Chronic Obstructive Pulmonary DiseaseCOPD LIFENCT01325948

Cross-sectional Study to Investigate the Effects of Chronic Obstructive Pulmonary Disease on Daily Life Activities

An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 20 sites in Turkey (Türkiye).

Completed

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

Trial summary

The purpose of this study is to investigate the effects of Chronic Obstructive Pulmonary Disease (COPD) on daily life activities in patients with COPD and also to determine the socio-demographic profile, daily life style and needs of the patients with COPD. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease
How many people: 497 participants
Where: 20 sitesTurkey (Türkiye)
Study dates: Mar 2011to Jun 2011
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: Outpatients from health institutions where the patients with COPD are treated

Who may be able to join

Diagnosis of COPD
Outpatient treatment for any reason
Current or ex-smoker

Who cannot join

An exacerbation of COPD that still lasts or that was experienced within last 3 months
History of asthma and/or allergic rhinitis
The presence of another important respiratory disease

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Turkey (Türkiye)20 sites

Research Site
Adana
Research Site
Ankara
Research Site
Antalya
Research Site
Aydin
Research Site
Bartın
Research Site
Bolu
Research Site
Burdur
Research Site
Bursa
Research Site
Gaziantep
Research Site
Gebze
Research Site
Giresun
Research Site
Isparta
Research Site
Istanbul
Research Site
Izmir
Research Site
Karabük
Research Site
Kayseri
Research Site
Konya
Research Site
Manisa
Research Site
Mersin
Research Site
Yozgat

Other trials in Turkey (Türkiye)

About this study

Official title: Cross-sectional Observational Study to Investigate the Effects of Chronic Obstructive Pulmonary Disease on Daily Life Activities

Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
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 NCT01325948
Study group	Role	What they receive
Patients with COPD		Not described

What is being measured

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

Effect of COPD on daily activities
The distribution of the patients according to their answers, as Yes / No / Unknown, given to the questions of patient questionnaire about the effect of COPD on daily life and which daily activities are limited will be calculated as percentage.
Measured: 1 year

Secondary outcomes (1)

Patients' socio-demographic profiles, daily life conditions and needs and expectations from therapy
The answers the patients give to the questions about socio-demographic profiles, daily life conditions and needs and their expectations from the therapy will be summarized as percentages: Age and gender, educational background, place of residence, marital status and life conditions, concomitant diseases, smoking status, the diagnosis of COPD and its clinical characteristics basic knowledge of the patient about COPD daily life of the patient, expectations from the therapy.
Measured: Baseline

Timeline

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

Mar 2011Jun 2011

First posted30 Mar 2011 (estimated)
Study startMar 2011
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
Time perspective: Cross-sectional
Enrolment: 497 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01325948
Sponsor's protocol ID: NIS-RTR-XXX-2011/1
Acronym: COPD LIFE
Status last verified: Jul 2011
First submitted: 21 Mar 2011
Last updated: 21 Jul 2011
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

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cross-sectional Observational Study to Investigate the Effects of Chronic Obstructive Pulmonary Disease on Daily Life Activities
ClinicalTrials.gov ID: NCT01325948
Acronym / sponsor ID: COPD LIFE / NIS-RTR-XXX-2011/1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Study type: Observational
Recruitment status: Completed
Enrolment: 497 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 30 Mar 2011 (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

Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Patients with COPD	–	–

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Outpatients from health institutions where the patients with COPD are treated

Key inclusion criteria (3 listed)

Diagnosis of COPD
Outpatient treatment for any reason
Current or ex-smoker

Key exclusion criteria (3 listed)

An exacerbation of COPD that still lasts or that was experienced within last 3 months
History of asthma and/or allergic rhinitis
The presence of another important respiratory disease

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

Effect of COPD on daily activities
Time frame: 1 year
The distribution of the patients according to their answers, as Yes / No / Unknown, given to the questions of patient questionnaire about the effect of COPD on daily life and which daily activities are limited will be calculated as percentage.

1 secondary outcome

Patients' socio-demographic profiles, daily life conditions and needs and expectations from therapy
Time frame: Baseline

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 21 Jul 2011.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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.

Zeynep Goztas study director

AstraZeneca Turkey

Mehmet Polatli principal investigator

Adnan Menderes University Faculty of Medicine

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

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 20 sites in Turkey (Türkiye).

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 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Turkey (Türkiye). 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?

Effect of COPD on daily activities (time frame: 1 year). 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 NCT01325948.

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 21 Jul 2011.