Cystic FibrosisPhase 2NCT00782288

Phase II Study of Digitoxin to Treat Cystic Fibrosis

A Phase 2 study testing digitoxin in people with Cystic Fibrosis, run by National Jewish Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will measure the inflammatory effects of digitoxin on IL-8 and neutrophil counts in induced sputum in stable Cystic Fibrosis (CF) patients and the pharmacokinetics of digitoxin in serum. Funding Source-FDA OOPD Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Cystic Fibrosis
What is being tested?: digitoxin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Aug 2010to Aug 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female 18-45 years of age
Confirmed diagnosis of CF based on the following criteria:positive sweat chloride > or = 60 mEq/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF
FEV1 > or = 40% predicted value at screening
Weight > 45 kg at Screening and Visit 1 (dosing)
Clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation (see Appendix II) or treatment of a pulmonary exacerbation within the 14 days prior to Screen Visit. Subject may rescreen 14 days after they complete treatment for a pulmonary exacerbation, if healthy at that time.
Ability to perform Spirometry.
Ability to understand and sign a written informed consent and comply with the requirements of the study.

Who cannot join

Use of an investigational agent within the 4-week period prior to Screen visit.
Use of a medication with anti-neutrophil or anti-inflammatory effect or those known to have an effect on inflammatory outcomes [azithromycin, gentamicin, amikacin, colistin, ibuprofen, celecoxib, or other NSAIDs, prednisone or other corticosteroids(systemic or inhaled), such as Advair, cromolyn (Intal®), montelukast (Singulair®), zafirlukast (Accolate®), zileuton (Zyflo®), and any immunosuppressive agent within the 4 weeks prior to Visit #1, Day 1 and until their participation in the study ends (after Visit 6). See NOTE at end of exclusionary criteria for subjects on oral antibiotic therapy.
Use of topical nasal steroid products for at least 2 weeks prior to study drug administration and discontinued use until after the nasal cell collection at Day 28.
Inability or unwillingness to stop macrolide antibiotics 4 weeks prior to Day 1 until their participation in the study ends. Prior use of macrolide antibiotics, including those for maintenance therapy will not exclude the subject from participation.
History of significant cardiac disease or cardiac arrhythmia
Presence of an arrhythmia identified on screening ECG or 24 hour holter monitor

Show all 23Show fewer

Pulmonary hypertension
History of significant cardiac disease or cardiac arrhythmia
Presence of a clinically significant arrhythmia identified on screening ECG or 24 hour holter monitor.
Pulmonary hypertension
Burkholderia species in sputum within 2 years or at Screen visit
Drugs known to interact with digitoxin including phenobarbital, amphotericin B, rifampicin, diltiazem, and verapamil or drugs that would potentiate potassium loss (certain diuretics or excessive laxative use, defined as more than twice daily use of miralax).
Unwillingness to use beta-agonists (or levalbuterol) prior to induced sputum procedures.
Oxygen saturation < 92% on room air at Screen visit
Pregnant, breastfeeding, or unwilling to use an effective form of birth control for the duration of the study
History of significant hemoptysis > or = 60cc per episode during the 30 days prior to Screening visit
Significant history of hepatic, cardiovascular, renal, neurological, hematologic, or peptic ulcer disease
SGOT (ALT) or SGPT (AST) > 3 times the upper limit of normal at Screen, documented biliary cirrhosis, or portal hypertension
Creatinine > 1.8 mg/dL at Screen
Inability to swallow pills
Potassium, serum <3.3 mEq/L at screening
Known inability to produce sputum (if unable to expectorate, must be able to produce an induced sputum sample at screening).
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data NOTE: For subjects on continuous antibiotic therapy for at least 6 months one continuous antibiotic or alternating two different antibiotics, they can maintain their current therapy. If the subject is alternating between two different inhaled antibiotics each month, Visit 1 should coincide with the "on" cycle of one of the inhaled antibiotics for consistency during the treatment period. For subjects on alternate month TOBI®, colistin or Cayston therapy, the "off" cycle must coincide with the Treatment Phase of the study. Subjects should be scheduled for Screening Visit during their one-month "on" period, and may resume taking TOBI®, colistin or Cayston after completion of Visit 6 (Day 42) or early termination.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Hospital
Baltimore, Maryland, 21287

Other trials in United States

About this study

This study will measure the inflammatory effects of digitoxin on IL-8 and neutrophil counts in induced sputum in stable Cystic Fibrosis (CF) patients and the pharmacokinetics of digitoxin in serum.

