this will be repeated a second time after 14 days.]
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Secondary Outcome(s)
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Inflammatory profile as measured by relative neutrophil count and IL-8 concentration in the IS
[Time Frame: 60 minutes; for subgroup, this will be repeated a second time after 14 days.]
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Bacterial colony counts
[Time Frame: 60 minutes; for subgroup, this will be repeated a second time after 14 days.]
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Frequency of change in clinical management based on results from IS
[Time Frame: 60 minutes; for subgroup, this will be repeated a second time after 14 days.]
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Secondary ID(s)
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1000009154
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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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