Efficacy endpoints for idiopathic pulmonary fibrosis trials

The Lancet Respiratory Medicine

Volumn 3, Issue 5, 2015, Pages 335-337

  Richeldi, Luca ^a  

^a UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

NINTEDANIB; PIRFENIDONE;

CLINICAL TRIAL (TOPIC); DISEASE COURSE; DISEASE EXACERBATION; DRUG APPROVAL; DRUG EFFICACY; FIBROSING ALVEOLITIS; FORCED VITAL CAPACITY; HEALTH CARE ORGANIZATION; HEALTH CARE SYSTEM; HOSPITAL ADMISSION; HUMAN; LUNG FUNCTION; MORTALITY; NOTE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SURVIVAL RATE; FEMALE; HOSPITALIZATION; MALE; PATHOPHYSIOLOGY; PHYSIOLOGY; STATISTICS AND NUMERICAL DATA; VITAL CAPACITY;

FEMALE; HOSPITALIZATION; HUMANS; IDIOPATHIC PULMONARY FIBROSIS; MALE; VITAL CAPACITY;

EID: 84929032257     PISSN: 22132600     EISSN: 22132619     Source Type: Journal    
DOI: 10.1016/S2213-2600(15)00146-0     Document Type: Note

References (10)

1. Vancheri C, Failla M, Crimi N, Raghu G Idiopathic pulmonary fibrosis: a disease with similarities and links to cancer biology. Eur Respir J 2010, 35:496-504.
2. Raghu G, Collard HR, Anstrom KJ, et al. Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials. Am J Respir Crit Care Med 2012, 185:1044-1048.
3. Bois du RM, Nathan SD, Richeldi L, Schwarz MI, Noble PW Idiopathic pulmonary fibrosis: lung function is a clinically meaningful endpoint for phase III trials. Am J Respir Crit Care Med 2012, 186:712-715.
4. Wells AU, Behr J, Costabel U, et al. Hot off the breath: mortality as a primary end-point in IPF treatment trials-the best is the enemy of the good. Thorax 2012, 67:938-940. for the European IPF consensus group.
5. King TE, Albera C, Bradford WZ, et al. All-cause mortality rate in patients with idiopathic pulmonary fibrosis: implications for the design and execution of clinical trials. Am J Respir Crit Care Med 2014, 189:825-831.
6. Karimi-Shah BA, Chowdhury BA Forced vital capacity in idiopathic pulmonary fibrosis: FDA review of pirfenidone and nintedanib. N Engl J Med 2015, 372:1189-1191.
7. Ryerson CJ, Collard HR Hot off the breath: a big step forward for idiopathic pulmonary fibrosis. Thorax 2014, 69:791-792.
8. Durheim MT, Collard HR, Roberts RS, et al. Association of hospital admission and forced vital capacity endpoints with survival in patients with idiopathic pulmonary fibrosis: analysis of a pooled cohort from three clinical trials. Lancet Respir Med 2015, for the IPFnet investigators, published online April 16. http://dx.doi.org/S2213-2600(15)00093-4.
9. Ryerson CJ, Vittinghoff E, Ley B, et al. Predicting survival across chronic interstitial lung disease: the ILD-GAP model. Chest 2014, 145:723-728.
10. Collard HR, Yow E, Richeldi L, Anstrom KJ, Glazer C Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. Respir Res 2013, 14:73. for the IPFnet investigators.