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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: |
NCT00928135 |
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Date of registration:
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18/06/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) Subjects
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Scientific title:
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Randomized Controlled Study of Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Hospitalized Patients With Exacerbation of Cystic Fibrosis |
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Date of first enrolment:
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January 22, 2013 |
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Target sample size:
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63 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00928135 |
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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: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 1/Phase 2
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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 Zabner, M.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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PMID: 16781897 |
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Name:
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Jan L Launspach, R.N., CCRC |
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Address:
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Telephone:
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Email:
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Affiliation:
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PMID: 16781897 |
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Name:
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Lakshmi Durairaj, M.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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PMID: 16781897 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects with CF (medical record evidence of CFTR(Cystic fibrosis transmembrane
conductance regulator) mutation or sweat chloride test or nasal voltage difference,
and 1 or more clinical findings of CF),
- Age 12 or greater
- FEV1 > 30% predicted(within the last 14 days and oxygen saturation > 90% on
FiO2(fraction of inspired oxygen) = 50%,
- Admitted for an exacerbation,
- Use of effective contraception in women,
- Able to provide written informed consent.
Exclusion Criteria:
- Pregnancy,
- History of asthma based on methacholine challenge or bronchial hyperresponsiveness on
PFTS(Pulmonary Function Test),
- Hemoptysis more than 60 mL within the last 30 days,
- Use of any investigational study drug within the last 30 days,
- Initiation of hypertonic saline within the last 30 days,
- A serum creatinine 2 mg/dl or more
- Active malignancy in the last year
- Antibiotics for CF exacerbation as an outpatient in the last 2 weeks
- B cepacia colonization
- Waiting list for lung transplant
- Lack of FEV1 data from the last 14 days
- Previous participation in this study
Age minimum:
12 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: Saline
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Drug: Xylitol
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Primary Outcome(s)
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The primary outcomes will be safety as assessed by FEV1 change from baseline, adverse events and respiratory symptom score.
[Time Frame: 14 days]
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Secondary Outcome(s)
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Outcomes for trend in efficacy include density of colonization per gram of sputum, time to next exacerbation, sputum cytokines and revised CF quality of life questionnaire.
[Time Frame: 14 days]
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Secondary ID(s)
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200901713
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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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