SOSPES: SPIRIVA® observational study measuring SGRQ score in routine medical practice in Central and Eastern Europe

Abstract

Purpose

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.

Conclusion

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.

Journal

Journal ID (nlm-ta): Int J Chron Obstruct Pulmon Dis

Journal ID (iso-abbrev): Int J Chron Obstruct Pulmon Dis

Journal ID (publisher-id): International Journal of COPD

Title: International Journal of Chronic Obstructive Pulmonary Disease

Publisher: Dove Medical Press

ISSN (Print): 1176-9106

ISSN (Electronic): 1178-2005

Publication date Collection: 2013

Publication date (Print): 2013

Publication date (Electronic): 09 October 2013

Volume: 8

Pages: 483-492

Affiliations

[1 ]University Clinic of Respiratory and Allergic Diseases Golnik, Golnik, Slovenia

[2 ]Military Institute of Medicine, Department of Immunology and Allergology, Warsaw, Poland

[3 ]Saint John Clinical Emergency Hospital, Bucharest, Romania

[4 ]Municipal Medical Institution City Hospital, Barnaul, Russian Federation

[5 ]SACCME, Slovak Medical University, Bratislava, Slovakia

[6 ]Clinical Hospital Center, Osijek, Croatia

[7 ]ADDS Sro, Jana Uhra, Brno, Czech Republic

[8 ]Boehringer Ingelheim RCV GmbH and Co KG, Ingelheim, Vienna, Austria

Author notes

Correspondence: Matjaž Fležar, Respiratory Function Laboratory, University Clinic of Respiratory and Allergic Diseases Golnik, SI – 4204 Golnik, Slovenia, Tel [phone], Fax [phone], Email matjaz.flezar@ 123456klinika-golnik.si

Article

Publisher ID: copd-8-483

DOI: 10.2147/COPD.S45640

PMC ID: 3806120

PubMed ID: 24159258

Copyright statement: © 2013 Fležar et al, publisher and licensee Dove Medical Press Ltd

License:

This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

Categories

Subject: Original Research