Trial · NCT00782288
Phase II Study of Digitoxin to Treat Cystic Fibrosis
NCT00782288, Phase 2, Completed, National Jewish Health; results first posted 2016-01-22
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ConductScience Library. Phase II Study of Digitoxin to Treat Cystic Fibrosis. Trials, record NCT00782288. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00782288
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Digitoxin to Treat Cystic Fibrosis
- NCT number
- NCT00782288
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- National Jewish Health
- Conditions
- Cystic Fibrosis
- Interventions
- digitoxin, digitoxin, placebo
- First posted
- 2008-10-31
- Last updated
- 2022-04-21
- Results first posted
- 2016-01-22
- Limitations and caveats
Steady states of digitoxin were not achieved in subjects until relatively late the in 28 day treatment period. This would suggest that it may require a much longer treatment course to meaningfully effect inflammation in the airways.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | The Il-8 measurements of sputum digitoxin levels for each group is shown for 5 days (Days 1, 14, 21, 28 and 42). |
| Primary | Change in Il-8 (Interleukin 8) Levels From Day 28 Minus Day 1 (Treatment Period). | 28 days (Day 28 minus Day 1) | Change in Il-8 values are expressed as a change in log 10 Il-8 pg/mL from Day 28 minus Day 1. |
| Primary | Effect of Digitoxin on Neutrophil Counts in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | 42 days (Day 1- Day 42) | 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). |
| Primary | Change in Neutrophil Cell Count Day 28 Minus Day 1 (Treatment Period). | 28 days (Day 28 minus Day 1) | 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). |
| Secondary | Pharmacokinetics (PK) of Digitoxin in Serum in Stable CF Patients. | Serum PK on Days 1 (pre-dose), 7, 14, 21 and 42 | Digitoxin serum levels were drawn on Days 1 (pre-dose), 7, 14, 21 and 42. The range of digitoxin levels for each visit is listed and the number of subjects who had that level are marked by group (placebo, low dose and high dose). |
| Secondary | Safety Indices Including Change in FEV1 in Stable CF Patients. | Baseline and Day 28 | Safety indices included changes in FEV1 (forced expiratory volume in 1 second), changes in WBC (white blood cell count), alterations in ECG and sputum microbiology. The median changes in FEV1 are reported. |
| 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 | CFQ-R is a disease-specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms. Developed specifically for use in patients with a diagnosis of cystic fibrosis. There are 9 Quality of life domains: physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions and 3 symptom scales: weight, respiratory, and digestion. Scaling of items is done via 5 distinct 4-point Likert scales. Scores for each domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health. Based on clinician judgment of global clinical change, a moderate change was a standardized effect size of 0.50 units and an important change was a standardized effect size of 0.80 units evaluating pre- and post-treatment for CF exacerbation. Mean changes in CFQ-R Scores by Group were evaluated between Visit 6 and Visit 1, by Domain. |
| Secondary | Change in WBC (White Blood Cell) Count by Group During Treatment Period | Baseline and Day 28 | Safety indices included changes in FEV1 (lung function), changes in WBC, alterations in ECG and sputum microbiology. There were no significant alterations in the ECG in any subjects over the course of the study. There were no subjects who acquired multiple resistant changes in microbiology of sputum and no acquisition of B. cepacia in any subjects. Therefore, these data were not analyzed. The median changes in FEV1 and median changes in WBC, ESR and CRP are reported. |
