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A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT00784550

Last Updated: 2016-11-23

Study Results

Results available

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

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD.

SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG.

ADVAIR DISKUS® are registered trademarks of the GSK group of companies.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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Spirometry COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ADVAIR DISKUS® inhlaer Plus SPIRIVA® HANDIHALER® inhaler

Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID Plus Tiotropium Bromide 18 mcg QD

Group Type EXPERIMENTAL

Fluticasone Propionate/Salmeterol

Intervention Type DRUG

Inhaled corticosteroid plus long-acting bronchodilator

SPIRIVA® HANDIHALER® inhaler

Tiotropium Bromide 18mcg QD plus Placebo DISKUS BID

Group Type ACTIVE_COMPARATOR

Tiotropium Bromide

Intervention Type DRUG

Long-acting muscarinic antagonist

Interventions

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Tiotropium Bromide

Long-acting muscarinic antagonist

Intervention Type DRUG

Fluticasone Propionate/Salmeterol

Inhaled corticosteroid plus long-acting bronchodilator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* COPD diagnosis
* At least 10 pack year smoking history
* Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of predicted normal
* An FEV1/FVC ratio of less than or equal to 0.70

Exclusion Criteria

* Current diagnosis of asthma
* Other respiratory disorder other than COPD
* Abnormal and clinical significant ECG
* Chest x-ray clinically significant abnormality not believed to be due to COPD
* Body Mass Index of greater than or equal to 40/kg/m2
* Use of Long Term Oxygen Therapy
* Lung resection surgery
* Women pregnant or lactating at Visit 1
* Previously diagnosed cancer unless in complete remission for 2 years at Visit 1
Minimum Eligible Age

40 Years

Maximum Eligible Age

99 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

Riverside, California, United States

Site Status

GSK Investigational Site

Fort Collins, Colorado, United States

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GSK Investigational Site

Clearwater, Florida, United States

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GSK Investigational Site

DeLand, Florida, United States

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GSK Investigational Site

Naranja, Florida, United States

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GSK Investigational Site

Coeur d'Alene, Idaho, United States

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GSK Investigational Site

Gillespie, Illinois, United States

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GSK Investigational Site

Elkhart, Indiana, United States

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GSK Investigational Site

Olathe, Kansas, United States

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Louisville, Kentucky, United States

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GSK Investigational Site

Shreveport, Louisiana, United States

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GSK Investigational Site

Sunset, Louisiana, United States

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GSK Investigational Site

Saint Charles, Missouri, United States

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GSK Investigational Site

Omaha, Nebraska, United States

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GSK Investigational Site

Albany, New York, United States

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GSK Investigational Site

Elizabeth City, North Carolina, United States

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GSK Investigational Site

Mooresville, North Carolina, United States

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GSK Investigational Site

Statesville, North Carolina, United States

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Cincinnati, Ohio, United States

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GSK Investigational Site

Cleveland, Ohio, United States

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GSK Investigational Site

Erie, Pennsylvania, United States

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GSK Investigational Site

Cumberland, Rhode Island, United States

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GSK Investigational Site

Charleston, South Carolina, United States

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GSK Investigational Site

Gaffney, South Carolina, United States

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GSK Investigational Site

Greenville, South Carolina, United States

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GSK Investigational Site

Spartanburg, South Carolina, United States

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GSK Investigational Site

Union, South Carolina, United States

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GSK Investigational Site

Milan, Tennessee, United States

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GSK Investigational Site

Boerne, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Plano, Texas, United States

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GSK Investigational Site

West Jordan, Utah, United States

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GSK Investigational Site

Newport News, Virginia, United States

Site Status

GSK Investigational Site

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Hanania NA, Crater GD, Morris AN, Emmett AH, O'Dell DM, Niewoehner DE. Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. Respir Med. 2012 Jan;106(1):91-101. doi: 10.1016/j.rmed.2011.09.002. Epub 2011 Oct 29.

Reference Type BACKGROUND
PMID: 22040533 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Dataset Specification

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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111114

Identifier Type: -

Identifier Source: org_study_id