Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

Condition(s) targeted: COPD

Intervention: Tiotropium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: BI Austria GesmbH

The primary goal of this PMS study is to document the efficacy of Spiriva to improve physical activity measured by a score that is recommended in national COPD guidelines for monitoring the course of the disease.

Official title: Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

Study design: N/A

Primary outcome: Activities of daily living score after 21 to 28 days of treatment with Tiotropium

Secondary outcome: dyspnea score after 21 to 28 days of treatment with Tiotropium assessment of efficacy and tolerability on 4 point scale

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

INCLUSION CRITERIA:

- Patients with GP-suspected COPD

- 3 or more positive answers in GOLD Could it be COPD questionnaire

- Age over 40 years

EXCLUSION CRITERIA:

- Patient treated with Spiriva in the past year

- Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its

derivant, i. e. ipratropium, or any component of Spiriva

- Patient with known narrow-angle glaucoma

- Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction

- Patient with known moderate to severe renal impairment (i. e.,creatinine

clearance<=50ml/min)

- Pregnant or nursing women

- Patient with any significant disease other than COPD which would exclude him/her from

participating in the study

- Patients with any conditions listed in special precautions, drug interactions, and

contraindication of Spiriva's Austrian SPC

Boehringer Ingelheim, Admont, Austria

Boehringer Ingelheim, Afritz am See, Austria

Boehringer Ingelheim, Altenmarkt, Austria

Boehringer Ingelheim, Altm�nster, Austria

Boehringer Ingelheim, Bad Gleichenberg, Austria

Boehringer Ingelheim, Bad Goisern, Austria

Boehringer Ingelheim, Bad Hall, Austria

Boehringer Ingelheim, Bad H�ring, Austria

Boehringer Ingelheim, Bleiburg, Austria

Boehringer Ingelheim, Bludenz, Austria

Boehringer Ingelheim, Brixlegg, Austria

Boehringer Ingelheim, Drasenhofen, Austria

Boehringer Ingelheim, Enns, Austria

Boehringer Ingelheim, Fohnsdorf, Austria

Boehringer Ingelheim, G�nserndorf, Austria

Boehringer Ingelheim, Gmunden, Austria

Boehringer Ingelheim, Grafenstein, Austria

Boehringer Ingelheim, Graz, Austria

Boehringer Ingelheim, Gr�nbach, Austria

Boehringer Ingelheim, Gunskirchen, Austria

Boehringer Ingelheim, Gutenstein, Austria

Boehringer Ingelheim, Haid, Austria

Boehringer Ingelheim, Haid bei Ansfelden, Austria

Boehringer Ingelheim, Hainburg/a.d. Donau, Austria

Boehringer Ingelheim, Herzogenburg, Austria

Boehringer Ingelheim, H�rm, Austria

Boehringer Ingelheim, Innsbruck, Austria

Boehringer Ingelheim, Jenbach, Austria

Boehringer Ingelheim, Judenburg, Austria

Boehringer Ingelheim, Kindberg, Austria

Boehringer Ingelheim, Kirchberg Wechsel, Austria

Boehringer Ingelheim, Klagenfurt, Austria

Boehringer Ingelheim, Klein-P�chlarn, Austria

Boehringer Ingelheim, Knittelfeld, Austria

Boehringer Ingelheim, K�nigswiesen 132, Austria

Boehringer Ingelheim, Kuchl, Austria

Boehringer Ingelheim, Langenrohr, Austria

Boehringer Ingelheim, Lebring, Austria

Boehringer Ingelheim, Leobersdorf, Austria

Boehringer Ingelheim, Linz, Austria

Boehringer Ingelheim, Lustenau, Austria

Boehringer Ingelheim, Mank, Austria

Boehringer Ingelheim, M�dling, Austria

Boehringer Ingelheim, Neuberg/M�rz, Austria

Boehringer Ingelheim, Neumarkt a.W., Austria

Boehringer Ingelheim, Neunkirchen, Austria

Boehringer Ingelheim, Niederhollabrunn, Austria

Boehringer Ingelheim, Obersch�tzen, Austria

Boehringer Ingelheim, Ollersdorf, Austria

Boehringer Ingelheim, Passail, Austria

Boehringer Ingelheim, Peesen, Austria

Boehringer Ingelheim, Pfarrkirchen, Austria

Boehringer Ingelheim, Pichl bei Wels, Austria

Boehringer Ingelheim, Pischeldorf, Austria

Boehringer Ingelheim, Rattenberg, Austria

Boehringer Ingelheim, Salzburg, Austria

Boehringer Ingelheim, Schwechat, Austria

Boehringer Ingelheim, St. Johann, Austria

Boehringer Ingelheim, St. Stefan o Stainz, Austria

Boehringer Ingelheim, St. Valentin, Austria

Boehringer Ingelheim, St. Veit Glan, Austria

Boehringer Ingelheim, St.Georgen/Judenburg 12, Austria

Boehringer Ingelheim, Stainach, Austria

Boehringer Ingelheim, Stasshof, Austria

Boehringer Ingelheim, Traismauer, Austria

Boehringer Ingelheim, Tulln, Austria

Boehringer Ingelheim, V�cklabruck, Austria

Boehringer Ingelheim, Wallern an der Trattnach, Austria

Boehringer Ingelheim, Wei�trach, Austria

Boehringer Ingelheim, Weiz, Austria

Boehringer Ingelheim, Wien, Austria

Boehringer Ingelheim, Wilhelmsburg, Austria

Boehringer Ingelheim, Wolfsberg, Austria

Boehringer Ingelheim, Wolkersdorf, Austria

Ending date: June 2008
Last updated: June 12, 2008