Chronic Obstructive Pulmonary Disease (COPD)NCT00722267

European Non-interventional Study in Chronic Obstructive Pulmonary Disease (COPD) Patients

An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 606 sites in 17 countries.

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 investigating how patients with severe stable state COPD perceive the variability of their symptoms throughout the day, the week and the year; the impact of these variations on their daily activities or sleep quality and how they deal with their treatments. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
How many people: 7,400 participants
Where: 606 sitesin 17 countries
Study dates: Jul 2008to Feb 2009
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participating physicians (GPs and Respiratory physicians) will be asked to recruit 4 patients (on average). The first patients presenting for a consultation for any reason, who meet eligibility criteria, and give informed consent, should be enrolled.

Who may be able to join

Outpatients with a diagnosis of COPD
FEV1<50% and FEV1/FVC<0.7 according to lung function data in medical records.
Smoker or ex-smoker > 10 pack-years
Informed consent obtained

Who cannot join

Ongoing exacerbation of COPD or within the previous 3 months
Any other significant respiratory disease (including asthma and allergic rhinitis)

Trial locations and contacts

606 sites in 17 countries.

Country

City, postcode or hospital

606 sites in 17 countries

France161 sites

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Agde
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About this study

Official title: Patient Perception of Symptom Variability. A Cross-sectional Study of Patients With Severe COPD.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: severe COPD, COPD symptoms, variability of symptoms, patient's perception
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What is being measured

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

Patient's perception of the variability of symptoms due to severe stable state COPD throughout the day, the week and the year
Measured: Once

Secondary outcomes (3)

Impact of symptoms (and variability of symptoms) on the patient's morning & daily living activities and sleep quality.
Measured: Once
Describe how patient use their COPD treatment
Measured: Once
Factors that may influence the patient's perception of symptom variability
Measured: Once

Timeline

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

Jul 2008Feb 2009

First posted25 Jul 2008 (estimated)
Study startJul 2008
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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: Cross-sectional
Enrolment: 7,400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00722267
Sponsor's protocol ID: NIS-REU-DUM-2007/1
Status last verified: Jul 2009
First submitted: 23 Jul 2008
Last updated: 22 Jan 2020
Results posted: No
Data monitoring committee: No

Publications

Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.
PubMed 21115606

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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Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
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Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
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 recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia

All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Perception of Symptom Variability. A Cross-sectional Study of Patients With Severe COPD.
ClinicalTrials.gov ID: NCT00722267
Acronym / sponsor ID: NIS-REU-DUM-2007/1
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: severe COPD, COPD symptoms, variability of symptoms, patient's perception
Study type: Observational
Recruitment status: Completed
Enrolment: 7,400 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2008
Study completion: Feb 2009 (actual)
First posted: 25 Jul 2008 (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.

Study design

Observational model: Case only
Time perspective: Cross-sectional

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participating physicians (GPs and Respiratory physicians) will be asked to recruit 4 patients (on average). The first patients presenting for a consultation for any reason, who meet eligibility criteria, and give informed consent, should be enrolled.

Key inclusion criteria (4 listed)

Outpatients with a diagnosis of COPD
FEV1<50% and FEV1/FVC<0.7 according to lung function data in medical records.
Smoker or ex-smoker > 10 pack-years
Informed consent obtained

Key exclusion criteria (2 listed)

Ongoing exacerbation of COPD or within the previous 3 months
Any other significant respiratory disease (including asthma and allergic rhinitis)

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

Patient's perception of the variability of symptoms due to severe stable state COPD throughout the day, the week and the year
Time frame: Once

3 secondary outcomes

Impact of symptoms (and variability of symptoms) on the patient's morning & daily living activities and sleep quality.
Time frame: Once
Describe how patient use their COPD treatment
Time frame: Once
Factors that may influence the patient's perception of symptom variability
Time frame: Once

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 Jan 2020.
Derived from this study: PubMed 21115606Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.

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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.

The record lists no contact. Use the official record to reach the sponsor.

606 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 606 sites in 17 countries.

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 4 inclusion and 2 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 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 606 sites in France, Germany, Spain, Belgium, Italy and 12 more countries. 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?

Patient's perception of the variability of symptoms due to severe stable state COPD throughout the day, the week and the year (time frame: Once). 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 NCT00722267, 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 22 Jan 2020.