| Secondary | Changes in C Reactive Protein (CRP) During Treatment. | Baseline and Day 28 | Median changes in CRP and IQR were assessed from serum samples collected at Visits 1,3, 4 and 5. |
| Secondary | Changes in Erythrocyte Sedimentation Rate (ESR) During Treatment Period. | Baseline and Day 28 | Median change in serum ESR (mm/hr) and IQR was calculated from Treatment Period (28 days). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group190
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | Placebo | IL-8 Day 1 | 4.59 | Inter-Quartile Range 4.15 to 5.12 | log 10 (pg/mL) |
| Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | Low Dose 0.05 mg Digitoxin | IL-8 Day 1 | 4.96 | Inter-Quartile Range 4.4 to 5.18 | log 10 (pg/mL) |
| Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | Higher Dose 0.1mg Digitoxin | IL-8 Day 1 | 5.04 | Inter-Quartile Range 4.58 to 5.10 | log 10 (pg/mL) |
| Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | Placebo | IL-8 Day 14 | 4.94 | Inter-Quartile Range 4.21 to 5.34 | log 10 (pg/mL) |
| Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | Low Dose 0.05 mg Digitoxin | IL-8 Day 14 | 4.89 | Inter-Quartile Range 4.50 to 5.01 | log 10 (pg/mL) |
| Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | Higher Dose 0.1mg Digitoxin | IL-8 Day 14 | 5.01 | Inter-Quartile Range 4.66 to 5.45 | log 10 (pg/mL) |
| Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | Placebo | IL-8 Day 21 | 5.08 | Inter-Quartile Range 4.21 to 5.38 | log 10 (pg/mL) |
| Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | Low Dose 0.05 mg Digitoxin | IL-8 Day 21 | 4.77 | Inter-Quartile Range 4.64 to 4.89 | log 10 (pg/mL) |
| Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | Higher Dose 0.1mg Digitoxin | IL-8 Day 21 | 5.17 | Inter-Quartile Range 4.66 to 5.42 | log 10 (pg/mL) |
| Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. | Placebo | IL-8 Day 28 | 4.66 | Inter-Quartile Range 4.49 to 5.38 | log 10 (pg/mL) |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | STARTED | Low Dose 0.05mg Digitoxin | 8 | |
| Overall Study | STARTED | Higher Dose 0.1mg Digitoxin | 8 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | COMPLETED | Low Dose 0.05mg Digitoxin | 8 | |
| Overall Study | COMPLETED | Higher Dose 0.1mg Digitoxin | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Low Dose 0.05mg Digitoxin | 0 | |
| Overall Study | NOT COMPLETED | Higher Dose 0.1mg Digitoxin | 0 |
Source ClinicalTrials.gov
Adverse events111
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | abdominal pain | Gastrointestinal disorders | Placebo | 2 | 8 | 4 |
| other | abdominal pain | Gastrointestinal disorders | Low Dose 0.05 mg Digitoxin | 1 | 8 | 1 |
| other | abdominal pain | Gastrointestinal disorders | Higher Dose 0.1mg Digitoxin | 1 | 8 | 1 |
| other | anxiety | Nervous system disorders | Placebo | 0 | 8 | 0 |
| other | anxiety | Nervous system disorders | Low Dose 0.05 mg Digitoxin | 1 | 8 | 1 |
| other | anxiety | Nervous system disorders | Higher Dose 0.1mg Digitoxin | 0 | 8 | 0 |
| other | chills | Infections and infestations | Placebo | 1 | 8 | 1 |
| other | chills | Infections and infestations | Low Dose 0.05 mg Digitoxin | 0 | 8 | 0 |
| other | chills | Infections and infestations | Higher Dose 0.1mg Digitoxin | 0 | 8 | 0 |
| other | cough | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 8 | 2 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Low Dose 0.05 mg Digitoxin | ||
| Total, all-cause mortality | Higher Dose 0.1mg Digitoxin | ||
| Total, other adverse events | Placebo | 7 | 8 |
| Total, other adverse events | Low Dose 0.05 mg Digitoxin | 5 | 8 |
| Total, other adverse events | Higher Dose 0.1mg Digitoxin | 6 | 8 |
| Total, serious adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Low Dose 0.05 mg Digitoxin | 0 | 8 |
| Total, serious adverse events | Higher Dose 0.1mg Digitoxin | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28006108 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
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