Symptoms and Physical Activity in COPD Patients in Europe

COPD Clinical Trial

— SPACE  

Official title:

Symptoms and Physical Activity in COPD Patients in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031769
• Other study ID #: D5970R00006
• Status: Completed
• Phase: N/A
• First received: December 20, 2016
• Last updated: September 29, 2017
• Start date: December 21, 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2176
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
Romania	Research site	Iasi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and physical activity level (YPAS questionnaire) on day 1		Day 1
Secondary	• 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
Secondary	• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and disease classification (By GOLD recommendation) on day 1		Day 1
Secondary	• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and level of dyspnea level (mMRC) on day 1		Day 1
Secondary	• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and HRQoL (CAT) on day 1		Day 1
Secondary	• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and history of exacerbations (By GOLD definition) in last 12 months		Day 1
Secondary	• 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
Secondary	• Relationship between physical activity levels (YPAS questionnaire) and disease classification (By GOLD recommendation) on day 1		Day 1
Secondary	• Relationship between physical activity levels (YPAS questionnaire) and level of dyspnea level (mMRC) on day 1		Day 1
Secondary	• Relationship between physical activity levels (YPAS questionnaire) and HRQoL (CAT) on day 1		Day 1
Secondary	• Relationship between physical activity levels (YPAS questionnaire) and history of exacerbations (By GOLD definition) in last 12 months		Day 1