title: SOSPES: SPIRIVA® observational study measuring SGRQ score in routine medical practice in Central and Eastern Europe.
abstract: OBJECTIVE
  The long-acting inhaled anticholinergic agent, tiotropium, is recommended as first-line maintenance therapy for moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) to improve symptoms, exercise tolerance, health status, and to reduce exacerbations. Few studies have evaluated the therapeutic efficacy of tiotropium in patients in routine clinical conditions. The current study was designed to investigate the therapeutic efficacy of tiotropium delivered via the HandiHaler® device on the health status of patients with COPD with Global initiative for chronic Obstructive Lung Disease (GOLD) disease classification 2-4 in six central and eastern European countries in a real-life clinical setting.
  
  
  METHODS
  The study was an open-label, prospective, uncontrolled, and single-arm surveillance study with three clinic visits during a 6-month observation period (baseline, and months 3 and 6). Health status was measured using the disease-specific St George's Respiratory Questionnaire (SGRQ). The primary efficacy endpoint was the mean change from baseline in SGRQ total score at the end of the 6-month observational period.
  
  
  RESULTS
  Patients treated with tiotropium 18 μg once daily showed statistically significant and clinically meaningful reduction (improvement) of 21.7 units in the SGRQ total score, regardless of smoking status or cardiac comorbidities at enrollment (P < 0.0001). The analysis also showed that age, treatment compliance, and GOLD disease classification were significant factors that impact the health status of patients with COPD differently.
  
  
  CONCLUSIONS
  These results provide further support for the use of the tiotropium HandiHaler® as first-line maintenance treatment of patients with COPD with a clinician-assessed disease.
authors.affiliation: University Clinic of Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.
authors.forename: Matjaž
authors.initials: M
authors.lastname: Fležar
authors.forename: Karina
authors.initials: K
authors.lastname: Jahnz-Różyk
authors.forename: Gloria
authors.initials: G
authors.lastname: Enache
authors.forename: Tatiana
authors.initials: T
authors.lastname: Martynenko
authors.forename: Peter
authors.initials: P
authors.lastname: Kristufek
authors.forename: Sanda
authors.initials: S
authors.lastname: Škrinjarić-Cincar
authors.forename: Pavla
authors.initials: P
authors.lastname: Kadlecová
authors.forename: Goran
authors.initials: G
authors.lastname: Martinovic
mesh_terms: D000280:Administration, Inhalation; D000367:Age Factors; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018680:Cholinergic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005061:Europe, Eastern; D005260:Female; D006304:Health Status; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D015999:Multivariate Analysis; D009330:Nebulizers and Vaporizers; D011237:Predictive Value of Tests; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis* / Q000188:drug therapy* / Q000503:physiopathology; D020127:Recovery of Function; D012307:Risk Factors; D012602:Scopolamine Derivatives / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D000069447:Tiotropium Bromide; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D018680:Cholinergic Antagonists; D012602:Scopolamine Derivatives; D000069447:Tiotropium Bromide
keywords: HandiHaler®; chronic obstructive pulmonary disease; health-related quality of life; tiotropium