• We are sorry, but NCBI web applications do not support your browser and may not function properly. More information
Logo of thoraxThoraxInstructions for authorsInstructions for authors
Thorax. May 2003; 58(5): 399–404.
PMCID: PMC1746668

Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD

Abstract

Background: A study was undertaken to record exacerbations and health resource use in patients with COPD during 6 months of treatment with tiotropium, salmeterol, or matching placebos.

Methods: Patients with COPD were enrolled in two 6-month randomised, placebo controlled, double blind, double dummy studies of tiotropium 18 µg once daily via HandiHaler or salmeterol 50 µg twice daily via a metered dose inhaler. The two trials were combined for analysis of heath outcomes consisting of exacerbations, health resource use, dyspnoea (assessed by the transitional dyspnoea index, TDI), health related quality of life (assessed by St George's Respiratory Questionnaire, SGRQ), and spirometry.

Results: 1207 patients participated in the study (tiotropium 402, salmeterol 405, placebo 400). Compared with placebo, tiotropium but not salmeterol was associated with a significant delay in the time to onset of the first exacerbation. Fewer COPD exacerbations/patient year occurred in the tiotropium group (1.07) than in the placebo group (1.49, p<0.05); the salmeterol group (1.23 events/year) did not differ from placebo. The tiotropium group had 0.10 hospital admissions per patient year for COPD exacerbations compared with 0.17 for salmeterol and 0.15 for placebo (not statistically different). For all causes (respiratory and non-respiratory) tiotropium, but not salmeterol, was associated with fewer hospital admissions while both groups had fewer days in hospital than the placebo group. The number of days during which patients were unable to perform their usual daily activities was lowest in the tiotropium group (tiotropium 8.3 (0.8), salmeterol 11.1 (0.8), placebo 10.9 (0.8), p<0.05). SGRQ total score improved by 4.2 (0.7), 2.8 (0.7) and 1.5 (0.7) units during the 6 month trial for the tiotropium, salmeterol and placebo groups, respectively (p<0.01 tiotropium v placebo). Compared with placebo, TDI focal score improved in both the tiotropium group (1.1 (0.3) units, p<0.001) and the salmeterol group (0.7 (0.3) units, p<0.05). Evaluation of morning pre-dose FEV1, peak FEV1 and mean FEV1 (0–3 hours) showed that tiotropium was superior to salmeterol while both active drugs were more effective than placebo.

Conclusions: Exacerbations of COPD and health resource usage were positively affected by daily treatment with tiotropium. With the exception of the number of hospital days associated with all causes, salmeterol twice daily resulted in no significant changes compared with placebo. Tiotropium also improved health related quality of life, dyspnoea, and lung function in patients with COPD.

Full Text

The Full Text of this article is available as a PDF (188K).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Friedman M, Hilleman DE. Economic burden of chronic obstructive pulmonary disease. Impact of new treatment options. Pharmacoeconomics. 2001;19(3):245–254. [PubMed]
  • Belman MJ, Botnick WC, Shin JW. Inhaled bronchodilators reduce dynamic hyperinflation during exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1996 Mar;153(3):967–975. [PubMed]
  • Anthonisen NR, Manfreda J, Warren CP, Hershfield ES, Harding GK, Nelson NA. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987 Feb;106(2):196–204. [PubMed]
  • Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA, Maslen TK. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ. 2000 May 13;320(7245):1297–1303. [PMC free article] [PubMed]
  • Destache CJ, Dewan N, O'Donohue WJ, Campbell JC, Angelillo VA. Clinical and economic considerations in the treatment of acute exacerbations of chronic bronchitis. J Antimicrob Chemother. 1999 Mar;43 (Suppl A):107–113. [PubMed]
  • Friedman M, Serby CW, Menjoge SS, Wilson JD, Hilleman DE, Witek TJ., Jr Pharmacoeconomic evaluation of a combination of ipratropium plus albuterol compared with ipratropium alone and albuterol alone in COPD. Chest. 1999 Mar;115(3):635–641. [PubMed]
  • Mahler DA, Donohue JF, Barbee RA, Goldman MD, Gross NJ, Wisniewski ME, Yancey SW, Zakes BA, Rickard KA, Anderson WH. Efficacy of salmeterol xinafoate in the treatment of COPD. Chest. 1999 Apr;115(4):957–965. [PubMed]
  • Rennard SI, Anderson W, ZuWallack R, Broughton J, Bailey W, Friedman M, Wisniewski M, Rickard K. Use of a long-acting inhaled beta2-adrenergic agonist, salmeterol xinafoate, in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Apr;163(5):1087–1092. [PubMed]
  • Koyama H, Nishimura K, Ikeda A, Izumi T. A comparison of the bronchodilating effects of oxitropium bromide and fenoterol in patients with chronic obstructive pulmonary disease. Chest. 1993 Dec;104(6):1743–1747. [PubMed]
  • Barnes PJ, Belvisi MG, Mak JC, Haddad EB, O'Connor B. Tiotropium bromide (Ba 679 BR), a novel long-acting muscarinic antagonist for the treatment of obstructive airways disease. Life Sci. 1995;56(11-12):853–859. [PubMed]
  • 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(6-7):457–464. [PubMed]
  • Casaburi R, Mahler DA, Jones PW, Wanner A, San Pedro G, ZuWallack RL, Menjoge SS, Serby CW, Witek T., Jr A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J. 2002 Feb;19(2):217–224. [PubMed]
  • Vincken W, van Noord JA, Greefhorst APM, Bantje Th A, Kesten S, Korducki L, Cornelissen PJG. Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium. Eur Respir J. 2002 Feb;19(2):209–216. [PubMed]
  • Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984 Jun;85(6):751–758. [PubMed]
  • Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321–1327. [PubMed]
  • Jones PW, Bosh TK. Quality of life changes in COPD patients treated with salmeterol. Am J Respir Crit Care Med. 1997 Apr;155(4):1283–1289. [PubMed]
  • Rutten-van Mölken M, Roos B, Van Noord JA. An empirical comparison of the St George's Respiratory Questionnaire (SGRQ) and the Chronic Respiratory Disease Questionnaire (CRQ) in a clinical trial setting. Thorax. 1999 Nov;54(11):995–1003. [PMC free article] [PubMed]
  • O'Donnell DE. Breathlessness in patients with chronic airflow limitation. Mechanisms and management. Chest. 1994 Sep;106(3):904–912. [PubMed]
  • O'Donnell DE, Lam M, Webb KA. Spirometric correlates of improvement in exercise performance after anticholinergic therapy in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Aug;160(2):542–549. [PubMed]
  • Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 May;157(5 Pt 1):1418–1422. [PubMed]

Articles from Thorax are provided here courtesy of BMJ Group

Formats:

Related citations in PubMed

See reviews...See all...

Cited by other articles in PMC

See all...

Links

  • Cited in Books
    Cited in Books
    PubMed Central articles cited in books
  • Compound
    Compound
    PubChem Compound links
  • MedGen
    MedGen
    Related information in MedGen
  • PubMed
    PubMed
    PubMed citations for these articles
  • Substance
    Substance
    PubChem Substance links

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...