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Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT00984659

Last Updated: 2018-08-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-29

Study Completion Date

2010-07-01

Brief Summary

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The purpose of this study is to evaluate a new questionnaire to capture the patient experience of COPD. The information collected will be used to validate the Shortness of Breath with Daily Activities Questionnaire.

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Detailed Description

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Dyspnea, referred to by patients as "shortness of breath" or "breathlessness," is frequently associated with decreases in functional status, quality of life, and disabilities. Currently available questionnaires do not specifically address the shortness of breath component of COPD. The development of a patient reported outcome questionnaire that will specifically assess Shortness of Breath with Daily Activities (SOBDA) in patients with COPD is needed.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FSC

Fluticasone propionate/salmeterol combination product 250/50mcg DISKUS twice a day

Group Type EXPERIMENTAL

Fluticasone propionate/salmeterol combination product

Intervention Type DRUG

Fluticasone propionate/salmeterol combination product 250/50mcg DISKUS twice a day for 8 weeks

SAL

Salmeterol 50mcg DISKUS twice a day

Group Type EXPERIMENTAL

Salmeterol

Intervention Type DRUG

Salmeterol 50mcg DISKUS twice a day for 8 weeks

Placebo

Placebo DISKUS twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo DISKUS twice a day for 8 weeks

Interventions

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Fluticasone propionate/salmeterol combination product

Fluticasone propionate/salmeterol combination product 250/50mcg DISKUS twice a day for 8 weeks

Intervention Type DRUG

Salmeterol

Salmeterol 50mcg DISKUS twice a day for 8 weeks

Intervention Type DRUG

Placebo

Placebo DISKUS twice a day for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults ≥ 40 years of age
* Established clinical history of COPD by ATS/ERS definition
* Former or current smoker \> 10 pack years
* Evidence of dyspnea

Exclusion Criteria

* Has a respiratory disorder other than COPD
* Cancer not in complete clinical remission
* Clinically significant cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine, or hematological abnormalities that are uncontrolled
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Jasper, Alabama, United States

Site Status

GSK Investigational Site

Mobile, Alabama, United States

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Los Angeles, California, United States

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Riverside, California, United States

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Wheat Ridge, Colorado, United States

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Stamford, Connecticut, United States

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Tamarac, Florida, United States

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Decatur, Georgia, United States

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Lawrenceville, Georgia, United States

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Evansville, Indiana, United States

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Evansville, Indiana, United States

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South Bend, Indiana, United States

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Madisonville, Kentucky, United States

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New Orleans, Louisiana, United States

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Sunset, Louisiana, United States

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St Louis, Missouri, United States

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Summit, New Jersey, United States

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Charlotte, North Carolina, United States

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Elizabeth City, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Lake Oswego, Oregon, United States

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Portland, Oregon, United States

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Erie, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Chester, South Carolina, United States

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Clinton, South Carolina, United States

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Easley, South Carolina, United States

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Gaffney, South Carolina, United States

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Greenwood, South Carolina, United States

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GSK Investigational Site

Seneca, South Carolina, United States

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GSK Investigational Site

Spartanburg, South Carolina, United States

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GSK Investigational Site

Johnson City, Tennessee, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

New Braunfels, Texas, United States

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GSK Investigational Site

Abingdon, Virginia, United States

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GSK Investigational Site

Richmond, Virginia, United States

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GSK Investigational Site

Spokane, Washington, United States

Site Status

Countries

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United States

References

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Watkins ML, Wilcox TK, Tabberer M, Brooks JM, Donohue JF, Anzueto A, Chen WH, Crim C. Shortness of Breath with Daily Activities questionnaire: validation and responder thresholds in patients with chronic obstructive pulmonary disease. BMJ Open. 2013 Oct 22;3(10):e003048. doi: 10.1136/bmjopen-2013-003048.

Reference Type DERIVED
PMID: 24154513 (View on PubMed)

Study Documents

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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112989

Identifier Type: -

Identifier Source: org_study_id

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