Trial · NCT00782288
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | 42 days (Day 1 to Day 42) | Sputum was collected for Il-8 biomarkers on Days 1,14, 21, 28 during the treatment phase and at Day 42. Measures were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between placebo and the two doses. | log 10 (pg/mL) | MEDIAN |
| SECONDARY | Pharmacokinetics (PK) of Digitoxin in Serum in Stable CF Patients. | Serum PK on Days 1 (pre-dose), 7, 14, 21 and 42 | Subjects had serum digitoxin levels drawn at Day 1 (pre-dose) with no levels observed, as expected. Digitoxin was drawn on Day 7, 14, 21 and 42 to determine the number of subjects with a detectable level of digitoxin (ng/mL) in serum by group. | participants | NUMBER |
| SECONDARY | Safety Indices Including Change in FEV1 in Stable CF Patients. | Baseline and Day 28 | Median changes in FEV1 in L by group for the 28 days of treatment. | liters | MEDIAN |
| SECONDARY | Mean Change in Quality of Life Scores, for Each Domain, From Day 1 to Day 42 Using the Cystic Fibrosis Questionnaire Revised (CFQ-R). | Baseline and Day 42 | Mean change in CFQ-R scores from Visit 1 to Visit 6, by domain. | mean change of scores on a scale | MEAN |
| SECONDARY | Change in WBC (White Blood Cell) Count by Group During Treatment Period | Baseline and Day 28 | Safety indices included changes in WBC during treatment for each group. | K/cu mm | MEDIAN |
| PRIMARY | Change in Il-8 (Interleukin 8) Levels From Day 28 Minus Day 1 (Treatment Period). | 28 days (Day 28 minus Day 1) | For change in Il-8 from Day 28 minus Day 1, a Kruskal-Wallis equality of populations rank was performed. | log10 (pg/mL) | MEDIAN |
| PRIMARY | Effect of Digitoxin on Neutrophil Counts in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | 42 days (Day 1- Day 42) | Neutrophil cell counts were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between the placebo and the two digitoxin dose levels. | log 10 (neutrophil cells/mL) | MEDIAN |
| PRIMARY | Change in Neutrophil Cell Count Day 28 Minus Day 1 (Treatment Period). | 28 days (Day 28 minus Day 1) | The change in neutrophil cell count from Day 1 to Day 28 was performed using a Kruskal-Wallis equality of populations rank test. The cells counts are expressed as log 10 (neutrophil cell/mL). | log 10 (neutrophil cell/mL) | MEDIAN |
| SECONDARY | Changes in C Reactive Protein (CRP) During Treatment. | Baseline and Day 28 | All subjects had blood labs for CRP drawn on Visits 1,3,4 and 5. The changes in median CRP were calculated during the Treatment Period (28 days). | mg/dL | MEDIAN |
| SECONDARY | Changes in Erythrocyte Sedimentation Rate (ESR) During Treatment Period. | Baseline and Day 28 | All subjects had blood labs for ESR drawn on Visits 1,3,4 and 5. The changes in median ESR were calculated during the Treatment Period (28 days). | mm/hr | MEDIAN |
| SECONDARY | Number of CF Subjects With Microarray Results From Nasal Epithelial Cells to Measure the Effect of Digitoxin on Gene Expression. | Day 0 and Day 28 | The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). Results can be found under the accession number GSE76347. One subject's pair of specimens in the placebo group was not collected. | participants | NUMBER |
| SECONDARY | Clinically Significant Alterations in ECG Readings | 28 days | Count of clinically significant alterations in the ECG in all subjects during the Treatment Phase of the study. | participants | NUMBER |
| SECONDARY | Clinically Significant Changes in the Microbiology of Sputum in Subjects | 28 days | There were no significant changes in the microbiology of sputum in any subjects over the course of treatment. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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