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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01214187 |
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Date of registration:
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30/09/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis
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Scientific title:
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Phase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary Fibrosis |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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58 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01214187 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Rosas O Ivan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brigham and Women's Hospital |
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Name:
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Joe GN Garcia, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Illinois at Chicago |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults above the age of 18 and equal to or below the age of 85
- Diagnosis of IPF by biopsy or
- American Thoracic Society (ATS)/European Respiratory Society (ERS)/ Latin American
Thoracic Association (ALAT) Guidelines (Am J Respir Crit Care Med Vol 183. pp
788-824,2011)
- Forced vital capacity (FVC) greater than or equal to 50% predicted, greater than or
equal to one month off all medications prescribed for IPF
Exclusion Criteria:
- Evidence of active infection within the last month
- Significant obstructive respiratory defect
- Supplemental oxygen required to maintain an oxygen saturation over 88% at rest
- History of myocardial infarction within the last year, heart failure within the last 3
years or cardiac arrhythmia requiring drug therapy
- History of smoking within 4 weeks of screening
- Pregnancy or lactation
- Participation in another therapeutic clinical trial
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: inhaled carbon monoxide
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Other: Oxygen
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Primary Outcome(s)
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Serum MMP7 Level
[Time Frame: Baseline to Week 12]
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Secondary Outcome(s)
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Six Minute Walk Distance
[Time Frame: Baseline to Week 12]
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Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values
[Time Frame: Baseline to Week 12]
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Total Lung Capacity % Predicted Values (TLC)
[Time Frame: Baseline to Week 12]
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St George's Respiratory Questionnaire
[Time Frame: Baseline to Week 12]
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Secondary ID(s)
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1U01HL105371
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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