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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03031769 |
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Date of registration:
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20/12/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Symptoms and Physical Activity in COPD Patients in Europe
SPACE |
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Scientific title:
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Symptoms and Physical Activity in COPD Patients in Europe |
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Date of first enrolment:
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December 21, 2016 |
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Target sample size:
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2176 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03031769 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Romania
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Contacts
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Name:
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Florin D Mihaltan, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute Marius Nasta, Bucharest |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or female patients aged 40 years or older.
2. Patient has diagnosis of COPD for 1 year or more.
3. Patient has at least one spirometry with COPD criteria, fixed ratio <0.70 post BD, in
previous 12 months
4. Patient is a current smoker or an ex-smoker with a smoking history of = 10 pack-
years.
5. Stable patients, as stated in medical records or patient reports during visit, defined
as: without exacerbation treatment at study visit neither in the previous 2 months,
and without changes in maintenance COPD treatment regimen over the preceding 2 months
(avoid first consult patient)
6. Patients must be able and willing to read and comprehend written instructions, and
comprehend and complete the questionnaires required by the protocol
7. After full explanation, patients must have signed an informed consent document
indicating that they understand the purpose of and the procedures required for the
study and are willing to participate in the study.
Exclusion Criteria:
1. Patient has diagnosis of sleep apnea syndrome or other chronic respiratory disease
different from chronic obstructive diseases. (except for non-idiopathic pulmonary
fibrosis and ACOS, only if the main diagnosis is COPD)
2. An acute or chronic condition that, in the investigator's opinion, would limit the
patient's ability to complete questionnaires or participate in this study
3. Patient is participating in an ongoing clinical trial that might, in the
investigator's opinion, influence the assessment for SPACE study
Age minimum:
40 Years
Age maximum:
130 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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COPD
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Primary Outcome(s)
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Proportion of patients experiencing symptoms (previous 24 hours) and insufficient physical activity levels (previous month) despite being treated for COPD in real life setting.
[Time Frame: Day 1]
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Secondary Outcome(s)
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• Relationship between physical activity levels (YPAS questionnaire) and HRQoL (CAT) on day 1
[Time Frame: Day 1]
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and level of dyspnea level (mMRC) on day 1
[Time Frame: Day 1]
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and history of exacerbations (By GOLD definition) in last 12 months
[Time Frame: Day 1]
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and physical activity level (YPAS questionnaire) on day 1
[Time Frame: Day 1]
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and adherence to respiratory medication (SRSI for patients and inhalers technique assessed by investigators) on day 1
[Time Frame: Day 1]
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• Relationship between physical activity levels (YPAS questionnaire) and history of exacerbations (By GOLD definition) in last 12 months
[Time Frame: Day 1]
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and HRQoL (CAT) on day 1
[Time Frame: Day 1]
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and disease classification (By GOLD recommendation) on day 1
[Time Frame: Day 1]
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• Relationship between physical activity levels (YPAS questionnaire) and disease classification (By GOLD recommendation) on day 1
[Time Frame: Day 1]
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• Relationship between physical activity levels (YPAS questionnaire) and adherence to respiratory medication (SRSI for patients and inhalers technique assessed by investigators) on day 1
[Time Frame: Day 1]
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• Relationship between physical activity levels (YPAS questionnaire) and level of dyspnea level (mMRC) on day 1
[Time Frame: Day 1]
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Secondary ID(s)
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D5970R00006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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