Perception of Symptom Variability in COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01753427
First received: December 13, 2012
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

The objective of the study is to assess patient's perception with stable state COPD on symptom variability and to describe how symptom variability impacts daily quality of life in Chinese COPD patient with moderate, severe or very severe airflow limitation from tier 3 hospitals in China where most of COPD patients are diagnosed and treated.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Perception of Symptom Variability in Chinese COPD Patients

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The variability of symptoms due to COPD throughout the day [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    • To ask subject, which symptoms(breathlessness, chest tightness, coughing, wheezing, phlegm)is COPD symptoms and exist throughout the day
    • To ask subject , whether COPD symptoms variability throughout the day exists or not ;
    • To ask subject , which (on waking, later in the morning, in the afternoon, in the evening, at night) is the most likely occurring time of these symptoms;
    • To ask subject , Which (on waking, later in the morning, in the afternoon, in the evening, at night) is the most troublesome time of these symptoms.


Secondary Outcome Measures:
  • The impact of COPD symptoms on patient's daily living activities and sleep quality [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    • To ask subject, Whether essential daily activities affected by COPD symptoms and the type of following: going up and downstairs, Going out of shopping, doing sport/exercise, doing housework, or all of these
    • To ask subject, Whether sleep quality affected by COPD symptoms and the type of following: difficulty falling sleep, frequent waking during night, early waking in the morning, or all of these

  • The impact of COPD symptoms on morning activities [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    • To ask subject, When [getting out of bed, dressing, washing, eating breakfast, morning activity after breakfast (indoor activity, including housework) , morning exercise (outdoor activity, such as walking, sport, etc)] the essential morning activities affected by COPD symptoms:
    • To ask subject, The extent of these morning activities affected: not at all, a little, moderate, severe, extremely severe resulting to feel difficult to complete independently, extremely severe resulting to complete under others help or cannot complete at all

  • Total CAT score [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    CAT (COPD assessment test) has a broader coverage of the impact of COPD on the patient's daily life and well-being.

  • Total MMRC score [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    MMRC (Modified Medical Research Council Questionnaire for Assessing the Severity of Breathlessness) assesses disability due to breathlessness.

  • Patient's perception on COPD and COPD treatments [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    • To ask subject, Seek for treatment only when symptoms occur/worsening or regularly visit physician and take medicine(s)
    • To ask subject, Whether Knowing about how and when to use their medications
    • To ask subject, Usually taking their medication(s) required by physician to be used in the morning at what time: before getting out of bed, within 30 minutes after getting out of bed, within 30 minutes to 1 hour after getting out of bed, over 1 hour after getting out of bed, no regular time


Estimated Enrollment: 1000
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Out-patient, male or female aged 40 years and over and Clinical diagnosis of COPD at least 6 months

Criteria

Inclusion Criteria:

  • Provision of subject informed consent
  • Out-patient
  • Clinical diagnosis of COPD at least 6 months
  • Lung function based on data available within 3 months in medical records confirming FEV1<80% normal predicted (post-bronchodilator) and FEV1/FVC<0.7 (post-bronchodilator)

Exclusion Criteria:

  • Participation in any interventional study involving investigational drugs; Patient inability to understand the study procedures or inability/reluctance to answer questionnaire
  • Ongoing exacerbation of COPD or exacerbation within the previous 3 months. An exacerbation is defined as a worsening of COPD symptoms leading to a treatment with antibiotics and/or a short course of system steroids and/or hospitalisation or emergency
  • History of asthma and/or allergic rhinitis, Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis
  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: NCT01753427

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Tianjin
Research Site
Tianjin, Tianjin, China
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01753427     History of Changes
Other Study ID Numbers: NIS-RCN-XXX-2012/1
Study First Received: December 13, 2012
Last Updated: December 12, 2013
Health Authority: China: Ethics Committee

Keywords provided by AstraZeneca:
COPD,
symptoms,
Non-Interventional study,

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 30, 2014