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Phase II Study of Digitoxin to Treat Cystic Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00782288
First Posted: October 31, 2008
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pam Zeitlin, National Jewish Health
Results First Submitted: October 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Interventions: Drug: digitoxin
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All participants were recruited from the Johns Hopkins University in Baltimore, Maryland. The first participant was enrolled on October 13, 2010 and the last participant was enrolled on May 6, 2014. All study visits were completed as of June 2014. There was a DSMB safety review prior to enrolling any subjects into the higher dose group (0.1 mg).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were all consented on a Johns Hopkins IRB approved consent form and screened 2 or 4 weeks prior to enrollment. Enrollment was contingent on meeting all inclusion/exclusion criteria.

Reporting Groups
  Description
Placebo

placebo given daily for 28 days

placebo: pill taken once daily for 28 days

Low Dose 0.05mg Digitoxin

low dose 0.05mg digitoxin given once daily for 28 days

digitoxin: 0.05mg tabs, once daily for 28 days

Higher Dose 0.1mg Digitoxin

higher dose 0.1mg digitoxin daily for 28 days

digitoxin: 0.1mg pills, once daily for 28 days.


Participant Flow:   Overall Study
    Placebo   Low Dose 0.05mg Digitoxin   Higher Dose 0.1mg Digitoxin
STARTED   8   8   8 
COMPLETED   8   8   8 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

placebo given daily for 28 days

placebo: pill taken once daily for 28 days

Low Dose 0.05 mg Digitoxin

low dose 0.05mg digitoxin given once daily for 28 days

digitoxin: 0.05mg tabs, once daily for 28 days

Higher Dose 0.1mg Digitoxin

higher dose 0.1mg digitoxin daily for 28 days

digitoxin: 0.1mg pills, once daily for 28 days.

Total Total of all reporting groups

Baseline Measures
   Placebo   Low Dose 0.05 mg Digitoxin   Higher Dose 0.1mg Digitoxin   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   8   24 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      8 100.0%      8 100.0%      8 100.0%      24 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 24.8 
 (18.2 to 39.7) 
 23.5 
 (18.2 to 37.7) 
 30.3 
 (19.8 to 42.8) 
 26.2 
 (18.2 to 42.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      4  50.0%      5  62.5%      4  50.0%      13  54.2% 
Male      4  50.0%      3  37.5%      4  50.0%      11  45.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      8 100.0%      8 100.0%      8 100.0%      24 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   8   8   8   24 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Primary:   Change in Il-8 (Interleukin 8) Levels From Day 28 Minus Day 1 (Treatment Period).   [ Time Frame: 28 days (Day 28 minus Day 1) ]

3.  Primary:   Effect of Digitoxin on Neutrophil Counts in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.   [ Time Frame: 42 days (Day 1- Day 42) ]

4.  Primary:   Change in Neutrophil Cell Count Day 28 Minus Day 1 (Treatment Period).   [ Time Frame: 28 days (Day 28 minus Day 1) ]

5.  Secondary:   Pharmacokinetics (PK) of Digitoxin in Serum in Stable CF Patients.   [ Time Frame: Serum PK on Days 1 (pre-dose), 7, 14, 21 and 42 ]

6.  Secondary:   Safety Indices Including Change in FEV1 in Stable CF Patients.   [ Time Frame: Baseline and Day 28 ]

7.  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).   [ Time Frame: Baseline and Day 42 ]

8.  Secondary:   Change in WBC (White Blood Cell) Count by Group During Treatment Period   [ Time Frame: Baseline and Day 28 ]

9.  Secondary:   Changes in C Reactive Protein (CRP) During Treatment.   [ Time Frame: Baseline and Day 28 ]

10.  Secondary:   Changes in Erythrocyte Sedimentation Rate (ESR) During Treatment Period.   [ Time Frame: Baseline and Day 28 ]

11.  Secondary:   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 ]

12.  Secondary:   Clinically Significant Alterations in ECG Readings   [ Time Frame: 28 days ]

13.  Secondary:   Clinically Significant Changes in the Microbiology of Sputum in Subjects   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Pamela L. Zeitlin, M.D., Ph.D., Professor and Director of SOM Pediatric Pulmonary
Organization: Johns Hopkins University
phone: 443-287-8981
e-mail: pzeitlin@jhmi.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pam Zeitlin, National Jewish Health
ClinicalTrials.gov Identifier: NCT00782288     History of Changes
Other Study ID Numbers: FD-R-003456-01
First Submitted: October 29, 2008
First Posted: October 31, 2008
Results First Submitted: October 14, 2015
Results First Posted: January 22, 2016
Last Update Posted: September 14, 2017