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Completed

NCT Number: NCT03031769

Symptoms and Physical Activity in COPD Patients in Europe

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

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Key information

Conditions

COPD 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–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research site

Iași, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients aged 40 years or older.
  • Patient has diagnosis of COPD for 1 year or more.
  • Patient has at least one spirometry with COPD criteria, fixed ratio <0.70 post BD, in previous 12 months
  • Patient is a current smoker or an ex-smoker with a smoking history of ≥ 10 pack- years.
  • 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)
  • Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol
  • 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

  • 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)
  • 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
  • Patient is participating in an ongoing clinical trial that might, in the investigator's opinion, influence the assessment for SPACE study

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: SPACE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2017
Registry last updated
Oct 2, 2017

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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