The Tiotropium Safety and Performance in Respimat® (TIOSPIR®) Trial: Spirometry Outcomes

Respiratory Research

Volumn 16, Issue 1, 2015, Pages

  Anzueto, Antonio ^a   Wise, Robert ^b   Calverley, Peter ^c   Dusser, Daniel ^d   Tang, Wenbo ^e   Metzdorf, Norbert ^f   Dahl, Ronald ^g  

^a VETERANS AFFAIRS MEDICAL CENTER   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF LIVERPOOL   (United Kingdom)

^d Institut Cochin   (France)

^e BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

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

^g ODENSE UNIVERSITY HOSPITAL   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLINERGIC RECEPTOR BLOCKING AGENT; TIOTROPIUM BROMIDE; BRONCHODILATING AGENT;

ADULT; ARTICLE; BODY MASS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; DISEASE CLASSIFICATION; DOUBLE BLIND PROCEDURE; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; FEMALE; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HUMAN; LUNG FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; RANDOMIZED CONTROLLED TRIAL; SPIROMETRY; TREATMENT DURATION; TREATMENT RESPONSE; AGED; COMPARATIVE STUDY; DRUG ADMINISTRATION; DRUG EFFECTS; INHALATIONAL DRUG ADMINISTRATION; LUNG; MIDDLE AGED; NEBULIZER; PATHOPHYSIOLOGY; PREDICTIVE VALUE; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SEVERITY OF ILLNESS INDEX; TIME FACTOR; TREATMENT OUTCOME; VITAL CAPACITY;

ADMINISTRATION, INHALATION; AGED; BRONCHODILATOR AGENTS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; LUNG; MALE; MIDDLE AGED; NEBULIZERS AND VAPORIZERS; PREDICTIVE VALUE OF TESTS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; SEVERITY OF ILLNESS INDEX; SPIROMETRY; TIME FACTORS; TIOTROPIUM BROMIDE; TREATMENT OUTCOME; VITAL CAPACITY;

EID: 84941565154     PISSN: 14659921     EISSN: 1465993X     Source Type: Journal    
DOI: 10.1186/s12931-015-0269-4     Document Type: Article

References (21)

1. Bateman E, Singh D, Smith D, Disse B, Towse L, Massey D, et al. Efficacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies. Int J Chron Obstruct Pulmon Dis. 2010;5:197-208.
2. Bateman ED, Tashkin D, Siafakas N, Dahl R, Towse L, Massey D, et al. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med. 2010;104:1460-72.
3. Casaburi R, Mahler DA, Jones PW, Wanner A, San PG, ZuWallack RL, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002;19:217-24.
4. Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359:1543-54.
5. Summary of Product Characteristics: Spiriva Respimat. 2013.
6. Wise RA, Anzueto A, Calverley P, Dahl R, Dusser D, Pledger G, et al. The Tiotropium Safety and Performance in Respimat Trial (TIOSPIR), a large scale, randomized, controlled, parallel-group trial-design and rationale. Respir Res. 2013;14:40.
7. Wise RA, Anzueto A, Cotton D, Dahl R, Devins T, Disse B, et al. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med. 2013;369:1491-501.
8. Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993;16:5-40.
9. Mallinckrod CH, Lane PW, Schnell D, Peng Y, Mancuso JP. Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials. Drug Information Journal. 2008;42:303-19.
10. Hvizdos KM, Goa KL. Tiotropium bromide. Drugs. 2002;62:1195-203.
11. Summary of Product Characteristics (SPC): Spiriva 18 microgram inhalation powder, hard capsule [ http://www.medicines.org.uk/emc/medicine/10039/SPC/ ]
12. Summary of Product Characteristics (SPC): Spiriva Respimat 2.5 microgram inhalation solution [ http://www.medicines.org.uk/emc/medicine/20134/SPC ]
13. Celli BR, Thomas NE, Anderson JA, Ferguson GT, Jenkins CR, Jones PW, et al. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am J Respir Crit Care Med. 2008;178:332-8.
14. Vestbo J, Edwards LD, Scanlon PD, Yates JC, Agusti A, Bakke P, et al. Changes in forced expiratory volume in 1second over time in COPD. N Engl J Med. 2011;365:1184-92.
15. Fletcher C, Peto R. The natural history of chronic airflow obstruction. Br Med J. 1977;1:1645-8.
16. Tantucci C, Modina D. Lung function decline in COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:95-9.
17. Decramer M, Cooper CB. Treatment of COPD: the sooner the better? Thorax. 2010;65:837-41.
18. Anzueto A, Tashkin D, Menjoge S, Kesten S. One-year analysis of longitudinal changes in spirometry in patients with COPD receiving tiotropium. Pulm Pharmacol Ther. 2005;18:75-81.
19. Celli B, Decramer M, Kesten S, Liu D, Mehra S, Tashkin DP. Mortality in the 4-year trial of tiotropium (UPLIFT) in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009;180:948-55.
20. Celli B, Decramer M, Leimer I, Vogel U, Kesten S, Tashkin DP. Cardiovascular safety of tiotropium in patients with COPD. Chest. 2010;137:20-30.
21. Anzueto A, Wise R, Pledger G, Calverley P, Dusser D, Cotton D, et al. The tiotropium safety and performance in respimat (tiospir) trial: Bronchodilator efficacy in a spirometry substudy. Chest. 2013;144:1027A.