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). (ADC111114)

A Randomized, Double-Blind, Parallel-Group, 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 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Fluticasone Propionate/Salmeterol; Drug: Tiotropium Bromide

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Riverside, California, United States, 92506
      • GSK Investigational Site
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • GSK Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33756
      • GSK Investigational Site
    • Deland, Florida, United States, 32720
      • GSK Investigational Site
    • Naranja, Florida, United States, 33032
      • GSK Investigational Site
  • Idaho
    • Coeur D'Alene, Idaho, United States, 83814
      • GSK Investigational Site
  • Illinois
    • Gillespie, Illinois, United States, 62033
      • GSK Investigational Site
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • GSK Investigational Site
  • Kansas
    • Olathe, Kansas, United States, 66061
      • GSK Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • GSK Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • GSK Investigational Site
    • Sunset, Louisiana, United States, 70584
      • GSK Investigational Site
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • GSK Investigational Site
  • New York
    • Albany, New York, United States, 12205
      • GSK Investigational Site
  • North Carolina
    • Elizabeth City, North Carolina, United States, 27909
      • GSK Investigational Site
    • Mooresville, North Carolina, United States, 28117
      • GSK Investigational Site
    • Statesville, North Carolina, United States, 28625
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44122
      • GSK Investigational Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16508
      • GSK Investigational Site
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406-7108
      • GSK Investigational Site
    • Gaffney, South Carolina, United States, 29340
      • GSK Investigational Site
    • Greenville, South Carolina, United States, 29615
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
    • Union, South Carolina, United States, 29379
      • GSK Investigational Site
  • Tennessee
    • Milan, Tennessee, United States, 38358
      • GSK Investigational Site
  • Texas
    • Boerne, Texas, United States, 78006
      • GSK Investigational Site
    • Houston, Texas, United States, 77030
      • GSK Investigational Site
    • Houston, Texas, United States, 77054
      • GSK Investigational Site
    • Plano, Texas, United States, 75024
      • GSK Investigational Site
  • Utah
    • West Jordan, Utah, United States, 84088
      • GSK Investigational Site
  • Virginia
    • Newport News, Virginia, United States, 23606
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23229
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADVAIR DISKUS® inhlaer Plus SPIRIVA® HANDIHALER® inhaler; Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID Plus Tiotropium Bromide 18 mcg QD	Drug: Fluticasone Propionate/Salmeterol; Inhaled corticosteroid plus long-acting bronchodilator
Active Comparator: SPIRIVA® HANDIHALER® inhaler; Tiotropium Bromide 18mcg QD plus Placebo DISKUS BID	Drug: Tiotropium Bromide; Long-acting muscarinic antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint	Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.	Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint	Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.	Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)
Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint	Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FVC fore each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration.	Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)
Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint	Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FVC for each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration (FVC).	Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)
Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint	Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose IC for each participant) value minus the baseline value. IC is defined as the amount of air that can be inhaled after a normal expiration. IC is a measure of pulmonary function.	Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)
Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint	The CRQ-SAS measures 4 domains of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately.	Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: October 31, 2008
• First Submitted That Met QC Criteria: November 3, 2008
• First Posted (Estimate): November 4, 2008

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: COPD; Spirometry
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Xhance; Salmeterol Xinafoate; Tiotropium Bromide; Bromides
• Other Study ID Numbers: 111114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Study Protocol
   Information identifier: 111114
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Annotated Case Report Form
   Information identifier: 111114
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Clinical Study Report
   Information identifier: 111114
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 111114
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 111114
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: 111114
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Informed Consent Form
   Information identifier: 111114
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register