Funding Source-FDA OOPD

Read the detailed description

The study will be conducted as a randomized, double blind, placebo-controlled, repeat dosing trial evaluating the effects of 28 days of digitoxin on IL-8 and neutrophil concentrations in induced sputum in subjects with mild to moderate cystic fibrosis lung disease. Twenty-four total patients will be randomized into 3 groups of 8 subjects each (0.05 mg or 0.1 mg digitoxin or a placebo).

Conditions: Cystic Fibrosis
Being tested: digitoxin, placebo
Keywords: digitoxin, inflammatory markers, cytokines, gene expression
Medical subject headings: Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

digitoxinDrug
0.05mg tabs, once daily for 28 days
digitoxinDrug
0.1mg pills, once daily for 28 days.
placeboOther
pill taken once daily for 28 days

Study groups in NCT00782288
Study group	Role	What they receive
1	Active comparator	low dose 0.05mg digitoxin given once daily for 28 days Receives: Drug: digitoxin
2	Active comparator	higher dose 0.1mg digitoxin daily for 28 days Receives: Drug: digitoxin
3	Placebo comparator	placebo given daily for 28 days Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 28 days (Day 28 minus Day 1)

Secondary outcomes (9)

Pharmacokinetics (PK) of Digitoxin in Serum in Stable CF Patients.
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).
Measured: Serum PK on Days 1 (pre-dose), 7, 14, 21 and 42
Safety Indices Including Change in FEV1 in Stable CF Patients.
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.
Measured: Baseline and Day 28
Mean Change in Quality of Life Scores, for Each Domain, From Day 1 to Day 42 Using the Cystic Fibrosis Questionnaire Revised (CFQ-R).
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.
Measured: Baseline and Day 42
Change in WBC (White Blood Cell) Count by Group During Treatment Period
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.
Measured: Baseline and Day 28
Changes in C Reactive Protein (CRP) During Treatment.
Median changes in CRP and IQR were assessed from serum samples collected at Visits 1,3, 4 and 5.
Measured: Baseline and Day 28
Changes in Erythrocyte Sedimentation Rate (ESR) During Treatment Period.
Median change in serum ESR (mm/hr) and IQR was calculated from Treatment Period (28 days).
Measured: Baseline and Day 28
Number of CF Subjects With Microarray Results From Nasal Epithelial Cells to Measure the Effect of Digitoxin on Gene Expression.
Rhinoprobe was used to collect nasal epithelial cells. The cells were collected pre and post-treatment and placed in Trizol for RNA isolation then used to measure the effect of digitoxin on gene expression. The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). The accession number for that data is GSE76347 (data available Dec 2018).
Measured: Day 0 and Day 28
Clinically Significant Alterations in ECG Readings
Safety indices included an assessment for the number of clinically significant alterations in the subjects ECG readings from Day 1 to Day 28.
Measured: 28 days
Clinically Significant Changes in the Microbiology of Sputum in Subjects
Count of clinically significant changes in sputum microbiology during the Treatment phase (Day 1 to Day 28) to include any new acquisition of B. cepacia or new acquisition of any multiple resistant organism.
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Aug 2016

First posted31 Oct 2008 (estimated)
Study startAug 2010
Primary completionAug 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cystic FibrosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00782288
Sponsor's protocol ID: FD-R-003456-01
Status last verified: Mar 2019
First submitted: 29 Oct 2008
Last updated: 21 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Zeitlin PL, Diener-West M, Callahan KA, Lee S, Talbot CC Jr, Pollard B, Boyle MP, Lechtzin N. Digitoxin for Airway Inflammation in Cystic Fibrosis: Preliminary Assessment of Safety, Pharmacokinetics, and Dose Finding. Ann Am Thorac Soc. 2017 Feb;14(2):220-229. doi: 10.1513/AnnalsATS.201608-649OC.
PubMed 28006108

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Digitoxin to Treat Cystic Fibrosis
ClinicalTrials.gov ID: NCT00782288
Acronym / sponsor ID: FD-R-003456-01
Conditions: Cystic Fibrosis
Keywords: digitoxin, inflammatory markers, cytokines, gene expression
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: National Jewish HealthUniversity, hospital or other
Study start: Aug 2010
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 31 Oct 2008 (estimated)
Results: Posted 22 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will measure the inflammatory effects of digitoxin on IL-8 and neutrophil counts in induced sputum in stable Cystic Fibrosis (CF) patients and the pharmacokinetics of digitoxin in serum.

