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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00292552




Registration number
NCT00292552
Ethics application status
Date submitted
14/02/2006
Date registered
16/02/2006
Date last updated
23/03/2017

Titles & IDs
Public title
Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints
Scientific title
A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time
Secondary ID [1] 0 0
SCO104960
Universal Trial Number (UTN)
Trial acronym
ECLIPSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Novel endpoint determination

COPD subjects - Subjects with GOLD stage II-IV COPD

Smoker controls - Subjects with smoking history but normal lung function

Non-smoker controls - Normal healthy non-smokers


Other interventions: Novel endpoint determination
Novel endpoint determination
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Identifying new patient subtypes and endpoints for COPD
Timepoint [1] 0 0
3 years

Eligibility
Key inclusion criteria
Inclusion criteria:

- COPD Subjects

- A COPD subject will be eligible for inclusion in this study only if all of the
following criteria apply:

- Male or female subjects, aged 40-75 years inclusive

- A baseline (post-bronchodilator) FEV1 <80% of predicted normal and a baseline
(post-bronchodilator) FEV1/FVC ratio 70%

- Current or ex-smokers with a smoking history of at least 10 pack-years (number of pack
years = (number of cigarettes per day / 20) x number of years smoked e.g., 20
cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).

- A signed and dated written informed consent is obtained prior to participation

- Able to comply with the requirements of the protocol and be available for study visits
over 3 years

Control Subjects - Current/Ex Smokers

- A control subject will be eligible for inclusion in this study only if all of the
following criteria apply:

- Male or female subjects, aged 40-75 years inclusive, who are free from significant
disease as determined by history, physical examination and screening investigations

- Baseline (post-bronchodilator) FEV1 >85% of predicted normal. FEV1/FVC ratio >70%

- Current or ex-smokers with a smoking history of at least 10 pack-years (number of pack
years = (number of cigarettes per day / 20) x number of years smoked e.g., 20
cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).

- A signed and dated written informed consent is obtained prior to participation.

- Able to comply with the requirements of the protocol and be available for study visits
over 3 years

Control Subjects - Non-smokers

- A non-smoking control subject will be eligible for inclusion in this study only if all
of the following criteria apply:

- Male or female subjects, aged 40-75 years inclusive, who are free from significant
disease as determined by history, physical examination and screening investigations

- Baseline (post-bronchodilator) FEV1 >85% of predicted normal. FEV1/FVC ratio >70%

- Non-smokers with a smoking history of < 1 pack-year (number of pack years = (number of
cigarettes per day / 20) x number of years smoked).

- A signed and dated written informed consent is obtained prior to participation.

- Able to comply with the requirements of the protocol and be available for study visits
over 3 years
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
COPD Subjects

- A COPD subject will not be eligible for inclusion in this study if any of the
following criteria apply:

- Known respiratory disorders, or disorders identified at screening/visit 1 (including
identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis,
tuberculosis, lung fibrosis, cystic fibrosis)

- Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid
arthritis and Lupus)

- Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)

- Having undergone lung surgery (e.g. lung reduction, lung transplant)

- Have cancer or have had cancer in the 5 years prior to study entry

- Serious, uncontrolled disease (including serious psychological disorders) likely to
interfere with the study or impact on subject safety

- Is enrolled in a long term blinded drug study (subjects in open label studies may be
considered and subjects in short blinded studies (approx less than 12 weeks may be
considered following consultation with sponsor) or a study where there is significant
radiation exposure (e.g.: CT scans)

- Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse

- Have received a blood transfusion in the 4 weeks prior to study start

- Has experienced a moderate or severe exacerbation (requiring oral corticosteroid,
antibiotics or hospitalisation) within the last 4 weeks. All courses of oral
corticosteroids and antibiotics must be completed at least 2 weeks before study start

- Is on long term oral corticosteroids (long term is considered use for more than 3
consecutive months)

- Unable to walk

- Subject is a participating investigator, sub-investigator, study co-ordinator, or
employee of a participating investigator, or is an immediate family member of the
aforementioned.

Control Subjects

- A control subject will not be eligible for inclusion in this study if any of the
following criteria apply:

- Known respiratory disorders, or disorders identified at screening/visit 1 including
identification on the first CT scan (e.g.: COPD, asthma, lung cancer, sarcoidosis,
tuberculosis, lung fibrosis)

- Known history of significant inflammatory disease (eg rheumatoid arthritis and Lupus)

- Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)

- Having undergone lung surgery (e.g. lung reduction, lung transplant)

- Have cancer or have had cancer in the 5 years prior to study entry

- Serious, uncontrolled disease (including serious psychological disorders) likely to
interfere with the study

- Is enrolled in a long term blinded drug study (subjects in open label studies may be
considered and subjects in short blinded studies (approx less than 12 weeks may be
considered following consultation with sponsor) or a study where there is significant
radiation exposure (e.g.: CT scans)

- Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.

- Have received a blood transfusion in the 4 weeks prior to study start

- Is on long term oral corticosteroids (long term is considered use for more than 3
consecutive months)

- Subject is a participating investigator, sub-investigator, study co-ordinator, or
employee of a participating investigator, or is an immediate family member of the
aforementioned.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
Accrual to date
Final
2747
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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United States of America
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Florida
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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New Hampshire
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United States of America
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Pennsylvania
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Rhode Island
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United States of America
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Texas
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United States of America
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Virginia
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Czech Republic
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Praha 8
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Denmark
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Hvidovre
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Netherlands
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Horn
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New Zealand
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Wellington
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Norway
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Bergen
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Slovenia
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Golnik
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Spain
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Palma de Mallorca
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Ukraine
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Donetsk
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Ukraine
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Kiev
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United Kingdom
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Midlothian
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United Kingdom
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Cambridge
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a 3 year longitudinal study to identify novel endpoints and compare these with
standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to
measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression
over time. Control subjects (smokers and never smokers) will be recruited as comparators with
the COPD subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00292552
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00292552