Clinical TrialID 2318
Phase II Study of Digitoxin to Treat Cystic Fibrosis
NCT00782288
Cystic Fibrosis
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 2318
- Evidence Id
- 2318
- Core Evidence Id
- 2318
- Source Clinical Trial Id
- 2292
- Herb2 Clinical Trial Id
- HBCT002292
- Nct Id
- NCT00782288
- Title
- Phase II Study of Digitoxin to Treat Cystic Fibrosis
- Status
- Completed
- Phase
- Phase 2
- Study Result
- Yes
- Study Condition
- Cystic Fibrosis
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: digitoxin|DRUG: digitoxin|OTHER: placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Triple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult
- Enrollment
- 24
- Outcome Measure
- Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients., The Il-8 measurements of sputum digitoxin levels for each group is shown for 5 days (Days 1, 14, 21, 28 and 42)., 42 days (Day 1 to Day 42)|Change in Il-8 (Interleukin 8) Levels From Day 28 Minus Day 1 (Treatment Period)., Change in Il-8 values are expressed as a change in log 10 Il-8 pg/mL from Day 28 minus Day 1., 28 days (Day 28 minus Day 1)|Effect of Digitoxin on Neutrophil Counts in Induced Sputum in Stable Cystic Fibrosis (CF) Patients., The neutrophil counts were measured in the induced sputum of participants in each group on study 5 days (Days 1, 14, 21, 28 and 42)., 42 days (Day 1- Day 42)|Change in Neutrophil Cell Count Day 28 Minus Day 1 (Treatment Period)., The change in log 10 neutrophil cell count from Day 28 minus Day 1 (during the treatment period) expressed as log (10\^4 neutrophil/mL)., 28 days (Day 28 minus Day 1)
- Sponsor Collaborator
- National Jewish Health
- Funded By
- OTHER
- Location
- Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States
- Other Id
- FD-R-003456-01
- Start Date
- 2010-08
- Primary Completion Date
- 2016-08
- Completion Date
- 2016-08
- First Posted
- 2008-10-31
- Results First Posted
- 2016-01-22
- Last Update Posted
- 2022-04-21
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT00782288
- Title Cn
- Title En
- Phase II Study of Digitoxin to Treat Cystic Fibrosis
- Bilingual Status
- semi_complete