Funding Source-FDA OOPD

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
1	Active comparator	Drug: digitoxinlow dose 0.05mg digitoxin given once daily for 28 days
2	Active comparator	Drug: digitoxinhigher dose 0.1mg digitoxin daily for 28 days
3	Placebo comparator	Other: placeboplacebo given daily for 28 days

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Male or female 18-45 years of age
Confirmed diagnosis of CF based on the following criteria:positive sweat chloride > or = 60 mEq/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF
FEV1 > or = 40% predicted value at screening
Weight > 45 kg at Screening and Visit 1 (dosing)
Clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation (see Appendix II) or treatment of a pulmonary exacerbation within the 14 days prior to Screen Visit. Subject may rescreen 14 days after they complete treatment for a pulmonary exacerbation, if healthy at that time.

Key exclusion criteria (23 listed)

Use of an investigational agent within the 4-week period prior to Screen visit.
Use of a medication with anti-neutrophil or anti-inflammatory effect or those known to have an effect on inflammatory outcomes [azithromycin, gentamicin, amikacin, colistin, ibuprofen, celecoxib, or other NSAIDs, prednisone or other corticosteroids(systemic or inhaled), such as Advair, cromolyn (Intal®), montelukast (Singulair®), zafirlukast (Accolate®), zileuton (Zyflo®), and any immunosuppressive agent within the 4 weeks prior to Visit #1, Day 1 and until their participation in the study ends (after Visit 6). See NOTE at end of exclusionary criteria for subjects on oral antibiotic therapy.
Use of topical nasal steroid products for at least 2 weeks prior to study drug administration and discontinued use until after the nasal cell collection at Day 28.
Inability or unwillingness to stop macrolide antibiotics 4 weeks prior to Day 1 until their participation in the study ends. Prior use of macrolide antibiotics, including those for maintenance therapy will not exclude the subject from participation.
History of significant cardiac disease or cardiac arrhythmia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
digitoxin0.05mg tabs, once daily for 28 days	Drug	1
digitoxin0.1mg pills, once daily for 28 days.	Drug	2
placebopill taken once daily for 28 days	Other	3

Primary outcome

Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.
Time frame: 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).
Change in Il-8 (Interleukin 8) Levels From Day 28 Minus Day 1 (Treatment Period).
Time frame: 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.
Effect of Digitoxin on Neutrophil Counts in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.
Time frame: 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).
Change in Neutrophil Cell Count Day 28 Minus Day 1 (Treatment Period).
Time frame: 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).

9 secondary outcomes

Pharmacokinetics (PK) of Digitoxin in Serum in Stable CF Patients.
Time frame: Serum PK on Days 1 (pre-dose), 7, 14, 21 and 42
Safety Indices Including Change in FEV1 in Stable CF Patients.
Time frame: Baseline and Day 28
Mean Change in Quality of Life Scores, for Each Domain, From Day 1 to Day 42 Using the Cystic Fibrosis Questionnaire Revised (CFQ-R).
Time frame: Baseline and Day 42
Change in WBC (White Blood Cell) Count by Group During Treatment Period
Time frame: Baseline and Day 28
Changes in C Reactive Protein (CRP) During Treatment.
Time frame: Baseline and Day 28
Changes in Erythrocyte Sedimentation Rate (ESR) During Treatment Period.
Time frame: Baseline and Day 28
Number of CF Subjects With Microarray Results From Nasal Epithelial Cells to Measure the Effect of Digitoxin on Gene Expression.
Time frame: Day 0 and Day 28
Clinically Significant Alterations in ECG Readings
Time frame: 28 days
Clinically Significant Changes in the Microbiology of Sputum in Subjects
Time frame: 28 days

Results and safety

Results posted to the registry on 22 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	8	8
Low Dose 0.05mg Digitoxin	8	8
Higher Dose 0.1mg Digitoxin	8	8

Primary outcome: Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.

