MedDataX Logo

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

NCT ID: NCT00791518

Last Updated: 2014-07-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1084 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251

NCT02449018

Chronic Obstructive Pulmonary Disease, COPD
COMPLETED PHASE2

Study in Patients' With Persistent Asthma and Chronic Obstructive Pulmonary Disease

NCT02419872

Asthma Chronic Obstructive Pulmonary Disease
COMPLETED

Safety and Tolerability of Multiple Inhaled NVA237 Doses in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT00545311

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE1

A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00856193

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE2

Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT00676052

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No group

No group

No intervention

Intervention Type DRUG

No intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

No intervention

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Tucson, Arizona, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

National City, California, United States

Site Status

GSK Investigational Site

Rancho Mirage, California, United States

Site Status

GSK Investigational Site

Riverside, California, United States

Site Status

GSK Investigational Site

Santa Ana, California, United States

Site Status

GSK Investigational Site

Walnut Creek, California, United States

Site Status

GSK Investigational Site

Colorado Springs, Colorado, United States

Site Status

GSK Investigational Site

Colorado Springs, Colorado, United States

Site Status

GSK Investigational Site

Stamford, Connecticut, United States

Site Status

GSK Investigational Site

Cocoa, Florida, United States

Site Status

GSK Investigational Site

DeLand, Florida, United States

Site Status

GSK Investigational Site

Largo, Florida, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Naranja, Florida, United States

Site Status

GSK Investigational Site

South Miami, Florida, United States

Site Status

GSK Investigational Site

Tamarac, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Winter Park, Florida, United States

Site Status

GSK Investigational Site

Evansville, Indiana, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

New Orleans, Louisiana, United States

Site Status

GSK Investigational Site

Sunset, Louisiana, United States

Site Status

GSK Investigational Site

Biddeford, Maine, United States

Site Status

GSK Investigational Site

Rochester, Minnesota, United States

Site Status

GSK Investigational Site

Albany, New York, United States

Site Status

GSK Investigational Site

Mooresville, North Carolina, United States

Site Status

GSK Investigational Site

Raleigh, North Carolina, United States

Site Status

GSK Investigational Site

Salisbury, North Carolina, United States

Site Status

GSK Investigational Site

Wilmington, North Carolina, United States

Site Status

GSK Investigational Site

Winston-Salem, North Carolina, United States

Site Status

GSK Investigational Site

Canton, Ohio, United States

Site Status

GSK Investigational Site

Cincinnati, Ohio, United States

Site Status

GSK Investigational Site

Dayton, Ohio, United States

Site Status

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

GSK Investigational Site

Clairton, Pennsylvania, United States

Site Status

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

GSK Investigational Site

Anderson, South Carolina, United States

Site Status

GSK Investigational Site

Easley, South Carolina, United States

Site Status

GSK Investigational Site

Gaffney, South Carolina, United States

Site Status

GSK Investigational Site

Greenville, South Carolina, United States

Site Status

GSK Investigational Site

Mt. Pleasant, South Carolina, United States

Site Status

GSK Investigational Site

Spartanburg, South Carolina, United States

Site Status

GSK Investigational Site

Union, South Carolina, United States

Site Status

GSK Investigational Site

Johnson City, Tennessee, United States

Site Status

GSK Investigational Site

Milan, Tennessee, United States

Site Status

GSK Investigational Site

New Tazewell, Tennessee, United States

Site Status

GSK Investigational Site

Boerne, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Killeen, Texas, United States

Site Status

GSK Investigational Site

Plano, Texas, United States

Site Status

GSK Investigational Site

Waco, Texas, United States

Site Status

GSK Investigational Site

Wichita Falls, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20886200 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

111891

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
NCT06154837 RECRUITING PHASE1
Study of GSK961081 in Healthy Volunteer Subjects
NCT00887406 COMPLETED PHASE1
A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
NCT00559910 COMPLETED PHASE2
Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary Disease
NCT00984659 COMPLETED PHASE4
A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01372410 COMPLETED PHASE2
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT01001494 COMPLETED PHASE3
Investigation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of Oral Danirixin in Symptomatic COPD Subjects With Mild to Moderate Airflow Limitation at Risk for Exacerbations
NCT02130193 COMPLETED PHASE2
A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
NCT00363896 COMPLETED PHASE3
Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease
NCT01391559 COMPLETED NA
Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
NCT00783406 COMPLETED PHASE2
Symbicort in Chronic Obstruktive Pulmonary Disease
NCT00612976 COMPLETED
Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)
NCT01045161 COMPLETED PHASE3
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
NCT01005901 COMPLETED PHASE3
Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01119950 COMPLETED PHASE2
Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00690482 COMPLETED PHASE2
Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium
NCT00501852 COMPLETED PHASE2
Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993 in Healthy Volunteers
NCT02743013 COMPLETED PHASE1
Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo
NCT01049360 COMPLETED PHASE2
Pharmaceutical Care for Chronic Obstructive Pulmonary Disease (COPD) Study.
NCT01260389 COMPLETED NA
Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
NCT01572792 COMPLETED PHASE3
Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD
NCT00749411 COMPLETED PHASE2
NVA237 BID Versus Placebo Twelve-week Efficacy Study
NCT01715298 COMPLETED PHASE3
Symbicort in Chronic Obstructive Pulmonary Disease
NCT00611520 COMPLETED
Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD
NCT01387230 COMPLETED PHASE3
Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.
NCT01120093 COMPLETED PHASE2