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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: Tiotropium Bromide (Drug); FLuticasone Propionate/Salmeterol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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 18mcg (TIOTROPIUM)compared to SPIRIVA HANDIHALER 18mcg (TIOTROPIUM) in patients with COPD.

Clinical Details

Official title: A 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR DISKUS (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint

Secondary outcome:

Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint

Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint

Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint

Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint

Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

GSK Investigational Site, Riverside, California 92506, United States

GSK Investigational Site, Fort Collins, Colorado 80528, United States

GSK Investigational Site, Clearwater, Florida 33756, United States

GSK Investigational Site, Deland, Florida 32720, United States

GSK Investigational Site, Naranja, Florida 33032, United States

GSK Investigational Site, Coeur D'Alene, Idaho 83814, United States

GSK Investigational Site, Gillespie, Illinois 62033, United States

GSK Investigational Site, Elkhart, Indiana 46514, United States

GSK Investigational Site, Olathe, Kansas 66061, United States

GSK Investigational Site, Louisville, Kentucky 40207, United States

GSK Investigational Site, Shreveport, Louisiana 71103, United States

GSK Investigational Site, Sunset, Louisiana 70584, United States

GSK Investigational Site, St. Charles, Missouri 63301, United States

GSK Investigational Site, Omaha, Nebraska 68131, United States

GSK Investigational Site, Albany, New York 12205, United States

GSK Investigational Site, Elizabeth City, North Carolina 27909, United States

GSK Investigational Site, Mooresville, North Carolina 28117, United States

GSK Investigational Site, Statesville, North Carolina 28625, United States

GSK Investigational Site, Cincinnati, Ohio 45231, United States

GSK Investigational Site, Cleveland, Ohio 44122, United States

GSK Investigational Site, Erie, Pennsylvania 16508, United States

GSK Investigational Site, Cumberland, Rhode Island 02864, United States

GSK Investigational Site, Charleston, South Carolina 29406-7108, United States

GSK Investigational Site, Gaffney, South Carolina 29340, United States

GSK Investigational Site, Greenville, South Carolina 29615, United States

GSK Investigational Site, Spartanburg, South Carolina 29303, United States

GSK Investigational Site, Union, South Carolina 29379, United States

GSK Investigational Site, Milan, Tennessee 38358, United States

GSK Investigational Site, Boerne, Texas 78006, United States

GSK Investigational Site, Houston, Texas 77030, United States

GSK Investigational Site, Houston, Texas 77054, United States

GSK Investigational Site, Plano, Texas 75024, United States

GSK Investigational Site, West Jordan, Utah 84088, United States

GSK Investigational Site, Newport News, Virginia 23606, United States

GSK Investigational Site, Richmond, Virginia 23229, United States

Additional Information

Related publications:

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.

Starting date: December 2008
Last updated: September 13, 2012

Page last updated: August 23, 2015

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