Study to Investigate Daily Symptom Variability, Symptom Effects on Morning Activities of Chronic Obstructive Disease
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
1 other identifier
observational
515
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2010
Shorter than P25 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 23, 2010
CompletedFirst Posted
Study publicly available on registry
April 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 28, 2011
January 1, 2011
8 months
April 23, 2010
January 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate daily symptom variability in Chronic Obstructive Pulmonary Disease (COPD) patients
April - Dec 2010
Secondary Outcomes (3)
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 Arms (1)
1
COPD patients
Eligibility Criteria
Chronic Obstructive Pulmonary Disease (COPD)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (19)
Research Site
Aksaray, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Antalya, Turkey (Türkiye)
Research Site
Aydin, Turkey (Türkiye)
Research Site
Bilecik, Turkey (Türkiye)
Research Site
Bolu, Turkey (Türkiye)
Research Site
Bursa, Turkey (Türkiye)
Research Site
Denizli, Turkey (Türkiye)
Research Site
Elâzığ, Turkey (Türkiye)
Research Site
Hatay, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Izmir, Turkey (Türkiye)
Research Site
Kocaeli, Turkey (Türkiye)
Research Site
Konya, Turkey (Türkiye)
Research Site
Manisa, Turkey (Türkiye)
Research Site
Rize, Turkey (Türkiye)
Research Site
Samsun, Turkey (Türkiye)
Research Site
Sanliurfa, Turkey (Türkiye)
Research Site
Yozgat, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tulin Kuyucu
Sureyyapasa Chest Disease Hospital
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 23, 2010
First Posted
April 26, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 28, 2011
Record last verified: 2011-01