Review Article

Smoking and Idiopathic Pulmonary Fibrosis

Table 2

Ongoing clinical trials in pulmonary fibrosis.

Title: descriptionPhasePrimary outcomes measureTrial durationClinicalTrials.gov ID

Bosentan in PH in ILD Treatment Study: aims to determine the ability of bosentan to reduce PH in patients with scarring (fibrosing) lung disease4Fall in PVR of 20% over 16 wks4/30/2008 to 8/31/2010NCT00637065

Treprostinil Therapy for Pts with ILD and Severe PAH: the hypothesis is that IV or SC treprostinil can improve 6MWD, hemodynamics and QOL in pts with ILD and severe secondary PAH36MWD1/31/2008 to 2/28/2009NCT00705133

PAH Secondary to IPF and Treatment with Sildenafil: evaluates whether sildenafil improves morbidity and mortality in the peri-lung transplant setting in both IPF cohorts with either resting or exercise PAH46MWD2/28/2007 to 2/31/2009NCT00625079

Pilot Study of a Multi-Drug Regimen for Severe PF in HPS: evaluates if pravastatin, losartan, zileuton, N-acetylcysteine, and erythromycin used together can slow the course of PF in pts with HPS1/2Survival4/30/2007 to (date n/a)NCT00467831

A Study to Evaluate the Safety and Effectiveness of CNTO-888 Administered IV in Subjects with IPF: evaluates safety and efficacy of CNTO-8882Pulmonary function and safety12/31/2008 to 6/30/2012NCT00786201

Losartan in Treating Pts with IPF: evaluates the safety and efficacy of losartann/aFVC3/31/2009 to (date n/a)NCT00786201

Losartan in Treating PF Caused by Radiation Therapy in Pts with Stage I, II, or III NSCLC: evaluates the efficacy of losartan in this pt populationn/aChange in carbon monoxide diffusing capacity5/31/2009 to (date n/a)NCT00880386

Trial of Iloprost in PH Secondary to PF: evaluates safety and efficacy of iloprost3Safety; pulmonary arterial pressure; 6MWT3/31/2007 to 8/31/2007NCT00439543

Targeting Vascular Reactivity in IPF: evaluates if combination therapy with N-acetylcysteine, sildenafil, and losartan can improve function and exercise tolerance in pts with IPF2/3A 6MWT; QOL score9/30/2009 to 7/31/2013NCT00981747

Pomalidomide for Cough in Pts With IPF: evaluates the safety and efficacy of pomalidomide over a 12-week duration in the treatment of chronic cough in pts with IPF2Cough-related QOL7/31/2010 to 7/31/2013NCT01135199

Trial of IW-001 in Pts with IPF: an open-label, multicenter study designed to explore the biological and clinical effects of IW-0011Safety and tolerability9/30/2010 to 9/30/2011NCT01199887

A Study to Characterize the Safety, PK and Biological Activity of CC-930 in IPF: evaluates the safety and PK profile of CC-9302Safety and PK1/31/2011 to 1/30/2013NCT01203943

Safety and PK Study with AB-0024 in Pts with IPF: this dose-escalation study evaluates the safety, tolerability, PKs, and pharmacodynamics of AB-00241Safety and PK12/31/2010 to/31/2012NCT01242189

A Study of the Safety, Tolerability, PKs, and Pharmacodynamics of IV PRM-151 in Pts with IPF: this study includes multiple doses of IV PRM-1511bSafety and tolerability1/31/2011 to 8/31/2011NCT01254409

Safety, Tolerability, and Efficacy Study of IPF: evaluates the safety and tolerability of FG-3019 in pts with IPF and the efficacy of FG-3019 for attenuating fibrosis in these pts2aSafety and tolerability12/31/2010 to 12/31/2012NCT01262001

Safety and Efficacy of QAX-576 in Pts with Progressive IPF: designed to evaluate the safety, tolerability, PKs and efficacy of QAX-576 in pts with rapidly progressive IPF2Safety, tolerability, and effect on lung function12/31/2010 to (date n/a)NCT01266135

Combined PEX, Rituximab (a chimeric MAb against the protein CD20) and Steroids in Acute IPF Exacerbations: an open-label trial to compare combined plasma exchange, rituximab, and conventional corticosteroid administration on the outcomes of hospitalized pts1/2Feasibility and safety3/31/2011 to (date n/a)NCT01266317

Safety and Efficacy of BIBF-1120 at High-Dose in IPF Pts:. a prospective, randomized trial that compares BIBF-1120 with placebo3Annual rate of decline in FVC4/30/2011 to 1/31/2014NCT01335464

PH: pulmonary hypertension. ILD: interstitial lung disease. PVR: pulmonary vascular resistance. IPF: idiopathic pulmonary fibrosis. PAH: pulmonary arterial hypertension. 6MWD: six-minute walk distance. QOL: quality of life. PF: pulmonary fibrosis. n/a: not available. HPS: Hermansky-Pudlak syndrome. FVC: forced vital capacity. NSCLC: non-small cell lung cancer. 6MWT: 6-minute walk test. PK: pharmacokinetic. PEX: plasma exchange. MAb: monoclonal antibody.