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An observational, multinational, cross sectional study to describe 24-hs symptoms, physical activity and their relationship in stable COPD patients in Europe
The study is a multi-centre, multi country, observational prospective cross sectional study to determine the prevalence and severity of early morning, day and night-time symptoms and physical activity patterns and to evaluate their correlation between each other and with disease severity, adherence to respiratory medications, direct costs and PROs in patients with stable COPD in Europe.
Approximately 2000 patients will be enrolled in convenient sites in several (9-12) selected countries.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients experiencing symptoms (previous 24 hours) and insufficient physical activity levels (previous month) despite being treated for COPD in real life setting. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and physical activity level (YPAS questionnaire) on day 1 | Day 1 | |
| • 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female ambulatory patients aged over 40 years diagnosed with stable COPD according 2013 GOLD criteria
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| Name | Affiliation | Role |
|---|---|---|
| Florin D Mihaltan, MD,PhD | Institute Marius Nasta, Bucharest | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Iași | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34522093 | Derived | Mihaltan F, Rajnoveanu RM, Arghir OC, Alecu S, Postolache PA. High 24-Hour Respiratory Symptoms and Low Physical Activity in the Stable COPD Romanian Cohort of SPACE Study. Int J Chron Obstruct Pulmon Dis. 2021 Sep 6;16:2533-2544. doi: 10.2147/COPD.S321197. eCollection 2021. | |
| 34252000 | Derived | De Bontridder S, Corhay JL, Haenebalcke C, Fievet F, Etienne I, Vanderhelst E. Correlation of symptoms and physical activity level in chronic obstructive pulmonary disease patients: results from the observational SPACE study. Acta Clin Belg. 2022 Jun;77(3):671-678. doi: 10.1080/17843286.2021.1950419. Epub 2021 Jul 12. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Day 1 |
| • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and disease classification (By GOLD recommendation) on day 1 | Day 1 |
| • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and level of dyspnea level (mMRC) on day 1 | Day 1 |
| • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and HRQoL (CAT) on day 1 | Day 1 |
| • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and history of exacerbations (By GOLD definition) in last 12 months | Day 1 |
| • Relationship between physical activity levels (YPAS questionnaire) and adherence to respiratory medication (SRSI for patients and inhalers technique assessed by investigators) on day 1 | Day 1 |
| • Relationship between physical activity levels (YPAS questionnaire) and disease classification (By GOLD recommendation) on day 1 | Day 1 |
| • Relationship between physical activity levels (YPAS questionnaire) and level of dyspnea level (mMRC) on day 1 | Day 1 |
| • Relationship between physical activity levels (YPAS questionnaire) and HRQoL (CAT) on day 1 | Day 1 |
| • Relationship between physical activity levels (YPAS questionnaire) and history of exacerbations (By GOLD definition) in last 12 months | Day 1 |
| 31088560 | Derived | Mihaltan F, Adir Y, Antczak A, Porpodis K, Radulovic V, Pires N, de Vries GJ, Horner A, De Bontridder S, Chen Y, Shavit A, Alecu S, Adamek L. Importance of the relationship between symptoms and self-reported physical activity level in stable COPD based on the results from the SPACE study. Respir Res. 2019 May 14;20(1):89. doi: 10.1186/s12931-019-1053-7. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |