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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12 December 2020 |
Main ID: |
NCT01355796 |
Date of registration:
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16/05/2011 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Inhaled Xylitol Versus Saline in Stable Subjects With Cystic Fibrosis
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Scientific title:
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Randomized Cross Over Study of Inhaled Hypertonic Xylitol Versus Hypertonic Saline in Stable Subjects With Cystic Fibrosis |
Date of first enrolment:
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May 2011 |
Target sample size:
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30 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01355796 |
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/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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Lakshmi Durairaj, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Iowa |
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Name:
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Joseph Zabner, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Iowa |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Documented diagnosis of CF (medical record evidence of 2 identified CFTR(Cystic
fibrosis transmembrane conductance regulator) mutations or a positive sweat chloride
test or nasal voltage difference, and 1 or more clinical findings of CF)
- Age 16 or greater
- FEV1>30% predicted
- Oxygen saturation > or equal too 90% on room air
- Clinically stable, without evidence of pulmona4ry exacerbation for at least 2 weeks
prior to screening (defined as use of oral or intravenous antibiotics for cystic
fibrosis exacerbation)
- Use of effective contraception in women
- Ability to provide written informed consent and assent
- Successful completion of the trial doses of study drugs
Exclusion Criteria:
- Pregnancy
- Hemoptysis more than 100 mL within the last 30 days
- Change in chronic medication within the last 30 days
- History of elevated serum creatinine (> than or equal to 2 mg/dl) within 30 days or at
screening
- History of lung and other solid organ transplantation
- Wait-listed for lung or other solid organ transplant
- Known intolerance to inhaled hypertonic saline
Age minimum:
16 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: Hypertonic saline
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Drug: Xylitol
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Primary Outcome(s)
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Change in FEV1 % Predicted From Baseline
[Time Frame: Baseline and 14 days]
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Secondary Outcome(s)
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Sputum Density
[Time Frame: baseline and 14 days]
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Secondary ID(s)
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201209728
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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