Study to Investigate Daily Symptom Variability, Symptom Effects on Morning Activities of Chronic Obstructive Disease
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Purpose
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.
| Condition |
|---|
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Chronic Obstructive Pulmonary Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | 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 |
- To evaluate daily symptom variability in Chronic Obstructive Pulmonary Disease (COPD) patients [ Time Frame: April - Dec 2010 ] [ Designated as safety issue: No ]
- To evaluate effects of COPD symptoms on the morning activities of patients; To determine therapeutic expectations of patients and physicians in COPD [ Time Frame: April - Dec 2010 ] [ Designated as safety issue: No ]
- To define COPD patient profiles about the below-mentioned issues: Demographic characteristics; Disease characteristics; Concomitant diseases; Implemented drug treatments [ Time Frame: April - Dec 2010 ] [ Designated as safety issue: No ]
- To determine which and how frequent non-drug approaches are recommended in order to prevent COPD exacerbations [ Time Frame: April - Dec 2010 ] [ Designated as safety issue: No ]
| Enrollment: | 515 |
| Study Start Date: | April 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
COPD patients
|
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Chronic Obstructive Pulmonary Disease (COPD)
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
Contacts and Locations| Turkey | |
| Research Site | |
| Aksaray, Turkey | |
| Research Site | |
| Ankara, Turkey | |
| Research Site | |
| Antalya, Turkey | |
| Research Site | |
| Aydin, Turkey | |
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| Bilecik, Turkey | |
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| Bolu, Turkey | |
| Research Site | |
| Bursa, Turkey | |
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| Denizli, Turkey | |
| Research Site | |
| Elazig, Turkey | |
| Research Site | |
| Hatay, Turkey | |
| Research Site | |
| Istanbul, Turkey | |
| Research Site | |
| Izmir, Turkey | |
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| Kocaeli, Turkey | |
| Research Site | |
| Konya, Turkey | |
| Research Site | |
| Manisa, Turkey | |
| Research Site | |
| Rize, Turkey | |
| Research Site | |
| Samsun, Turkey | |
| Research Site | |
| Sanliurfa, Turkey | |
| Research Site | |
| Yozgat, Turkey | |
| Study Chair: | Tulin Kuyucu | Sureyyapasa Chest Disease Hospital |
More Information
No publications provided
| Responsible Party: | MC MD, AstrraZeneca |
| ClinicalTrials.gov Identifier: | NCT01110564 History of Changes |
| Other Study ID Numbers: | NIS-RTR-DUM-2009/1 |
| Study First Received: | April 23, 2010 |
| Last Updated: | January 27, 2011 |
| Health Authority: | Turkey: Ministry of Health |
Keywords provided by AstraZeneca:
|
Chronic Obstructive Pulmonary Disease daily symptom variability effects of symptom on morning activities |
Additional relevant MeSH terms:
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Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013