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Pulmonary Disease, Chronic ObstructiveSTEP-COPDNCT03642613

The Study for Evaluating Factors Relating to Daily Step Counts and Physical Activity in Japanese Patients With COPD.

An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is conducted as a multicenter, non-interventional, cross-sectional study. Patients will be enrolled in the study by a continuous registration method after patients provide written informed consent. Read more about this study

Who is it for?
Any age
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
How many people
505 participants
Where
1 siteJapan
Study dates
14 Sep 2018to 15 Mar 2019
How long will I take part?
2 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 1. Patients who have provided written informed consent for participation in this study 2. Male and female patients aged at least 40 years at the time of enrolment who are given diagnosis of COPD by a physician (forced expiratory volume in one second/forced vital capacity [FEV1/FVC] of <70% after bronchodilators within the past one year or at the time of enrolment) 3. Patients whose respiratory function test values after bronchodilators are available 4. Patients whose DLCO values and data on the presence/absence of emphysema by a chest CT scan are available 5. Outpatients who are able to answer the questionnaires and start measurement with an activity meter within four weeks after informed consent and measure activities for 14 consecutive days

Who may be able to join

  • Patients who have provided written informed consent for participation in this study
  • Male and female patients aged at least 40 years at the time of enrolment who are given diagnosis of COPD by a physician*1
  • Patients whose respiratory function test values after bronchodilators (FEV1, FVC, IC) are available*2
  • Patients whose DLCO values and data on the presence/absence of emphysema by a chest CT scan are available*3
  • Outpatients who are able to answer the questionnaires and start measurement with an activity meter within four weeks after informed consent and measure activities for 14 consecutive days
  • 1: Guideline 12) should be referenced for the diagnostic criteria of COPD.
  • 2: Patients whose respiratory function test values after bronchodilators at the time of enrolment or within three months prior to enrolment are available. For patients on a bronchodilator as a long-term controller, respiratory function test values after bronchodilator in the morning of the test are acceptable.
  • 3: This refers to patients who have undergone tests within past one year.

Who cannot join

  • Patients who have participated in any other interventional studies such as clinical trials within the past eight weeks
  • Patients determined to be inappropriate to be enrolled in this study by investigators because they cannot comply with the procedures, limitations, and requirements of this study, or for other reasons.
  • Patients with an exacerbation of COPDa within the past eight weeks a Exacerbation of COPD: Conditions with increased shortness of breath, increased cough and sputum, occurrence of chest discomfort/uneasiness or its intensification, and which require changes in treatment on disease stable state, excluding cases where there is any other precedent disease (heart failure, pneumothorax, pulmonary thromboembolism, etc.).
  • Patients who require home oxygen therapy (excluding those who use it only during nighttime)

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Tohoku University School of Medicine

    Sendai, Miyagi, 9808574

Other trials in Japan

About this study

Official title: A Non-interventional, Cross-sectional Study for Evaluating Factors Relating to Daily Step Counts and Physical Activity in Japanese Patients With COPD.

This study is conducted as a multicenter, non-interventional, cross-sectional study. Patients will be enrolled in the study by a continuous registration method after patients provide written informed consent. After providing informed consent, patients will answer the questionnaires and start measurement with an accelerometer within four weeks. Activities will be measured for 14 consecutive days.

Read the detailed description

This study is conducted as a multicenter, non-interventional, cross-sectional study. Patients will be enrolled in the study by a continuous registration method after patients provide written informed consent. After providing informed consent, patients will answer the questionnaires and start measurement with an accelerometer within four weeks. Activities will be measured for 14 consecutive days.

<Objectives>

  • Evaluation of factors relating to physical activity level in COPD patients.
  • Evaluation of the number of daily steps in subgroups of COPD patients grouped according to patient characteristics including lung functions, mMRC, and CAT scores.
  • Elucidation of impacts of factors associating PAL in COPD patients.
  • Elucidating exploratorily the characteristics of the patients who are distributed differently in each factor and analyzing patients' PAL further with their background.
Keywords
COPD, RWE, Physical Activity
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical activity level

    Physical activity level will be assessed as average daily duration (min) of ≧2 metabolic equivalents (METs)

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start14 Sep 2018
  3. Primary completion15 Mar 2019
  4. Study completion15 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
505 participants (actual)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT03642613
Sponsor's protocol ID
D5980R00006
Acronym
STEP-COPD
Status last verified
Sep 2020
First submitted
9 Aug 2018
Last updated
14 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ichinose M, Minakata Y, Motegi T, Takahashi T, Seki M, Sugaya S, Hayashi N, Kuwahira I. A Non-Interventional, Cross-Sectional Study to Evaluate Factors Relating to Daily Step Counts and Physical Activity in Japanese Patients with Chronic Obstructive Pulmonary Disease: STEP COPD. Int J Chron Obstruct Pulmon Dis. 2020 Dec 22;15:3385-3396. doi: 10.2147/COPD.S277782. eCollection 2020.

    PubMed 33376319

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity level (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03642613, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.

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