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

Boehringer Ingelheim754 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

754

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

TiotropiumDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (73)

Outcomes

Primary Outcomes

Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva

The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)

Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

Secondary Outcomes

Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva

The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)

Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

Global Assessment of Efficacy by Patient

Rating scale ranging from very good (best value) to not satisfactory (worst value)

Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

Global Assessment of Tolerability by Patient

Rating scale ranging from very good (best value) to not satisfactory (worst value)

Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

Global Assessment of Efficacy by Physician

Rating scale ranging from very good (best value) to not satisfactory (worst value)

Time frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)

Global Assessment of Tolerability by Physician

Rating scale ranging from very good (best value) to not satisfactory (worst value)

Data from ClinicalTrials.gov

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