Pulmonary Disease, Chronic ObstructiveLABDNCT00791518

Evaluation of Lung Function and Symptoms in Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 57 sites in United States.

Completed

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

Trial summary

A multicenter study to evaluate lung function and symptoms in subjects with COPD who have been on regular use of only one long-acting bronchodilator. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
How many people: 1,084 participants
Where: 57 sitesUnited States
Study dates: Dec 2008to May 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 with diagnosed COPD who are on only one long acting bronchodilator medication to control their COPD symptoms.

Who may be able to join

Cigarette smoking history-Current or ex-smokers (defined as stopped smoking for at least three months prior to the study visit)
Established history of COPD as diagnosed by a physician
Regular use (prescribed for use every day) of only one long-acting bronchodilator greater than or equal to one month before the study visit
Ability to read, comprehend, and record information in the English language

Who cannot join

Currently active asthma (receiving asthma therapy and or having asthma symptoms)
Use of ipratropium/albuterol combination products greater than three times per day, use of inhaled corticosteroids, use of inhaled corticosteroid/long-acting beta-agonist combinations, theophylline preparations, or oral beta agonists within 3 months prior to the study visit
Previous lung surgery
Other respiratory disorders other than COPD
Current alcohol, illegal drug, or solvent abuse
Females with a positive urine pregnancy test at the study visit

Trial locations and contacts

57 sites in 1 country.

City, postcode or hospital

57 sites in 1 country

United States57 sites

GSK Investigational Site
Albany, New York, 12205
GSK Investigational Site
Anderson, South Carolina, 29621
GSK Investigational Site
Biddeford, Maine, 04005
GSK Investigational Site
Birmingham, Alabama, 25249
GSK Investigational Site
Boerne, Texas, 78006
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Clairton, Pennsylvania, 15205
GSK Investigational Site
Cocoa, Florida, 32927
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Colorado Springs, Colorado, 80909
GSK Investigational Site
Dayton, Ohio, 45439
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Easley, South Carolina, 29650
GSK Investigational Site
Evansville, Indiana, 47711
GSK Investigational Site
Gaffney, South Carolina, 29340
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Houston, Texas, 77054
GSK Investigational Site
Indianapolis, Indiana, 46229
GSK Investigational Site
Johnson City, Tennessee, 37601
GSK Investigational Site
Killeen, Texas, 76542
GSK Investigational Site
Largo, Florida, 33770
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Miami, Florida, 33183
GSK Investigational Site
Miami, Florida, 33186
GSK Investigational Site
Milan, Tennessee, 38358
GSK Investigational Site
Mooresville, North Carolina, 28117
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
Naranja, Florida, 33032
GSK Investigational Site
National City, California, 91950
GSK Investigational Site
New Orleans, Louisiana, 70115
GSK Investigational Site
New Tazewell, Tennessee, 37824-1409
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243
GSK Investigational Site
Plano, Texas, 75024
GSK Investigational Site
Portland, Oregon, 97213
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Rancho Mirage, California, 92270
GSK Investigational Site
Riverside, California, 92506
GSK Investigational Site
Rochester, Minnesota, 55904
GSK Investigational Site
Salisbury, North Carolina, 28144
GSK Investigational Site
Santa Ana, California, 92704
GSK Investigational Site
South Miami, Florida, 33143
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Stamford, Connecticut, 06902
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Tamarac, Florida, 33321
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Tucson, Arizona, 85741
GSK Investigational Site
Union, South Carolina, 29379
GSK Investigational Site
Waco, Texas, 76712
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
Wichita Falls, Texas, 76309
GSK Investigational Site
Wilmington, North Carolina, 28401
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: An Evaluation of Lung Function and Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy

A multicenter study to evaluate lung function and symptoms in subjects with COPD who have been on regular use of only one long-acting bronchodilator.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: No intervention
Keywords: Chronic Obstructive Pulmonary Disease (COPD), Spirometry
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.

