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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Tiotropium Bromide Drug: FLuticasone Propionate/Salmeterol	Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Tiotropium bromide

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint [ Time Frame: Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant) ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint [ Time Frame: Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant) ] [ Designated as safety issue: No ]
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.
Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint [ Time Frame: Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant) ] [ Designated as safety issue: No ]
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.
Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint [ Time Frame: Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant) ] [ Designated as safety issue: No ]
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).
Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint [ Time Frame: Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant) ] [ Designated as safety issue: No ]
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.
Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint [ Time Frame: 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) ] [ Designated as safety issue: No ]
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.

Enrollment:	342
Study Start Date:	December 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ADVAIR DISKUS Plus SPIRIVA HANDIHALER 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 Tiotropium Bromide 18mcg QD plus Placebo DISKUS BID	Drug: Tiotropium Bromide Long-acting muscarinic antagonist

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784550

Show 35 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Oct 29.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00784550 History of Changes
Other Study ID Numbers:	111114
Study First Received:	October 31, 2008
Results First Received:	November 18, 2010
Last Updated:	September 13, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Spirometry
COPD

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Bromides
Salmeterol
Fluticasone
Tiotropium
Fluticasone, salmeterol drug combination
Anticonvulsants
Central Nervous System Agents

Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013

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 (ADC111114)