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Clinical Trials/NCT01110564
NCT01110564
Completed
Not Applicable

A Cross-sectional Observational Study to Investigate Daily Symptom Variability, Effects of Symptom on Morning Activities and Therapeutic Expectations of Patients and Physicians in Chronic Obstructive Pulmonary Disease - SUNRISE Study

AstraZeneca1 site in 1 country515 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
AstraZeneca
Enrollment
515
Locations
1
Primary Endpoint
To evaluate daily symptom variability in Chronic Obstructive Pulmonary Disease (COPD) patients
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

The primary objective of this non-interventional study is to evaluate daily symptom variability in COPD patients. The secondary objectives are; to evaluate effects of COPD symptoms on the morning activities of patients, to determine therapeutic expectations of patients and physicians in COPD, to determine which and how frequent non-drug approaches are recommended in order to prevent COPD exacerbations, to define COPD patient profiles about the below-mentioned issues: Demographic characteristics, Disease characteristics, Concomitant diseases and implemented drug treatments. All patients, who apply to the study physicians and fulfill all patient selection criteria during patient enrolment period, will be included. Patients, who provide all of the following measures will be included in the study: To apply to a physician for outpatient treatment for any reason, Age over 45 years, being diagnosed with COPD, being a smoker or used to be a smoker once (> 10 package years), to give consent for the use of their medical data. The patients that exhibit the following exclusion criteria will be excluded from the study: COPD exacerbations still on-going or experienced in the last 3 months (Exacerbation is defined as worsening of COPD symptoms leading to antibiotic and/or short-term oral steroid treatment and/or hospitalization or admission to the emergency unit.); Presence of lung cancer or an important respiratory disease such as bronchiectasis, pulmonary fibrosis, interstitial pulmonary disease, tuberculosis, sarcoidosis; Participation in an interventional clinical trial at present and Enrollment in this study once. In this study, patients will be recorded at their visit to the physician and there will be no follow-up thereafter.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
December 2010
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • To apply to a physician for outpatient treatment for any reason; being diagnosed with COPD
  • being a smoker or used to be a smoker once (\> 10 package years)
  • to give consent for the use of their medical data

Exclusion Criteria

  • COPD exacerbations still on-going or experienced in the last 3 months
  • Presence of lung cancer or an important respiratory disease such as bronchiectasis, pulmonary fibrosis, interstitial pulmonary disease, tuberculosis, sarcoidosis
  • Participation in an interventional clinical trial at present and Enrollment in this study once

Outcomes

Primary Outcomes

To evaluate daily symptom variability in Chronic Obstructive Pulmonary Disease (COPD) patients

Time Frame: April - Dec 2010

Secondary Outcomes

  • To evaluate effects of COPD symptoms on the morning activities of patients; To determine therapeutic expectations of patients and physicians in COPD(April - Dec 2010)
  • To define COPD patient profiles about the below-mentioned issues: Demographic characteristics; Disease characteristics; Concomitant diseases; Implemented drug treatments(April - Dec 2010)
  • To determine which and how frequent non-drug approaches are recommended in order to prevent COPD exacerbations(April - Dec 2010)

Study Sites (1)

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