COPDCLOUDNCT02346292

Observational Multicenter Non-interventional Study on COPD Patients Treatment Strategies at the Time of Hospital Discharge and Within 12 Months of Follow-up on an Outpatient Primary Care Basement

An observational study of COPD, run by AstraZeneca at 30 sites in Russia.

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

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
How many people: 1,250 participants
Where: 30 sitesRussia
Study dates: 31 Mar 2015to 30 Dec 2016
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients of both genders aged 40 years and older, smokers, with smoking history more than 10 pack-years, with severe and very severe COPD who were hospitalized with COPD exacerbation

Who may be able to join

Signed informed consent . Men and women at least 40 years old, with smoking history more than 10 pack-years.
Hospitalization for the reason of COPD exacerbation (exacerbation defined as acute condition, different from typical fluctuations of general condition and requiring change of therapy).
Diagnosis of severe or very severe COPD based on final spirometry (performed in a standardized manner using salbutamol 400 mg), or history of diagnosis of severe or very severe COPD based on spirometry performed during 6 months before the hospitalization.

Who cannot join

Participation in any interventional study.
Concomitant respiratory diseases, i.e. confirmed or suspected malignancy or any other serious condition, including lung tumor, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis.
Patient is unable or unwilling to complete questionnaires, unable to understand study procedures, or other reasons which, in the investigator's opinion, could affect study procedures performance.

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

Russia30 sites

Research Site
Barnaul
Research Site
Blagoveshchensk
Research Site
Chelyabinsk
Research Site
Cherepovets
Research Site
Chita
Research Site
Gatchina
Research Site
Izhevsk
Research Site
Kazan'
Research Site
Kemerovo
Research Site
Kirov
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Kursk
Research Site
Moscow
Research Site
Naberezhnye Chelny
Research Site
Novokuznetsk
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Oryol
Research Site
Petrozavodsk
Research Site
Rostov-on-Don
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Seversk
Research Site
Smolensk
Research Site
Ufa
Research Site
Voronezh
Research Site
Yakutsk
Research Site
Yaroslavl
Research Site
Yekaterinburg

Other trials in Russia

About this study

The study is an observational multicenter descriptive study. It is planned to enroll approximately 1250 subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation into departments of pulmonology or therapy. The study will be conducted in approximately 20-25 institutions of treatment and prevention in Russian Federation and will include about 50 to 60 subject at each clinical site.

Read the detailed description

The study is an observational multicenter descriptive study. It is planned to enroll approximately 1000 subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation into departments of pulmonology or therapy. The study will be conducted in approximately 20-25 institutions of treatment and prevention in Russian Federation and will include about 50 to 60 subject at each clinical site.

This is an observational study, so there is no treatment protocol or subjects' management recommendations required. The study subjects receive medical treatment according to the routine practice for their disease in Russian Federation. A subject's participation in this clinical study should not affect character and amount of care provided according to the routine clinical practice.

The study includes 5 clinical visits: Study Enrolment Visit, Month 3 Visit, Month 6 visit, Month 9 Visit, Month 12 visit / End of Study Visit.

Conditions: COPD
Keywords: COPD, Spirometry, severe and very severe COPD, COPD exacerbations, therapy schemes, therapy changes
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02346292
Study group	Role	What they receive
1		Patients of both genders aged 40 years and older, smokers, with smoking history more than 10 pack-years, with severe and very severe COPD who were hospitalized with COPD exacerbation

What is being measured

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

Percentage of subjects with severe and very severe COPD who received prescription of therapy, including different schemes of inhaled glucocorticoids use, according to main principles of COPD therapy (GOLD 2014 recommendations)
Measured: up to 12 months

Secondary outcomes (10)

Description of social characteristics (days of disability, etc.), economical status of subjects if applicable (if patient agreed) (average monthly income) with severe and very severe COPD hospitalized for the reason of COPD exacerbation
Measured: at the time of 1st visit
% of subjects with severe and very severe COPD for whom scheme of inhaled glucocorticoids use was changed after 3, 6, 9, and 12 months of follow-up (outpatient conditions after discharge from the hospital)
Measured: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
Frequency and reasons of treatment scheme correction during follow-up after its prescription at the moment of discharge from the hospital
As reasons of treatment changes and/or its correction it will be measured with:
1. Number of hospitalizations in the previous 3 months before enrollment and in 3, 6, 9, 12 months;
2. Number or emergency calls, outpatient care settings visits in the previous 3 months before enrollment and in 3, 6, 9, 12 months;
3. Number of exacerbations and number of related hospitalizations in the previous 3 months before enrollment and in 3, 6, 9, 12 months.
4. Number of pneumonia cases in the previous 3 months before enrollment and in 3, 6, 9, 12 months.
Measured: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
% of subjects with severe and very severe COPD who during the follow-up period attended medical institution for the correction of treatment scheme prescribed at the moment of discharge from the hospital
Measured: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
% of subjects with severe and very severe COPD, received treatment with short acting anticholinergic drugs, SABA, LABA, LAMA, oral CS, FDC, phosphodiesterase type 4 inhibitors, theophylline
Measured: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
% of patients with asthma-COPD overlap syndrome among all subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation
Measured: at the time of 1st visit and 12 months of follow-up
% of subjects with asthma-COPD overlap syndrome who received treatment with inhaled glucocorticoids both
Measured: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
% of patients with severe and very severe COPD, who received treatment with short acting anticholinergic drugs, SABA, LABA, LAMA, oral CS, FDC, phosphodiesterase type 4 inhibitors, theophylline, among all subjects with ACOS
Measured: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
EQ-5D results
Measured: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
CAT results
Measured: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up

