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

NCT00791518 | Completed Results

• 1 other identifier: 111891
• Study Type: observational
• Target: 1,084
• Locations: 1 country
• Sites: 57

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Spirometry

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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%

  Day 1 of a 1-day study

• Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%

  Day 1 of a 1-day study

• Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%

  Day 1 of a 1-day study

Study Arms (1)

No group

No group

Drug: No intervention

Interventions

No intervention DRUG

No intervention

No group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (57)

GSK Investigational Site

Birmingham, Alabama, 25249, United States

Location

GSK Investigational Site

Tucson, Arizona, 85741, United States

Location

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

National City, California, 91950, United States

Location

GSK Investigational Site

Rancho Mirage, California, 92270, United States

Location

GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

Santa Ana, California, 92704, United States

Location

GSK Investigational Site

Walnut Creek, California, 94598, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80907, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80909, United States

Location

GSK Investigational Site

Stamford, Connecticut, 06902, United States

Location

GSK Investigational Site

Cocoa, Florida, 32927, United States

Location

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

Largo, Florida, 33770, United States

Location

GSK Investigational Site

Miami, Florida, 33183, United States

Location

GSK Investigational Site

Miami, Florida, 33186, United States

Location

GSK Investigational Site

Naranja, Florida, 33032, United States

Location

GSK Investigational Site

South Miami, Florida, 33143, United States

Location

GSK Investigational Site

Tamarac, Florida, 33321, United States

Location

GSK Investigational Site

Tampa, Florida, 33613, United States

Location

GSK Investigational Site

Winter Park, Florida, 32789, United States

Location

GSK Investigational Site

Evansville, Indiana, 47711, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46229, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70115, United States

Location

GSK Investigational Site

Sunset, Louisiana, 70584, United States

Location

GSK Investigational Site

Biddeford, Maine, 04005, United States

Location

GSK Investigational Site

Rochester, Minnesota, 55904, United States

Location

GSK Investigational Site

Albany, New York, 12205, United States

Location

GSK Investigational Site

Mooresville, North Carolina, 28117, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27609, United States

Location

GSK Investigational Site

Salisbury, North Carolina, 28144, United States

Location

GSK Investigational Site

Wilmington, North Carolina, 28401, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Canton, Ohio, 44718, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45231, United States

Location

GSK Investigational Site

Dayton, Ohio, 45439, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73120, United States

Location

GSK Investigational Site

Portland, Oregon, 97213, United States

Location

GSK Investigational Site

Clairton, Pennsylvania, 15205, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15243, United States

Location

GSK Investigational Site

Anderson, South Carolina, 29621, United States

Location

GSK Investigational Site

Easley, South Carolina, 29650, United States

Location

GSK Investigational Site

Gaffney, South Carolina, 29340, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Union, South Carolina, 29379, United States

Location

GSK Investigational Site

Johnson City, Tennessee, 37601, United States

Location

GSK Investigational Site

Milan, Tennessee, 38358, United States

Location

GSK Investigational Site

New Tazewell, Tennessee, 37824-1409, United States

Location

GSK Investigational Site

Boerne, Texas, 78006, United States

Location

GSK Investigational Site

Houston, Texas, 77054, United States

Location

GSK Investigational Site

Killeen, Texas, 76542, United States

Location

GSK Investigational Site

Plano, Texas, 75024, United States

Location

GSK Investigational Site

Waco, Texas, 76712, United States

Location

GSK Investigational Site

Wichita Falls, Texas, 76309, United States

Location

Related Publications (1)

• 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.

  PMID: 20886200 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 30, 2014
• Results First Posted: April 22, 2010

Record last verified: 2012-10

Locations

US (57)