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Symptoms and Physical Activity in COPD Patients in Europe (SPACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031769
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
An observational, multinational, cross sectional study to describe 24-hs symptoms, physical activity and their relationship in stable COPD patients in Europe

Condition or disease
COPD

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 2176 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Symptoms and Physical Activity in COPD Patients in Europe
Actual Study Start Date : December 21, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and physical activity level (YPAS questionnaire) on day 1 [ Time Frame: Day 1 ]
  2. • 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 ]
  3. • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and disease classification (By GOLD recommendation) on day 1 [ Time Frame: Day 1 ]
  4. • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and level of dyspnea level (mMRC) on day 1 [ Time Frame: Day 1 ]
  5. • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and HRQoL (CAT) on day 1 [ Time Frame: Day 1 ]
  6. • Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and history of exacerbations (By GOLD definition) in last 12 months [ Time Frame: Day 1 ]
  7. • 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 ]
  8. • Relationship between physical activity levels (YPAS questionnaire) and disease classification (By GOLD recommendation) on day 1 [ Time Frame: Day 1 ]
  9. • Relationship between physical activity levels (YPAS questionnaire) and level of dyspnea level (mMRC) on day 1 [ Time Frame: Day 1 ]
  10. • Relationship between physical activity levels (YPAS questionnaire) and HRQoL (CAT) on day 1 [ Time Frame: Day 1 ]
  11. • Relationship between physical activity levels (YPAS questionnaire) and history of exacerbations (By GOLD definition) in last 12 months [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female ambulatory patients aged over 40 years diagnosed with stable COPD according 2013 GOLD criteria
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031769


Locations
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Romania
Research site
Iasi, Romania
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Chair: Florin D Mihaltan, MD,PhD Institute Marius Nasta, Bucharest
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03031769    
Other Study ID Numbers: D5970R00006
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017