Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00115492

Collaborator

(none)

797

Enrollment

110

Locations

Duration (Months)

7.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by FDA for use in patients with COPD.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Fluticasone Propionate/Salmeterol Combination Product Drug: Salmeterol	Phase 4

Detailed Description

A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50mcg BID with Salmeterol DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Study Design

Study Type:

Interventional

Actual Enrollment :

797 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol Diskus Combination Product 250/50mcg BID With Salmeterol Diskus 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Rate of moderate/severe exacerbations over a 52 week treatment period []

Secondary Outcome Measures

The time until the first moderate/severe exacerbation; the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Diagnosis of COPD.
Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
History of at least 1 COPD exacerbation in the 12 months prior to screening.
Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

Exclusion criteria:

Diagnosis of asthma.
Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
Lung resection surgery within 1 year of screening.
Abnormal and clinically significant ECG findings at screening.
Other inclusion and exclusion criteria will be evaluated at the first study visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Jasper	Alabama	United States	35501
2	GSK Investigational Site	Mobile	Alabama	United States	36608
3	GSK Investigational Site	Glendale	Arizona	United States	85306
4	GSK Investigational Site	Phoenix	Arizona	United States	85013
5	GSK Investigational Site	Berkeley	California	United States	94705
6	GSK Investigational Site	Fullerton	California	United States	92835
7	GSK Investigational Site	Riverside	California	United States	92506
8	GSK Investigational Site	Sacramento	California	United States	95825
9	GSK Investigational Site	San Diego	California	United States	92123
10	GSK Investigational Site	Vista	California	United States	92084
11	GSK Investigational Site	Fort Collins	Colorado	United States	80528
12	GSK Investigational Site	Stamford	Connecticut	United States	06902
13	GSK Investigational Site	Atlantis	Florida	United States	33462
14	GSK Investigational Site	Clear Water	Florida	United States	33756
15	GSK Investigational Site	Deland	Florida	United States	32720
16	GSK Investigational Site	Fort Lauderdale	Florida	United States	33316
17	GSK Investigational Site	Pensacola	Florida	United States	32504
18	GSK Investigational Site	Sarasota	Florida	United States	34239
19	GSK Investigational Site	Tamarac	Florida	United States	33321
20	GSK Investigational Site	Atlanta	Georgia	United States	30342
21	GSK Investigational Site	Woodstock	Georgia	United States	30189
22	GSK Investigational Site	Springfield	Illinois	United States	62702
23	GSK Investigational Site	Elkhart	Indiana	United States	46154
24	GSK Investigational Site	Evansville	Indiana	United States	47710
25	GSK Investigational Site	Evansville	Indiana	United States	47714
26	GSK Investigational Site	Indianapolis	Indiana	United States	46208
27	GSK Investigational Site	South Bend	Indiana	United States	46617
28	GSK Investigational Site	Iowa City	Iowa	United States	52242
29	GSK Investigational Site	Olathe	Kansas	United States	66061
30	GSK Investigational Site	Madisonville	Kentucky	United States	42431
31	GSK Investigational Site	Lafayette	Louisiana	United States	70503
32	GSK Investigational Site	New Orleans	Louisiana	United States	70112
33	GSK Investigational Site	Shreveport	Louisiana	United States	71103
34	GSK Investigational Site	Sunset	Louisiana	United States	70584
35	GSK Investigational Site	Auburn	Maine	United States	04210
36	GSK Investigational Site	Baltimore	Maryland	United States	21201
37	GSK Investigational Site	Boston	Massachusetts	United States	02135
38	GSK Investigational Site	St. Joseph	Michigan	United States	49085
39	GSK Investigational Site	Minneapolis	Minnesota	United States	55407
40	GSK Investigational Site	Chesterfield	Missouri	United States	63017
41	GSK Investigational Site	Jefferson City	Missouri	United States	65101
42	GSK Investigational Site	St. Charles	Missouri	United States	63301
43	GSK Investigational Site	St. Louis	Missouri	United States	63110
44	GSK Investigational Site	Billings	Montana	United States	59102
