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Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Francisco
University of Chicago
University of Illinois at Chicago
University of Michigan
Columbia University
Tulane University
University of Washington
Information provided by (Responsible Party):
Ivan O. Rosas, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01214187
First received: September 30, 2010
Last updated: May 18, 2017
Last verified: May 2017
Results First Received: March 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider;   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Interventions: Drug: inhaled carbon monoxide
Other: Oxygen

  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
The enrollment period opened on 11/29/2011 and was closed on 1/10/2014 when the study reached its enrollment target of 58 subjects. Subjects were enrolled at 8 participating academic medical centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Sixty-five subjects were screened, of which 7 subjects were screen failures. Reasons for screen failure included subjects who completed screening changed their mind about participation before visit 2, FEV1/FVC less than 70% predicted, and infection within 1 month before screening. The screening period up to 28 days from date of consent to Visit 2.

Reporting Groups
  Description
Carbon Monoxide Inhalation

The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.

inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.

Oxygen 21% Oxygen: Room air oxygen concentrations will be administered as placebo

Participant Flow:   Overall Study
    Carbon Monoxide Inhalation   Oxygen 21%
STARTED   29   29 
COMPLETED   22   23 
NOT COMPLETED   7   6 
Adverse Event                6                2 
Death                1                1 
Withdrawal by Subject                0                3 



  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
Carbon Monoxide Inhalation

The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.

inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.

Oxygen 21% Oxygen: Room air oxygen concentrations will be administered as placebo
Total Total of all reporting groups

Baseline Measures
   Carbon Monoxide Inhalation   Oxygen 21%   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   29   58 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.6  (6.1)   68.6  (8.4)   68  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  13.8%      7  24.1%      11  19.0% 
Male      25  86.2%      22  75.9%      47  81.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   3.4%      2   6.9%      3   5.2% 
Not Hispanic or Latino      28  96.6%      27  93.1%      55  94.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   29   29   58 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Serum MMP7 Level   [ Time Frame: Baseline to Week 12 ]

2.  Secondary:   Total Lung Capacity % Predicted Values (TLC)   [ Time Frame: Baseline to Week 12 ]

3.  Secondary:   Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values   [ Time Frame: Baseline to Week 12 ]

4.  Secondary:   Six Minute Walk Distance   [ Time Frame: Baseline to Week 12 ]

5.  Secondary:   St George's Respiratory Questionnaire   [ Time Frame: Baseline to Week 12 ]


  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: Ivan Rosas, MD
Organization: Brigham and Women's Hospital
phone: 617-278-0434
e-mail: irosas@rics.bwh.harvard.edu



Responsible Party: Ivan O. Rosas, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01214187     History of Changes
Other Study ID Numbers: 1U01HL105371 ( U.S. NIH Grant/Contract )
Study First Received: September 30, 2010
Results First Received: March 1, 2017
Last Updated: May 18, 2017