title: Early impact of treatment with tiotropium, long-acting anticholinergic preparation, in patients with COPD - real-life experience from an observational study.
abstract: BACKGROUND
  Long-acting inhaled bronchodilators, including anticholinergic tiotropium, are recommended for the maintenance therapy of chronic obstructive pulmonary disease (COPD). It has been shown in a number of studies that treatment with tiotropium alleviates symptoms, improves exercise tolerance, health status, and reduces exacerbations in patients with moderate to very severe stage COPD.
  
  
  OBJECTIVE
  The aim of this noninterventional study was to observe the early effects of the maintenance treatment with tiotropium in patients with COPD of different severities, who had been previously treated on a regular basis, or as required, with at least one short-acting bronchodilator, in a real-life setting in Poland. The effect of the treatment was assessed through the collection of COPD Assessment Test (CAT) data.
  
  
  METHODS
  The MATHS clinical study was an observational, noninterventional, open-label, prospective, uncontrolled, single-arm, postmarketing, surveillance, real-life study conducted with the involvement of 236 pulmonology clinics based in Poland. The tiotropium observational period was 3 months. The health and COPD status was measured with the CAT questionnaire. The primary efficacy endpoint was the mean change from the baseline in the total CAT score at the end of the 3-month observational period.
  
  
  RESULTS
  Patients treated with 18 μg of tiotropium once daily for 3 months showed a statistically significant result, with a clinically meaningful mean reduction (improvement) of 7.0 points in the total CAT score. The improvement was slightly greater in patients with more severe COPD; the mean change in the total CAT score was 7.6 in the subgroup of patients with more severe COPD and 6.7 points in the subgroup of patients with moderate COPD.
  
  
  CONCLUSIONS
  Results of this real-life study provide further support for the use of tiotropium as a first-line maintenance treatment for patients with COPD of different severities in Poland.
authors.affiliation: Department of Immunology and Clinical Allergology, Military Institute of Medicine, Warsaw, Poland.
authors.forename: Karina
authors.initials: K
authors.lastname: Jahnz-Różyk
authors.affiliation: Boehringer Ingelheim Sp. z o.o., Warsaw, Poland.
authors.forename: Paweł
authors.initials: P
authors.lastname: Szepiel
mesh_terms: D000368:Aged; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018680:Cholinergic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006304:Health Status; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011044:Poland; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D020127:Recovery of Function; D012720:Severity of Illness Index; D013997:Time Factors; D000069447:Tiotropium Bromide / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D018680:Cholinergic Antagonists; D000069447:Tiotropium Bromide
keywords: CAT; GOLD classification; Spiriva® HandiHaler®; chronic obstructive pulmonary disease
references.citation: Chest. 2002 Jul;122(1):47-55
references.pmid: 12114338
references.citation: Cochrane Database Syst Rev. 2014;3:CD010844
references.pmid: 24671923
references.citation: Can Respir J. 2007 Jan-Feb;14(1):25-9
references.pmid: 17315055
references.citation: Thorax. 2008 May;63(5):402-7
references.pmid: 18234906
references.citation: Int J Chron Obstruct Pulmon Dis. 2008;3(2):301-10
references.pmid: 18686739
references.citation: N Engl J Med. 2008 Oct 9;359(15):1543-54
references.pmid: 18836213
references.citation: Eur Respir J. 2009 Sep;34(3):648-54
references.pmid: 19720809
references.citation: Lancet. 2009 Oct 3;374(9696):1171-8
references.pmid: 19716598
references.citation: Eur Respir J. 2010 Jul;36(1):65-73
references.pmid: 20185426
references.citation: N Engl J Med. 2011 Mar 24;364(12):1093-1103
references.pmid: 21428765
references.citation: Thorax. 2011 May;66(5):425-9
references.pmid: 21398686
references.citation: Pneumonol Alergol Pol. 2012;80(3):220-54
references.pmid: 22562274
references.citation: Int J Chron Obstruct Pulmon Dis. 2013;8:483-92
references.pmid: 24159258
references.citation: J Aerosol Med Pulm Drug Deliv. 2014 Feb;27(1):43-50
references.pmid: 23521168
references.citation: Lancet Respir Med. 2014 Mar;2(3):195-203
references.pmid: 24621681
references.citation: Thorax. 2003 May;58(5):399-404
references.pmid: 12728159