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

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ClinicalTrials.gov Identifier: NCT01006135
Recruitment Status : Completed
First Posted : November 2, 2009
Results First Posted : July 9, 2012
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Pulmonary Disease, Chronic Obstructive

Detailed Description:

Study Design:

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


Study Design

Study Type : Observational
Actual Enrollment : 4852 participants
Time Perspective: Prospective
Official Title: Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region
Study Start Date : October 2009
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
COPD patients


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006135


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

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
First Posted: November 2, 2009    Key Record Dates
Results First Posted: July 9, 2012
Last Update Posted: April 10, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action