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Study to Investigate Daily Symptom Variability, Symptom Effects on Morning Activities of Chronic Obstructive Disease

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01110564
First received: April 23, 2010
Last updated: January 27, 2011
Last verified: January 2011
  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
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To evaluate daily symptom variability in Chronic Obstructive Pulmonary Disease (COPD) patients [ Time Frame: April - Dec 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

Chronic Obstructive Pulmonary Disease (COPD)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110564

Locations
Turkey
Research Site
Aksaray, Turkey
Research Site
Ankara, Turkey
Research Site
Antalya, Turkey
Research Site
Aydin, Turkey
Research Site
Bilecik, Turkey
Research Site
Bolu, Turkey
Research Site
Bursa, Turkey
Research Site
Denizli, Turkey
Research Site
Elazig, Turkey
Research Site
Hatay, Turkey
Research Site
Istanbul, Turkey
Research Site
Izmir, Turkey
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
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:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 24, 2014