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Completed

NCT Number: NCT01110564

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

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aksaray, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: April - Dec 2010

Secondary outcomes

  1. 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

  2. To define COPD patient profiles about the below-mentioned issues: Demographic characteristics; Disease characteristics; Concomitant diseases; Implemented drug treatments

    Time frame: April - Dec 2010

  3. To determine which and how frequent non-drug approaches are recommended in order to prevent COPD exacerbations

    Time frame: April - Dec 2010

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 26, 2010
Registry last updated
Jan 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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