No interventionDrug
No intervention

Study groups in NCT00791518
Study group	Role	What they receive
No group		No group Receives: Drug: No intervention

What is being measured

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

Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal
The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.
Measured: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)

Secondary outcomes (11)

Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal
The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) <50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.
Measured: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios
The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).
Measured: Day 1 of a 1-day study
Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%
The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).
Measured: Day 1 of a 1-day study
Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%
The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).
Measured: Day 1 of a 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%
The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.
Measured: Day 1 of a 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%
The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.
Measured: Day 1 of 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%
The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.
Measured: Day 1 of 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%
The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.
Measured: Day 1 of 1-day study
Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%
The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.
Measured: Day 1 of a 1-day study
Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%
The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.
Measured: Day 1 of a 1-day study
Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups
The number of participants with the indicated affected medical conditions were counted.
Measured: Day 1 of a 1-day study

Timeline

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

Dec 2008May 2009

First posted14 Nov 2008 (estimated)
Study startDec 2008
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Prospective
Enrolment: 1,084 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00791518
Sponsor's protocol ID: 111891
Acronym: LABD
Status last verified: Oct 2012
First submitted: 13 Nov 2008
Last updated: 30 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Dransfield MT, Bailey W, Crater G, Emmett A, O'Dell DM, Yawn B. Disease severity and symptoms among patients receiving monotherapy for COPD. Prim Care Respir J. 2011 Mar;20(1):46-53. doi: 10.4104/pcrj.2010.00059.
PubMed 20886200

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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Not yet recruiting
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Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of Lung Function and Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy
ClinicalTrials.gov ID: NCT00791518
Acronym / sponsor ID: LABD / 111891
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease (COPD), Spirometry
Study type: Observational
Recruitment status: Completed
Enrolment: 1,084 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 14 Nov 2008 (estimated)
Results: Posted 22 Apr 2010

Clinical summary

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

A multicenter study to evaluate lung function and symptoms in subjects with COPD who have been on regular use of only one long-acting bronchodilator.

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
No group	–	Drug: No interventionNo group

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with diagnosed COPD who are on only one long acting bronchodilator medication to control their COPD symptoms.

Key inclusion criteria (4 listed)

Cigarette smoking history-Current or ex-smokers (defined as stopped smoking for at least three months prior to the study visit)
Established history of COPD as diagnosed by a physician
Regular use (prescribed for use every day) of only one long-acting bronchodilator greater than or equal to one month before the study visit
Ability to read, comprehend, and record information in the English language

Key exclusion criteria (6 listed)

Currently active asthma (receiving asthma therapy and or having asthma symptoms)
Use of ipratropium/albuterol combination products greater than three times per day, use of inhaled corticosteroids, use of inhaled corticosteroid/long-acting beta-agonist combinations, theophylline preparations, or oral beta agonists within 3 months prior to the study visit
Previous lung surgery
Other respiratory disorders other than COPD
Current alcohol, illegal drug, or solvent abuse

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

Interventions

Intervention	Type	Arms
No interventionNo intervention	Drug	No group

Primary outcome

Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal
Time frame: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.

11 secondary outcomes

Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal
Time frame: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios
Time frame: Day 1 of a 1-day study
Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%
Time frame: Day 1 of a 1-day study
Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%
Time frame: Day 1 of a 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%
Time frame: Day 1 of a 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%
Time frame: Day 1 of 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%
Time frame: Day 1 of 1-day study
Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%
Time frame: Day 1 of 1-day study
Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%
Time frame: Day 1 of a 1-day study
Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%
Time frame: Day 1 of a 1-day study
Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups
Time frame: Day 1 of a 1-day study

Results and safety

Results posted to the registry on 22 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Diagnosed COPD	1,084	991

Primary outcome: Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal

Time frame: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered). Number. Unit: percentage of participants

Measure	Participants With Diagnosed COPD n = 1072
<80% predicted normal	70
>=80% predicted normal	30

Population analysed: All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 of a 1-day study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Diagnosed COPD	0 of 1,084 (0%)	5 of 1,084 (0.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20886200Dransfield MT, Bailey W, Crater G, Emmett A, O'Dell DM, Yawn B. Disease severity and symptoms among patients receiving monotherapy for COPD. Prim Care Respir J. 2011 Mar;20(1):46-53. doi: 10.4104/pcrj.2010.00059.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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
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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.

GSK Clinical Trials study director

GlaxoSmithKline

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

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 57 sites in United States.

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 6 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 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States. 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?

Yes. Results are posted in the registry (first posted 22 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal (time frame: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)). 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 NCT00791518, 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 30 Jul 2014.