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Oral Cyclosporine in Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT00974142
Recruitment Status : Completed
First Posted : September 10, 2009
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michael Donahoe, University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Cyclosporine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from local clinics, advertisement, and a disease specific registry

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
772 patients underwent initial screening and 43 were eligible to sign consent. These patients underwent a second 2 week screening process and 17 subjects met all criteria for randomization

Reporting Groups
  Description
Cyclosporine Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
Placebo Randomized to placebo capsules identical in appearance to cyclosporine

Participant Flow:   Overall Study
    Cyclosporine   Placebo
STARTED   8   9 
COMPLETED   8   9 
NOT COMPLETED   0   0 



  Baseline Characteristics

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
Cyclosporine Randomized post 2nd level screen to 3 mg/kg / day oral cyclosporine
Placebo Randomized to placebo capsules identical in appearance to cyclosporine
Total Total of all reporting groups

Baseline Measures
   Cyclosporine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   9   17 
Age 
[Units: Years]
Median (Full Range)
 68 
 (55 to 79) 
 63 
 (48 to 77) 
 67 
 (48 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  25.0%      4  44.4%      6  35.3% 
Male      6  75.0%      5  55.6%      11  64.7% 
Forced Vital Capacity (%) 
[Units: % predicted]
Median (Inter-Quartile Range)
 88 
 (71 to 105) 
 77 
 (60 to 94) 
 79 
 (60 to 105) 
Forced Expiratory Volume 1 second (%) 
[Units: % predicted]
Median (Full Range)
 38 
 (31 to 54) 
 43 
 (27 to 58) 
 39 
 (27 to 58) 
Functional Residual Capacity (%) 
[Units: % predicted]
Median (Full Range)
 146 
 (108 to 180) 
 149 
 (81 to 170) 
 149 
 (81 to 180) 
Total Lung Capacity (%) 
[Units: % predicted]
Median (Full Range)
 123 
 (100 to 145) 
 119 
 (84 to 138) 
 119 
 (84 to 145) 
Partial pressure of carbon dioxide (pCO2) 
[Units: Mm Hg]
Mean (Standard Deviation)
 40  (3.6)   42.6  (3.9)   41.2  (3.7) 
Partial pressure of oxygen (pO2) 
[Units: Mm Hg]
Mean (Standard Deviation)
 71  (11)   76  (20)   74  (15) 
Weight 
[Units: Kilograms]
Median (Full Range)
 83 
 (60 to 105) 
 93 
 (55 to 119) 
 84 
 (55 to 119) 
Systolic blood pressure (mm Hg) 
[Units: Mm Hg]
Median (Full Range)
 141 
 (125 to 152) 
 133 
 (104 to 150) 
 138 
 (104 to 152) 
Diastolic blood pressure (mm Hg) 
[Units: Mm Hg]
Median (Full Range)
 82 
 (71 to 95) 
 78 
 (70 to 91) 
 79 
 (70 to 95) 
White blood cell count 
[Units: x10E ^09/L]
Mean (Standard Deviation)
 7.3  (1.3)   6.6  (2.0)   7.1  (2.2) 
Hemoglobin 
[Units: Grams / dL]
Mean (Standard Deviation)
 13.7  (1.0)   13.6  (0.9)   13.7  (1.03) 
Blood Urea Nitrogen 
[Units: Mg / dL]
Mean (Standard Deviation)
 16  (5.4)   13  (3.2)   13.4  (3.9) 
Creatinine 
[Units: Mg / dL]
Mean (Standard Deviation)
 0.9  (0.2)   0.9  (0.2)   0.9  (0.2) 
Glucose 
[Units: Mg / dL]
Mean (Standard Deviation)
 102  (13)   113  (29)   111  (29) 
Cholesterol 
[Units: Mg / dL]
Mean (Standard Deviation)
 183  (30)   193  (20)   183  (20) 


  Outcome Measures

1.  Primary:   Safety Profile of Oral Cyclosporin A Immunotherapy in Advanced Stage Chronic Obstructive Pulmonary Disease Patients- Nephrotoxicity - Measured by Serum Creatinine   [ Time Frame: 16 weeks ]

2.  Primary:   Safety Profile of Oral Cyclosporin A Immunotherapy in Advanced Stage Chronic Obstructive Pulmonary Disease Patients - Number of Patients That Developed Renal Insufficiency   [ Time Frame: 16 weeks ]

3.  Primary:   Safety Profile of Oral Cyclosporin A Immunotherapy in Advanced Stage Chronic Obstructive Pulmonary Disease Patients - Number of Patients That Developed Infection Requiring Systemic Antibiotic Therapy   [ Time Frame: 16 weeks ]

4.  Secondary:   Pharmacokinetic - Pharmacodynamic Relationship of Oral Cyclosporine and Biomarkers of an Adaptive Immune Response - Cyclosporine Blood Levels   [ Time Frame: 16 weeks ]

5.  Secondary:   Peripheral Blood T Cell Biomarkers Over 16 Week Treatment Interval - Change in the Percentage of Cluster of Differentiation 4 (CD4)   [ Time Frame: at Week 8 and Week 16 ]

6.  Secondary:   Peripheral Blood T Cell Biomarkers Over 16 Week Treatment Interval - Change in the Percentage of Cluster of Differentiation 8 and Cluster of Differentiation 28   [ Time Frame: at Week 8 and Week 16 ]

7.  Secondary:   Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 8 and Major Histocompatibility Complex II   [ Time Frame: at Week 8 and Week 16 ]

8.  Secondary:   Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 8+ Interferon Gamma   [ Time Frame: at Week 8 and Week 16 ]

9.  Secondary:   Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 4+ Interleukin-2   [ Time Frame: at Week 8 and Week 16 ]

10.  Secondary:   Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 8+ Tumor Necrosis Factor   [ Time Frame: at Week 8 and Week 16 ]

11.  Secondary:   Effects of Cyclosporin A on Respiratory Function - Change in the Percentage of Post Predicted Value of Forced Vital Capacity   [ Time Frame: at Week 8 and Week 16 ]

12.  Secondary:   Effects of Cyclosporin A on Respiratory Function - Change in the Percentage of Post Predicted Value of Forced Expiratory Volume in 1 Second   [ Time Frame: at Week 8 and Week 16 ]

13.  Secondary:   Effects of Cyclosporin A on Respiratory Function - Change in Exercise Capacity by a Shuttle Walk Distance Measured in Feet   [ Time Frame: at Week 8 and Week 16 ]

14.  Secondary:   Effects of Cyclosporin A on Symptoms - Change in Scores on a Shortness of Breath Scale   [ Time Frame: at Week 8 and Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael Donahoe MD
Organization: University of Pittsburgh Medical Center
phone: 412-648-9636
e-mail: donahoem@upmc.edu



Responsible Party: Michael Donahoe, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00974142     History of Changes
Other Study ID Numbers: PRO09050330
First Submitted: September 9, 2009
First Posted: September 10, 2009
Results First Submitted: January 3, 2018
Results First Posted: May 9, 2018
Last Update Posted: May 9, 2018