Symptoms and Physical Activity in COPD Patients in Europe

Completed

• Conditions: COPD

• Registration Number: NCT03031769
• Lead Sponsor: 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

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.

Study Timeline

• Study First Submitted: 2016-12-20
• Study Start: 2016-12-21
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2176

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
• 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 history of exacerbations (By GOLD definition) in last 12 months	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 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 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	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

Trial Locations

Locations (1)

Research site; 🇷🇴 Iasi, Romania