Phase 2 Completed N=58 Randomized Double-blind Treatment

Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT01214187 ↗

Enrolled (actual)

Serious AEs

17.2%

Results posted

Jun 2017

Primary outcomePrimary: Serum MMP7 Level — -0.15; 0.88 ng/ml — p=0.2072

Summary

The purpose of this study is to determine whether low concentration inhaled carbon monoxide is effective in treating idiopathic pulmonary fibrosis.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.