Overview

This trial is active, not recruiting.

Condition idiopathic pulmonary fibrosis
Treatments inhaled carbon monoxide, oxygen
Phase phase 2
Sponsor Brigham and Women's Hospital
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date July 2011
End date October 2014
Trial size 58 participants
Trial identifier NCT01214187, 1U01HL105371

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Experimental)
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 CO
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.
(Placebo Comparator)
oxygen O2
Room air oxygen concentrations will be administered as placebo

Primary Outcomes

Measure
Serum MMP7 level
time frame: 3 months

Secondary Outcomes

Measure
Total lung capacity (TLC)
time frame: 3 months
Diffusing capacity for carbon monoxide
time frame: 3 months
Six minute walk distance
time frame: 3 months
St George's Respiratory Questionnaire
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - Adults above the age of 18 and equal to or below the age of 85 - Diagnosis of IPF by biopsy or - ATS/ERS/ALAT Guidelines (Am J Respir Crit Care Med Vol 183. pp 788-824,2011) - 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

Additional Information

Official title Phase II Study of Inhaled CO for the Treatment of Idiopathic Pulmonary Fibrosis
Principal investigator Rosas O Ivan, MD
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 MMP7 and stability of secondary indicators of disease progression after 3 months of inhaled therapy.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.