Chronic Obstructive Pulmonary DiseaseNCT01753427
Perception of Symptom Variability in COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 6 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 1,058 participants
- Where
- 6 sitesChina
- Study dates
- Dec 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Out-patient, male or female aged 40 years and over and Clinical diagnosis of COPD at least 6 months
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Research Site
Beijing, Beijing Municipality
Research Site
Chengdu, Sichuan
Research Site
Guangzhou, Guangdong
Research Site
Shanghai, Shanghai Municipality
Research Site
Tianjin, Tianjin Municipality
Research Site
Wuhan, Hubei
About this study
Official title: Perception of Symptom Variability in Chinese COPD Patients
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD,, symptoms,, Non-Interventional study,
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
The variability of symptoms due to COPD throughout the day
- 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.
Measured: Day 1
Secondary outcomes (5)
The impact of COPD symptoms on patient's daily living activities and sleep quality
- 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
Measured: Day 1
The impact of COPD symptoms on morning activities
- 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
Measured: Day 1
Total CAT score
CAT (COPD assessment test) has a broader coverage of the impact of COPD on the patient's daily life and well-being.
Measured: Day 1
Total MMRC score
MMRC (Modified Medical Research Council Questionnaire for Assessing the Severity of Breathlessness) assesses disability due to breathlessness.
Measured: Day 1
Patient's perception on COPD and COPD treatments
- 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,058 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753427
- Sponsor's protocol ID
- NIS-RCN-XXX-2012/1
- Status last verified
- Jun 2016
- First submitted
- 13 Dec 2012
- Last updated
- 15 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Symptom Variability in Chinese COPD Patients
- ClinicalTrials.gov ID
- NCT01753427
- Acronym / sponsor ID
- NIS-RCN-XXX-2012/1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD,, symptoms,, Non-Interventional study,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,058 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out-patient, male or female aged 40 years and over and Clinical diagnosis of COPD at least 6 months
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
The impact of COPD symptoms on patient's daily living activities and sleep quality
Time frame: Day 1
The impact of COPD symptoms on morning activities
Time frame: Day 1
Total CAT score
Time frame: Day 1
Total MMRC score
Time frame: Day 1
Patient's perception on COPD and COPD treatments
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The variability of symptoms due to COPD throughout the day (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.