Clinical trial NCT00615992: Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines
Official title: Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 754
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: primary care

Brief summary: The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected chronic obstructive pulmonary disease (COPD)
* 3 or more positive answers in COPD questionnaire
* Age over 40 years

Exclusion Criteria:

* Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics
* 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 in Austrian summary of product characteristics

Primary outcomes:
measure: Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva
timeFrame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Secondary outcomes:
measure: Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva
timeFrame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
measure: Global Assessment of Efficacy by Patient
timeFrame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
measure: Global Assessment of Tolerability by Patient
timeFrame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
measure: Global Assessment of Efficacy by Physician
timeFrame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
measure: Global Assessment of Tolerability by Physician
timeFrame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
Other outcomes:
Locations:
city: Admont
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Afritz am See
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Altenmarkt
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Altmünster
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bad Gleichenberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bad Goisern
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bad Hall
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bad Häring
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bleiburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bludenz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Brixlegg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Drasenhofen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Enns
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Fohnsdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gmunden
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Grafenstein
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Graz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Grünbach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gunskirchen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gutenstein
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gänserndorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Haid bei Ansfelden
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Haid
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Hainburg/a.d. Donau
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Herzogenburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Hürm
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Innsbruck
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Jenbach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Judenburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Kindberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Kirchberg Wechsel
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Klagenfurt
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Klein-Pöchlarn
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Knittelfeld
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Kuchl
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Königswiesen 132
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Langenrohr
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Lebring
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Leobersdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Linz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Lustenau
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Mank
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Mödling
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Neuberg/Mürz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Neumarkt a.W.
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Neunkirchen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Niederhollabrunn
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Oberschützen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Ollersdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Passail
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Peesen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Pfarrkirchen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Pichl bei Wels
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Pischeldorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Rattenberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Salzburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Schwechat
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Johann
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Stefan o Stainz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Valentin
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Veit Glan
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St.Georgen/Judenburg 12
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Stainach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Stasshof
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Traismauer
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Tulln
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Vöcklabruck
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wallern an der Trattnach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Weiz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Weißtrach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wilhelmsburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wolfsberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wolkersdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: