A7881013: A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00808288

Collaborator

(none)

405

Enrollment

Locations

Arms

Duration (Months)

5.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive	Drug: PF-00610355 Drug: PF - 00610355 Drug: PF- 00610355 Drug: Placebo Drug: Salmeterol	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

405 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease.

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-00610355	Drug: PF-00610355 oral, inhaled, dry powder, 600ug, OD
Experimental: PF- 00610355	Drug: PF - 00610355 oral, inhaled, dry powder, 300ug, OD
Experimental: PF - 00610355	Drug: PF- 00610355 oral, inhaled, dry powder, 100ug, OD
Placebo Comparator: Placebo	Drug: Placebo oral, inhaled, dry powder, placebo, OD
Active Comparator: Salmeterol	Drug: Salmeterol salmeterol, 50ug, BID

Outcome Measures

Primary Outcome Measures

Change from baseline in trough FEV1 [6 week]

Secondary Outcome Measures

Maximal and mean changes from baseline in heart rate, QTc and plasma potassium [each visit]
Change from baseline in peak FEV1 [0-6 hours /6 weeks]
Change from baseline in trough and peak FEV6, FVC and IC [6 weeks]
Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC) [2 and 4 weeks]
Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS) [2,4,6 weeks]
Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary). [weekly]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%.
Diagnosis of moderate COPD for a minimum of 6 months.
Stable disease for at least 1 month prior to screening

Exclusion Criteria:

More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Fairhope	Alabama	United States	36532
2	Pfizer Investigational Site	San Diego	California	United States	92120
3	Pfizer Investigational Site	Spring Valley	California	United States	91978
4	Pfizer Investigational Site	Wheat Ridge	Colorado	United States	80033
5	Pfizer Investigational Site	Daytona Beach	Florida	United States	32114
6	Pfizer Investigational Site	Ormond Beach	Florida	United States	32174
7	Pfizer Investigational Site	Tampa	Florida	United States	33613
8	Pfizer Investigational Site	Trinity	Florida	United States	34655
9	Pfizer Investigational Site	Austell	Georgia	United States	30106
10	Pfizer Investigational Site	Overland Park	Kansas	United States	66211
11	Pfizer Investigational Site	Overland Park	Kansas	United States	66212
12	Pfizer Investigational Site	Fridley	Minnesota	United States	55432
13	Pfizer Investigational Site	Minneapolis	Minnesota	United States	55407
14	Pfizer Investigational Site	Rochester	Minnesota	United States	55905
15	Pfizer Investigational Site	Saint Louis	Missouri	United States	63141
16	Pfizer Investigational Site	Rochester	New York	United States	14618
17	Pfizer Investigational Site	Charlotte	North Carolina	United States	28207
18	Pfizer Investigational Site	Cincinnati	Ohio	United States	45227
19	Pfizer Investigational Site	Cincinnati	Ohio	United States	45231
20	Pfizer Investigational Site	Cincinnati	Ohio	United States	45242
21	Pfizer Investigational Site	Cincinnati	Ohio	United States	45245
22	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73112
23	Pfizer Investigational Site	Lincoln	Rhode Island	United States	02865
24	Pfizer Investigational Site	Pawtucket	Rhode Island	United States	02860
25	Pfizer Investigational Site	Charleston	South Carolina	United States	29407
26	Pfizer Investigational Site	Charleston	South Carolina	United States	29414
27	Pfizer Investigational Site	Columbia	South Carolina	United States	29204
28	Pfizer Investigational Site	Houston	Texas	United States	77030
29	Pfizer Investigational Site	San Antonio	Texas	United States	78212
30	Pfizer Investigational Site	Morgantown	West Virginia	United States	26505
31	Pfizer Investigational Site	Rosario	Santa Fe	Argentina	2000
32	Pfizer Investigational Site	Buenos Aires		Argentina	1426
33	Pfizer Investigational Site	Buenos Aires		Argentina	C1405BCH
34	Pfizer Investigational Site	Ruse		Bulgaria	7002
35	Pfizer Investigational Site	Sofia		Bulgaria	1431
36	Pfizer Investigational Site	Sofia		Bulgaria	1606
37	Pfizer Investigational Site	Stara Zagora		Bulgaria	6003
38	Pfizer Investigational Site	Troyan		Bulgaria	5600
39	Pfizer Investigational Site	Zagreb		Croatia	10000
40	Pfizer Investigational Site	Kutna Hora		Czechia	283 01
41	Pfizer Investigational Site	Liberec		Czechia	460 01
42	Pfizer Investigational Site	Praha 5		Czechia	153 00
43	Pfizer Investigational Site	Tabor		Czechia	39001
44	Pfizer Investigational Site	Berlin		Germany	12687
45	Pfizer Investigational Site	Berlin		Germany	14057
46	Pfizer Investigational Site	Frankfurt		Germany	60596
47	Pfizer Investigational Site	Hamburg		Germany	20354
48	Pfizer Investigational Site	Kassel		Germany	34121
49	Pfizer Investigational Site	Luebeck		Germany	23552
50	Pfizer Investigational Site	Schwerin		Germany	19055
51	Pfizer Investigational Site	Wiesbaden		Germany	65187
52	Pfizer Investigational Site	Budapest		Hungary	1125
53	Pfizer Investigational Site	Debrecen		Hungary	4012
54	Pfizer Investigational Site	Szeged		Hungary	6772
55	Pfizer Investigational Site	Szombathely		Hungary	9700
56	Pfizer Investigational Site	Torokbalint		Hungary	2045
57	Pfizer Investigational Site	Lodz		Poland	90-153
58	Pfizer Investigational Site	Sopot		Poland	81-741
59	Pfizer Investigational Site	Warszawa		Poland	04-141
60	Pfizer Investigational Site	Wejherowo		Poland	84-200
61	Pfizer Investigational Site	Bojnice		Slovakia	972 01
62	Pfizer Investigational Site	Bratislava		Slovakia	826 06
63	Pfizer Investigational Site	Liptovsky Hradok		Slovakia	033 01
64	Pfizer Investigational Site	Nove Zamky		Slovakia	940 01
65	Pfizer Investigational Site	Poprad		Slovakia	058 01
66	Pfizer Investigational Site	Spisska Nova Ves		Slovakia	052 01
67	Pfizer Investigational Site	Bellville	Cape Town	South Africa	7530
68	Pfizer Investigational Site	Tygerberg	Cape Town	South Africa	7505
69	Pfizer Investigational Site	Bloemfontein	Free State	South Africa	9301
70	Pfizer Investigational Site	Bloemfontein		South Africa
71	Pfizer Investigational Site	Gatesville, Cape Town		South Africa	7764
72	Pfizer Investigational Site	Salt	Girona	Spain	17190
73	Pfizer Investigational Site	Pozuelo de Alarcon	Madrid	Spain	28223
74	Pfizer Investigational Site	Istanbul		Turkey	34098
75	Pfizer Investigational Site	Izmir		Turkey	35100