Premature discontinuation of patients: A potential bias in COPD clinical trials

European Respiratory Journal

Volumn 30, Issue 5, 2007, Pages 898-906

  Kesten, S ^a   Plautz, M ^b   Piquette, C A ^c   Habib, M P ^d   Niewoehner, D E ^e  

^a BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^b UNIVERSITY OF KANSAS MEDICAL CENTER   (United States)

^c UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^d UNIVERSITY OF ARIZONA   (United States)

^e UNIVERSITY OF MINNESOTA   (United States)

Author keywords

Adverse events; Bronchodilators; Chronic obstructive pulmonary disease; Clinical trials; Discontinuation; Tiotropium

Indexed keywords

BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; IPRATROPIUM BROMIDE; LEUKOTRIENE RECEPTOR BLOCKING AGENT; PLACEBO; THEOPHYLLINE; TIOTROPIUM BROMIDE;

ADULT; AGED; ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FORCED EXPIRATORY VOLUME; HEART DISEASE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

AGED; BRONCHODILATOR AGENTS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; PATIENT DROPOUTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; RESEARCH DESIGN; RETROSPECTIVE STUDIES; SCOPOLAMINE DERIVATIVES; SPIROMETRY;

EID: 38849186086     PISSN: 09031936     EISSN: None     Source Type: Journal    
DOI: 10.1183/09031936.00104606     Document Type: Article

References (19)

1. Tolmie EP, Mungall MMB, Louden G, Lindsay GM, Gaw A. Understanding why older people participate in clinical trials: the experience of the Scottish PROPER participants. Age Ageing 2004; 33: 374-378.
2. Disse B, Speck GA, Rominger KL, Witek TJ Jr, Hammer R. Tiotropium (Spiriva): mechanistical considerations and clinical profile in obstructive lung disease. Life Sci 1999; 64: 457-464.
3. Casaburi R, Mahler DA, Jones PW, et al. A long-term evaluation of once-daily tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002; 19: 217-224.
4. Vincken W, van Noord JA, Greefhorst AP, et al. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. Eur Respir J 2002; 19: 209-216.
5. Brusasco V, Hodder R, Miravitlles M, Korducki L, Towse L, Kesten S. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003; 58: 399-404.
6. O'Donnell D, Flüge T, Gerken F, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J 2004; 23: 832-840.
7. Maltais F, Hamilton A, Marciniuk D, et al. Improvements in symptom-limited exercise performance over 8 h with once-daily tiotropium in patients with COPD. Chest 2005; 128: 1168-1178.
8. Niewoehner DE, Rice K, Cote C, et al. Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Ann Intern Med 2005; 143: 317-326.
9. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease (COPD). Am J Respir Crit Care Med 1995; 152: S77-S120.
10. Morris JF, Koski A, Temple WP, Claremont A, Thomas DR. Fifteen-year interval spirometric evaluation of the Oregon predictive equations. Chest 1988; 93: 123-127.
11. Standardization of Spirometry, 1994 Update: American Thoracic Society. Am J Respir Crit Care Med 1995; 152: 1107-1136.
12. Medical Dictionary for Regulatory Activities (MedDRA). www.meddramsso.com.
13. Rothman KJ, Greenland S, eds. Modern Epidemiology. 2nd Edn. Philadelphia, Lippincott-Raven Publishers, 1998; pp. 29-46.
14. Seberová E, Andersson A. Oxis (formoterol given by Turbuhaler) showed as rapid an onset of action as salbutamol given by a pMDI. Respir Med 2000; 94: 607-611.
15. Cazzola M, Centanni S, Santus P, et al. The functional impact of adding salmeterol and tiotropium in patients with stable COPD. Respir Med 2004; 98: 1214-1221.
16. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. NHLBI/WHO workshop report. Bethesda, National Heart, Lung and Blood Institute, April 2001. Update 2005. www.goldcopd.com. Date last accessed: October 2006.
17. Burge PS, Calverley PM, Jones PW, et al. Randomised, double blind placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ 2000; 320: 1297-1303.
18. Calverley PM, Spencer S, Willits L, Burge PS, Jones PW, ISOLDE Study Group. Withdrawal from treatment as an outcome in the ISOLDE study of COPD. Chest 2003; 124: 1350-1356.
19. Waterhouse JC, Fishwick D, Burge PS, Calverley PMA, Anderson JA, on behalf of the ISOLDE Trial group. What caused death in the inhaled steroids in obstructive lung disease in Europe (ISOLDE) study? Eur Respir J 1999; 14: Suppl. 30, 387S.