45	GSK Investigational Site	Butte	Montana	United States	59701
46	GSK Investigational Site	Omaha	Nebraska	United States	68124
47	GSK Investigational Site	Omaha	Nebraska	United States	68131
48	GSK Investigational Site	Absecon	New Jersey	United States	08201
49	GSK Investigational Site	Albany	New York	United States	12205
50	GSK Investigational Site	Bayshore	New York	United States	11706
51	GSK Investigational Site	Ithaca	New York	United States	14850
52	GSK Investigational Site	Larchmont	New York	United States	10538
53	GSK Investigational Site	New York	New York	United States	10016
54	GSK Investigational Site	Chapel Hill	North Carolina	United States	27599
55	GSK Investigational Site	Charlotte	North Carolina	United States	28207
56	GSK Investigational Site	Elizabeth City	North Carolina	United States	27909
57	GSK Investigational Site	High Point	North Carolina	United States	27262
58	GSK Investigational Site	Raleigh	North Carolina	United States	27612
59	GSK Investigational Site	Winston-Salem	North Carolina	United States	27157
60	GSK Investigational Site	Canton	Ohio	United States	44718
61	GSK Investigational Site	Chardon	Ohio	United States	44024
62	GSK Investigational Site	Mogadore	Ohio	United States	44260
63	GSK Investigational Site	Lake Oswego	Oregon	United States	97035
64	GSK Investigational Site	Erie	Pennsylvania	United States	16508
65	GSK Investigational Site	Hershey	Pennsylvania	United States	17033
66	GSK Investigational Site	McKeesport	Pennsylvania	United States	15132
67	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15025
68	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15243
69	GSK Investigational Site	East Providence	Rhode Island	United States	02914
70	GSK Investigational Site	Providence	Rhode Island	United States	2909
71	GSK Investigational Site	Gaffney	South Carolina	United States	29340
72	GSK Investigational Site	Greer	South Carolina	United States	29651
73	GSK Investigational Site	Simpsonville	South Carolina	United States	29681
74	GSK Investigational Site	Spartanburg	South Carolina	United States	29303
75	GSK Investigational Site	Bristol	Tennessee	United States	37620
76	GSK Investigational Site	Chattanooga	Tennessee	United States	37403
77	GSK Investigational Site	Johnson City	Tennessee	United States	37601
78	GSK Investigational Site	Kingsport	Tennessee	United States	37660
79	GSK Investigational Site	Dallas	Texas	United States	75390-9016
80	GSK Investigational Site	Houston	Texas	United States	77074
81	GSK Investigational Site	New Braunfels	Texas	United States	78130
82	GSK Investigational Site	San Antonio	Texas	United States	78217
83	GSK Investigational Site	San Antonio	Texas	United States	78229
84	GSK Investigational Site	San Marcos	Texas	United States	78666
85	GSK Investigational Site	Abingdon	Virginia	United States	24210
86	GSK Investigational Site	Lynchburg	Virginia	United States	24501
87	GSK Investigational Site	Newport News	Virginia	United States	23606
88	GSK Investigational Site	Richmond	Virginia	United States	23225
89	GSK Investigational Site	Bellingham	Washington	United States	98226
90	GSK Investigational Site	Gig Harbor	Washington	United States	98335
91	GSK Investigational Site	Kirkland	Washington	United States	98034
92	GSK Investigational Site	Spokane	Washington	United States	99204
93	GSK Investigational Site	Morgantown	West Virginia	United States	26505
94	GSK Investigational Site	La Crosse	Wisconsin	United States	54601
95	GSK Investigational Site	Milwaukee	Wisconsin	United States	53209
96	GSK Investigational Site	Vancouver	British Columbia	Canada	V5Z 3J5
97	GSK Investigational Site	Winnipeg	Manitoba	Canada	R2K 3S8
98	GSK Investigational Site	Saint John	New Brunswick	Canada	E2M 3W5
99	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador	Canada	A0G 1G0
100	GSK Investigational Site	Holyrood	Newfoundland and Labrador	Canada	A0A 2R0
101	GSK Investigational Site	Grimsby	Ontario	Canada	L3M 1P3
102	GSK Investigational Site	London	Ontario	Canada	N6C 4Y7
103	GSK Investigational Site	Thunder Bay	Ontario	Canada	P7A 4V7
104	GSK Investigational Site	Bonaventure	Quebec	Canada	G0C 1E0
105	GSK Investigational Site	Chandler	Quebec	Canada	G0C 1K0
106	GSK Investigational Site	Charlesbourg	Quebec	Canada	G1G 4A2
107	GSK Investigational Site	Gatineau	Quebec	Canada	J8Y 6S8
108	GSK Investigational Site	Saint Leonard	Quebec	Canada	H1S 3A9
109	GSK Investigational Site	Sherbrooke	Quebec	Canada	J1H 1Z1
110	GSK Investigational Site	Trois Rivieres	Quebec	Canada	G8T 7A1