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Targeting Oxidative Stress in Chronic Beryllium Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01088243
First Posted: March 17, 2010
Last Update Posted: December 12, 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):
Lisa Maier, National Jewish Health
Results First Submitted: September 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Beryllium Disease
Interventions: Drug: Mesalamine
Drug: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mesalamine

Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.

Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.

Placebo

Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.

Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.


Participant Flow:   Overall Study
    Mesalamine   Placebo
STARTED   13   5 
COMPLETED   12   5 
NOT COMPLETED   1   0 
Adverse Event                1                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
Mesalamine

Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.

Mesalamine: Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.

Placebo

Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.

Placebo: Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.

Total Total of all reporting groups

Baseline Measures
   Mesalamine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   5   18 
Age 
[Units: Years]
Mean (Full Range)
 63.3 
 (53 to 74) 
 62.8 
 (49 to 79) 
 63.16 
 (49 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  15.4%      1  20.0%      3  16.7% 
Male      11  84.6%      4  80.0%      15  83.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   13   5   18 
Smoking Status 
[Units: Count of Participants]
     
Never   5   2   7 
Former   8   3   11 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6   [ Time Frame: baseline and week 6 ]

2.  Secondary:   Changes in Bronchoalveolar Lavage (BAL) Tumor Necrosis Factor Alpha (TNFa)   [ Time Frame: baseline and week 6 ]

3.  Secondary:   Changes in Steady-state Glutathione (GSH) Levels From Baseline to Week 6   [ Time Frame: baseline and week 6 ]

4.  Secondary:   HDAC2 Levels   [ Time Frame: baseline and week 6 ]

5.  Secondary:   Glucocorticoid Receptors   [ Time Frame: baseline and week 6 ]

6.  Secondary:   Lung Function   [ Time Frame: baseline and week 6 ]


  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
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  More Information
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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: Dr. Lisa A. Maier
Organization: National Jewish Health
phone: 303-398-1983
e-mail: MaierL@NJHealth.org



Responsible Party: Lisa Maier, National Jewish Health
ClinicalTrials.gov Identifier: NCT01088243     History of Changes
Other Study ID Numbers: HS-2360B
First Submitted: March 15, 2010
First Posted: March 17, 2010
Results First Submitted: September 14, 2017
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017