Clinical trial NCT01110564: Study to Investigate Daily Symptom Variability, Symptom Effects on Morning Activities of Chronic Obstructive Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
daily symptom variability
effects of symptom on morning activities
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-04-26
Enrollment: 515
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Obstructive Pulmonary Disease (COPD)

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.


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

Primary outcomes:
measure: To evaluate daily symptom variability in Chronic Obstructive Pulmonary Disease (COPD) patients
timeFrame: April - Dec 2010
Secondary outcomes:
measure: To evaluate effects of COPD symptoms on the morning activities of patients; To determine therapeutic expectations of patients and physicians in COPD
timeFrame: April - Dec 2010
measure: To define COPD patient profiles about the below-mentioned issues: Demographic characteristics; Disease characteristics; Concomitant diseases; Implemented drug treatments
timeFrame: April - Dec 2010
measure: To determine which and how frequent non-drug approaches are recommended in order to prevent COPD exacerbations
timeFrame: April - Dec 2010
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Aydin
country: Turkey
facility: Research Site
city: Bilecik
country: Turkey
facility: Research Site
city: Bolu
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Denizli
country: Turkey
facility: Research Site
city: Elazig
country: Turkey
facility: Research Site
city: Hatay
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Konya
country: Turkey
facility: Research Site
city: Manisa
country: Turkey
facility: Research Site
city: Rize
country: Turkey
facility: Research Site
city: Samsun
country: Turkey
facility: Research Site
city: Sanliurfa
country: Turkey
facility: Research Site
city: Yozgat
country: Turkey
facility: Research Site
Study officials:
affiliation: Sureyyapasa Chest Disease Hospital
name: Tulin Kuyucu
role: STUDY_CHAIR
References: