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Symptoms and Physical Activity in COPD Patients in Europe

NCT ID: NCT03031769

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-21

Study Completion Date

2017-08-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florin D Mihaltan, MD,PhD

Role: STUDY_CHAIR

Institute Marius Nasta, Bucharest

Locations

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Research site

Iași, , Romania

Site Status

Countries

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Romania

References

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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.

Reference Type DERIVED
PMID: 34522093 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34252000 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31088560 (View on PubMed)

Other Identifiers

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D5970R00006

Identifier Type: -

Identifier Source: org_study_id