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Completed

NCT Number: NCT01753427

Perception of Symptom Variability in COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. The variability of symptoms due to COPD throughout the day

    Time frame: Day 1

    • 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 outcomes

  1. The impact of COPD symptoms on patient's daily living activities and sleep quality

    Time frame: Day 1

    • 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

  2. The impact of COPD symptoms on morning activities

    Time frame: Day 1

    • 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

  3. Total CAT score

    Time frame: Day 1

    CAT (COPD assessment test) has a broader coverage of the impact of COPD on the patient's daily life and well-being.

  4. Total MMRC score

    Time frame: Day 1

    MMRC (Modified Medical Research Council Questionnaire for Assessing the Severity of Breathlessness) assesses disability due to breathlessness.

  5. Patient's perception on COPD and COPD treatments

    Time frame: Day 1

    • 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Perception of Symptom Variability in Chinese COPD Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2012
Registry last updated
Jun 15, 2016

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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