Phase 2
N=58
Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01214187 ↗Enrolled (actual)
58
Serious AEs
17.2%
Results posted
Jun 2017
Primary outcome: Primary: Serum MMP7 Level — -0.15; 0.88 ng/ml — p=0.2072
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- inhaled carbon monoxide (Drug); Oxygen (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum MMP7 Level |
-0.15; 0.88 | 0.2072 |
| SECONDARY Total Lung Capacity % Predicted Values (TLC) |
-2.29; -1.44 | 0.5882 |
| SECONDARY Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values |
1.10; 0.46 | 0.7401 |
| SECONDARY Six Minute Walk Distance |
-35.54; 12.92 | 0.0099 sig |
| SECONDARY St George's Respiratory Questionnaire |
-2.12; -1.55 | 0.8124 |
Summary
The purpose of this study is to determine whether low concentration inhaled carbon monoxide is effective in treating idiopathic pulmonary fibrosis.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01214187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.