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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01006135
First received: October 30, 2009
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition
Pulmonary Disease, Chronic Obstructive

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)


Secondary Outcome Measures:
  • Additional Bronchodilator or Inhaled Corticosteroids (ICS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pulmonary medication from baseline to visit 3 (6 months)

  • Compliance of Patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Patients With Any Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 4852
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD patients

Detailed Description:

Study Design:

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006135

  Show 864 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01006135     History of Changes
Other Study ID Numbers: 205.450
Study First Received: October 30, 2009
Results First Received: June 2, 2012
Last Updated: March 12, 2014
Health Authority: Croatia: Agency for Medicinal Product and Medical Devices
Poland: Registration Medicinal Product Medical Device Biocidal Product
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on August 27, 2014