Clinical trial NCT01214187: Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis
Official title: Phase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: idiopathic pulmonary fibrosis
IPF
pulmonary fibrosis
carbon monoxide
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of California, San Francisco
name: University of Chicago
name: University of Illinois at Chicago
name: University of Michigan
name: Columbia University
name: Tulane University
name: University of Washington
First posted: 2010-10-04
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by destruction of normal epithelial structure, proliferation of fibroblasts, and deposition of connective-tissue matrix proteins. There are currently no effective therapies for IPF. Over the past two decades, preclinical studies of inhaled low dose carbon monoxide (CO) have shown that this biologically active diatomic gas possesses properties that would make it a viable novel therapy for IPF. CO therapy has been well tolerated in Phase I and Phase II human trials to date. This phase II study is designed to investigate whether IPF patients show evidence of decreased peripheral blood levels of matrix metalloproteinase-7 (MMP7) and stability of secondary indicators of disease progression after 3 months of inhaled therapy.

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

Primary outcomes:
measure: Serum MMP7 Level
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Total Lung Capacity % Predicted Values (TLC)
timeFrame: Baseline to Week 12
measure: Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values
timeFrame: Baseline to Week 12
measure: Six Minute Walk Distance
timeFrame: Baseline to Week 12
measure: St George's Respiratory Questionnaire
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Columbia University
state: New York
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Brigham and Women's Hospital
name: Rosas O Ivan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Joe GN Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosas IO, Goldberg HJ, Collard HR, El-Chemaly S, Flaherty K, Hunninghake GM, Lasky JA, Lederer DJ, Machado R, Martinez FJ, Maurer R, Teller D, Noth I, Peters E, Raghu G, Garcia JGN, Choi AMK. A Phase II Clinical Trial of Low-Dose Inhaled Carbon Monoxide in Idiopathic Pulmonary Fibrosis. Chest. 2018 Jan;153(1):94-104. doi: 10.1016/j.chest.2017.09.052. Epub 2017 Oct 31.