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

AstraZeneca logo

AstraZeneca

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Study type

Observational

Funder types

Industry

Identifiers

NCT01110564
NIS-RTR-DUM-2009/1

Details and patient eligibility

About

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.

Enrollment

515 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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

Trial design

515 participants in 1 patient group

1
Description:
COPD patients

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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