Time frame: 42 days (Day 1 to Day 42). Median (Inter-Quartile Range). Unit: log 10 (pg/mL)

Measure	Placebo n = 8	Low Dose 0.05 mg Digitoxin n = 8	Higher Dose 0.1mg Digitoxin n = 8
IL-8 Day 1	4.59 (4.15 to 5.12)	4.96 (4.4 to 5.18)	5.04 (4.58 to 5.10)
IL-8 Day 14	4.94 (4.21 to 5.34)	4.89 (4.50 to 5.01)	5.01 (4.66 to 5.45)
IL-8 Day 21	5.08 (4.21 to 5.38)	4.77 (4.64 to 4.89)	5.17 (4.66 to 5.42)
IL-8 Day 28	4.66 (4.49 to 5.38)	4.79 (4.49 to 4.91)	5.20 (4.68 to 5.34)
IL-8 Day 42	4.59 (4.22 to 5.06)	4.74 (4.62 to 5.04)	4.97 (4.43 to 5.25)

Placebo vs Low Dose 0.05 mg Digitoxin vs Higher Dose 0.1mg Digitoxin: p >0.05, Wilcoxon (Mann-Whitney)

Population analysed: 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.

Primary outcome: Change in Il-8 (Interleukin 8) Levels From Day 28 Minus Day 1 (Treatment Period).

Time frame: 28 days (Day 28 minus Day 1). Median (Inter-Quartile Range). Unit: log10 (pg/mL)

Measure	Placebo n = 8	Low Dose 0.05mg Digitoxin n = 8	Higher Dose 0.1mg Digitoxin n = 8
Value	0.13 (0.06 to 0.40)	-0.13 (-0.23 to 0.16)	0.04 (-0.24 to 0.41)

Population analysed: For change in Il-8 from Day 28 minus Day 1, a Kruskal-Wallis equality of populations rank was performed.

Primary outcome: Effect of Digitoxin on Neutrophil Counts in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.

Time frame: 42 days (Day 1- Day 42). Median (Inter-Quartile Range). Unit: log 10 (neutrophil cells/mL)

Measure	Placebo n = 8	Low Dose 0.05 mg Digitoxin n = 7	Higher Dose 0.1mg Digitoxin n = 7
Day 1	2.58 (1.89 to 3.00)	2.82 (1.88 to 3.08)	2.93 (2.35 to 3.04)
Day 14	2.89 (2.18 to 2.92)	2.26 (1.35 to 2.91)	2.71 (2.26 to 3.10)
Day 21	2.86 (2.44 to 3.35)	2.23 (1.52 to 2.62)	2.88 (1.90 to 3.14)
Day 28	2.71 (2.16 to 3.06)	2.16 (0.83 to 2.64)	2.77 (1.97 to 3.01)
Day 42	2.55 (2.27 to 2.81)	2.06 (1.58 to 2.35)	2.82 (2.00 to 2.96)

Placebo vs Low Dose 0.05 mg Digitoxin vs Higher Dose 0.1mg Digitoxin: p >0.05, Wilcoxon (Mann-Whitney)

Population analysed: 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.

Primary outcome: Change in Neutrophil Cell Count Day 28 Minus Day 1 (Treatment Period).

Time frame: 28 days (Day 28 minus Day 1). Median (Inter-Quartile Range). Unit: log 10 (neutrophil cell/mL)

Measure	Placebo n = 8	Low Dose 0.05mg Digitoxin n = 7	Higher Dose 0.1mg Digitoxin n = 7
Value	0.19 (-0.24 to 0.82)	-0.26 (-0.41 to 0.29)	-0.02 (-0.33 to 0.26)

Population analysed: 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).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from Screening through Day 42 or the Early Withdraw Visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
Low Dose 0.05 mg Digitoxin	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
Higher Dose 0.1mg Digitoxin	0 of 8 (0%)	6 of 8 (75%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28006108Zeitlin PL, Diener-West M, Callahan KA, Lee S, Talbot CC Jr, Pollard B, Boyle MP, Lechtzin N. Digitoxin for Airway Inflammation in Cystic Fibrosis: Preliminary Assessment of Safety, Pharmacokinetics, and Dose Finding. Ann Am Thorac Soc. 2017 Feb;14(2):220-229. doi: 10.1513/AnnalsATS.201608-649OC.
Johns Hopkins Cystic Fibrosis websiteLink provided by the sponsor.
Cystic Fibrosis Foundation websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pamela L Zeitlin, MD, PhD principal investigator

Johns Hopkins University, School of Medicine, Pediatric Pulmonary

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing digitoxin in people with Cystic Fibrosis, run by National Jewish Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients. (time frame: 42 days (Day 1 to Day 42)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00782288, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.