Timeline

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

31 Mar 201530 Dec 2016

First posted27 Jan 2015 (estimated)
Study start31 Mar 2015
Primary completion30 Dec 2016
Study completion30 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Case only
Time perspective: Retrospective
Enrolment: 1,250 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02346292
Sponsor's protocol ID: NIS-RRU-XXX-2014/1
Acronym: CLOUD
Status last verified: Dec 2017
First submitted: 14 Jan 2015
Last updated: 22 Dec 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Multicenter Non-interventional Study on COPD Patients Treatment Strategies at the Time of Hospital Discharge and Within 12 Months of Follow-up on an Outpatient Primary Care Basement
ClinicalTrials.gov ID: NCT02346292
Acronym / sponsor ID: CLOUD / NIS-RRU-XXX-2014/1
Conditions: COPD
Keywords: COPD, Spirometry, severe and very severe COPD, COPD exacerbations, therapy schemes, therapy changes
Study type: Observational
Recruitment status: Completed
Enrolment: 1,250 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 31 Mar 2015 (actual)
Primary completion: 30 Dec 2016 (actual)
Study completion: 30 Dec 2016 (actual)
First posted: 27 Jan 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study includes 5 clinical visits: Study Enrolment Visit, Month 3 Visit, Month 6 visit, Month 9 Visit, Month 12 visit / End of Study Visit.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
1	–	–Patients of both genders aged 40 years and older, smokers, with smoking history more than 10 pack-years, with severe and very severe COPD who were hospitalized with COPD exacerbation

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients of both genders aged 40 years and older, smokers, with smoking history more than 10 pack-years, with severe and very severe COPD who were hospitalized with COPD exacerbation

Key inclusion criteria (3 listed)

Signed informed consent . Men and women at least 40 years old, with smoking history more than 10 pack-years.
Hospitalization for the reason of COPD exacerbation (exacerbation defined as acute condition, different from typical fluctuations of general condition and requiring change of therapy).
Diagnosis of severe or very severe COPD based on final spirometry (performed in a standardized manner using salbutamol 400 mg), or history of diagnosis of severe or very severe COPD based on spirometry performed during 6 months before the hospitalization.

Key exclusion criteria (3 listed)

Participation in any interventional study.
Concomitant respiratory diseases, i.e. confirmed or suspected malignancy or any other serious condition, including lung tumor, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis.
Patient is unable or unwilling to complete questionnaires, unable to understand study procedures, or other reasons which, in the investigator's opinion, could affect study procedures performance.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of subjects with severe and very severe COPD who received prescription of therapy, including different schemes of inhaled glucocorticoids use, according to main principles of COPD therapy (GOLD 2014 recommendations)
Time frame: up to 12 months

10 secondary outcomes

Description of social characteristics (days of disability, etc.), economical status of subjects if applicable (if patient agreed) (average monthly income) with severe and very severe COPD hospitalized for the reason of COPD exacerbation
Time frame: at the time of 1st visit
% of subjects with severe and very severe COPD for whom scheme of inhaled glucocorticoids use was changed after 3, 6, 9, and 12 months of follow-up (outpatient conditions after discharge from the hospital)
Time frame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
Frequency and reasons of treatment scheme correction during follow-up after its prescription at the moment of discharge from the hospital
Time frame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
% of subjects with severe and very severe COPD who during the follow-up period attended medical institution for the correction of treatment scheme prescribed at the moment of discharge from the hospital
Time frame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
% of subjects with severe and very severe COPD, received treatment with short acting anticholinergic drugs, SABA, LABA, LAMA, oral CS, FDC, phosphodiesterase type 4 inhibitors, theophylline
Time frame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
% of patients with asthma-COPD overlap syndrome among all subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation
Time frame: at the time of 1st visit and 12 months of follow-up
% of subjects with asthma-COPD overlap syndrome who received treatment with inhaled glucocorticoids both
Time frame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
% of patients with severe and very severe COPD, who received treatment with short acting anticholinergic drugs, SABA, LABA, LAMA, oral CS, FDC, phosphodiesterase type 4 inhibitors, theophylline, among all subjects with ACOS
Time frame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
EQ-5D results
Time frame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up
CAT results
Time frame: at the moment of discharge and after 3, 6, 9, and 12 months of follow-up

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
CSR SynopsisLink provided by the sponsor.

Related trials for COPD

RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruiting
A TwiCs Study of TCM Management Based on Cardiopulmonary Screening in COPD
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Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexander Bedenkov, Medical Director study director

AstraZeneca

Sergey Avdeev, MD, PHD principal investigator

Federal State Institution "Scientific Research Institute of Pulmonology" FMBA of Russia

Andrey Belevsky, PHD principal investigator

Federal State Institution "Scientific Research Institute of Pulmonology" FMBA of Russia

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COPD, run by AstraZeneca at 30 sites in Russia.

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 3 inclusion and 3 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 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Russia. 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?

Percentage of subjects with severe and very severe COPD who received prescription of therapy, including different schemes of inhaled glucocorticoids use, according to main principles of COPD therapy (GOLD 2014 recommendations) (time frame: up to 12 months). 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 NCT02346292.

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 22 Dec 2017.