Skip to main content
OpenTrials
Completed

NCT Number: NCT01006135

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 1, Drniš, Croatia

Loading trial locations.

About this study

Study Design:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline

    Time frame: Baseline and 6 months

    The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)

Secondary outcomes

  1. Additional Bronchodilator or Inhaled Corticosteroids (ICS)

    Time frame: 6 months

    Pulmonary medication from baseline to visit 3 (6 months)

  2. Compliance of Patients

    Time frame: 6 months

    Patients are considered to be compliant if the difference of the number of days between visit 1 (baseline) and visit 3 (6months) and the number of actual taken capsules is less than 10.

  3. Patients With Any Adverse Events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 2, 2009
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.