Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Study type: Observational

Funder types: Industry

Identifiers

NCT01006135

205.450

Details and patient eligibility

About

The objective of this observational study is to collect and evaluate data on Health Related Quality of Life (HRQoL) of Spiriva delivered by HandiHaler, using disease specific SGRQ in the national samples of Central & Central European patients with varying severities of chronic obstructive pulmonary disease (COPD) in the real life setting over the 6 months.

Full description

Study Design:

an open-label, uncontrolled and single arm post-marketing surveillance study

Enrollment: 4,852 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 40 years and older male and female ambulatory outpatients.
• Clinical diagnosis of Chronic Obstructive Lung Disease (COPD) (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines: Forced expiratory Volume in one second (FEV1)/ Forced Vital Capacity (FVC) < 0.7 and FEV1 < 80% predicted).
• Stable patient, without exacerbation for at least one month to the study.

Exclusion criteria

• Uncooperative patients as judged by the physician.
• Patients that have any condition which, according to the participating physician's opinion, might decrease the chance of obtaining satisfactory data to achieve the objectives of the observation study.
• Patients with any conditions excluded as per Country specific package insert.
• Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems.

Trial design

4,852 participants in 1 patient group

COPD patients