Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints

Pulmonary Disease, Chronic Obstructive Clinical Trial

— ECLIPSE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292552
• Other study ID #: SCO104960
• Status: Completed
• Phase: N/A
• First received: February 14, 2006
• Last updated: March 21, 2017
• Start date: December 2005
• Est. completion date: February 2010

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2747
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Novel endpoint determination
Novel endpoint determination

Locations

Country	Name	City	State
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Sofia
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Vancouver	British Columbia
Czech Republic	GSK Investigational Site	Praha 8
Denmark	GSK Investigational Site	Hvidovre
Netherlands	GSK Investigational Site	Horn
New Zealand	GSK Investigational Site	Wellington
Norway	GSK Investigational Site	Bergen
Slovenia	GSK Investigational Site	Golnik
Spain	GSK Investigational Site	Palma de Mallorca
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Kiev
Ukraine	GSK Investigational Site	Kiev
United Kingdom	GSK Investigational Site	Cambridge
United Kingdom	GSK Investigational Site	Edinburgh	Midlothian
United Kingdom	GSK Investigational Site	Liverpool
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Hartford	Connecticut
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Lebanon	New Hampshire
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	New Haven	Connecticut
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Rancho Mirage	California
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rochester	Minnesota
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	St. Charles	Missouri
United States	GSK Investigational Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czech Republic,  Denmark,  Netherlands,  New Zealand,  Norway,  Slovenia,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identifying new patient subtypes and endpoints for COPD		3 years