Review Article

Smoking and Idiopathic Pulmonary Fibrosis

Table 1

Closed clinical trials in pulmonary fibrosis.

Title: descriptionPhasePrimary outcomes measureTrial durationClinicalTrials.gov ID

Minocycline Therapy for Lung Scarring in Pts with IPF—A Pilot Study: evaluates the safety and efficacy of minocycline3Safety; efficacy9/13/2005 to (date n/a)NCT00203697

Interferon-Alpha Treatment of Chronic Cough in COPD and IPF: evaluates the effect lozenges containing interferon-alpha have on coughing2Frequency/severity of cough6/30/2008 to 3/31/2012NCT00690885

Efficacy and Safety of Oral Bosentan in Pts with IPF: this double-blind, multicenter trial investigated the possible use of bosentan in pts with IPF2/3Change in 6MWD8/31/2003 to 5/31/2010NCT00071461

Zileuton for the Treatment of IPF: an open-label trial of zileuton compared to azathioprine/prednisone for pts with IPF. Pts underwent a detailed assessment at baseline, followed by 3 mos of posttreatment monitoring for changes in symptoms and physiology2Change in LTB4 levels in bronchoalveolar lavage fluid1/31/2001 to (date n/a)NCT00262405

Open-Label, Extension Study in Patients with IPF Who Completed Protocol AC-052-321/BUILD 3: an open-label, extension study3Long-term safety and tolerability of bosentan3/31/2008 to 7/31/2010NCT00631475

Bosentan Use in ILD: BUILD 3 was a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled, event-driven, group sequential, superiority study3Time to occurrence of disease worsening or death up to end of study11/30/2006 to 7/31/2010NCT00391443

Pirfenidone for the Treatment of Pts with PF/IPF: assessed the long-term safety and efficacy of oral pirfenidone in doses of up to 40 mg/kg/day2AEs, clinical laboratory tests, directed physical exams8/31/2003 to 1/31/2011NCT00080223

Open-Label Study of the Long Term Safety of Pirfenidone in Pts with IPF: an open-label, multicenter, extension study for pts who completed the CAPACITY trials (PIPF-004 and PIPF-006)3Obtain safety data8/31/2008 to 7/31/2012NCT00662038

Macitentan Use in an IPF Clinical Study: the AC-055B201/MUSIC study compared one dose of macitentan versus placebo in pts with IPF2FVC changes5/31/2009 to 6/30/2011NCT00903331

Anticoagulant Effectiveness in IPF: tested the effectiveness of warfarin in pts with IPF3Time to death, nonbleeding/nonelective hospitalization, or >10% drop in FVC10/31/2009 to 12/31/2011NCT00957242

Roll Over Study from 1199.30 BIBF-1120 in IPF: this open-label, non-randomized uncontrolled design trial offers continuation of BIBF-1120 treatment for pts with IPF who have completed a prior clinical trial (1199.30) with that drug. Primary objective is to establish a long-term tolerability and safety profile. Secondary objectives are effects of long-term treatment on survival, safety, and efficacy2FVC decline (time frame: 3 years average)6/30/2010 to 6/30/2015NCT01170065

IPF: idiopathic pulmonary fibrosis. n/a: not available. COPD: chronic obstructive pulmonary disease. 6MWD: six-minute walking distance. LTB4: leukotriene B4. ILD: interstitial lung disease. BUILD: bosentan use in interstitial lung disease. PF: pulmonary fibrosis. AE: adverse event. MUSIC: macitentan use in an idiopathic pulmonary fibrosis clinical study. FVC: forced vital capacity.