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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00615992

Enrollment

754

Registered

2008-02-14

Start date

2007-04-30

Completion date

Unknown

Last updated

2016-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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.

Interventions

DRUGTiotropium

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)

Secondary

Measure	Time frame	Description
Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
Global Assessment of Efficacy by Patient	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	Rating scale ranging from very good (best value) to not satisfactory (worst value)
Global Assessment of Tolerability by Patient	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	Rating scale ranging from very good (best value) to not satisfactory (worst value)
Global Assessment of Efficacy by Physician	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	Rating scale ranging from very good (best value) to not satisfactory (worst value)
Global Assessment of Tolerability by Physician	Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)	Rating scale ranging from very good (best value) to not satisfactory (worst value)

Countries

Austria

Participant flow

Participants by arm

Arm	Count
Spiriva® (Tiotropium Bromide) Tiotropium bromide 18μg inhalation capsules once-daily	687
Total	687

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Protocol Violation	67

Baseline characteristics

Characteristic	Spiriva® (Tiotropium Bromide)
Age, Continuous	63.0 years STANDARD_DEVIATION 12.5
Sex/Gender, Customized Female	269 participants
Sex/Gender, Customized Male	414 participants
Sex/Gender, Customized Missing	4 participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 754
serious Total, serious adverse events	0 / 754

Outcome results

Primary

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)