Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease. - Full Text View

Purpose

Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: UK-432,097 Drug: Placebo	Phase 2

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 Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group Study To Evaluate the Efficacy And Safety of UK-432,097 Dry Powder For Inhalation In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in trough forced expiratory volume (FEV1) at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC) at 2 and 4 weeks of therapy and at week 8 (2 weeks after the completion of therapy). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in trough FEV6, FVC and IC at week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Change from baseline in post-study drug FEV1, FEV6, FVC and IC at weeks 2, 4 and 6. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Change in vital signs (pulse & blood pressure) and ECG post-drug [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in post-bronchodilator FEV1, FEV6, FVC and IC at week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Change from baseline in dyspnea (BDI/TDI) at weeks 2, 4 and 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Change from baseline of COPD symptoms, rescue bronchodilator use and PEFR. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Acute change in FEV1 post-study drug compared to pre-study drug [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	87
Study Start Date:	January 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 150mcg, 450mcg or 1350mcg Active treatment given BID via a double pin monodose capsule inhaler device	Drug: UK-432,097 Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.
Placebo Comparator: Placebo Placebo treatment given BID via a single pin monodose inhaler device	Drug: Placebo Capsules containing 100% lactose administered BID using an atomizer device

Eligibility

Criteria

Inclusion Criteria:

Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease
Patients must have a smoking history of at least 10 pack-years
Patients must have stable disease for at least 1 month prior to screening.

Exclusion Criteria:

More than 2 exacerbations of COPD in the preceding year
History of a lower respiratory tract infection or significant disease instability during the month proceding screening or during the time between screen and randomization.
History or presence of respiratory failure, cor pulmonale or right ventricular failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430300

Locations

Australia, New South Wales
Pfizer Investigational Site
Camperdown, New South Wales, Australia, 2050
Pfizer Investigational Site
Glebe, New South Wales, Australia, 2037
Australia, South Australia
Pfizer Investigational Site
Daw Park, South Australia, Australia, 5041
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T1Y 6J4
Pfizer Investigational Site
Red Deer, Alberta, Canada, T4N 6V7
Canada, Ontario
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Pfizer Investigational Site
Québec, Quebec, Canada, G1V 4G5
Pfizer Investigational Site
Trois-Rivières, Quebec, Canada, G8T 7A1
Netherlands
Pfizer Investigational Site
Almelo, Netherlands, 7609 PP
Pfizer Investigational Site
Eindhoven, Netherlands, 5623 EJ
Pfizer Investigational Site
Zuthpen, Netherlands, 7207 BA
Poland
Pfizer Investigational Site
Bydgoszcz, Poland, 85-326
Pfizer Investigational Site
Gdansk, Poland, 80-952
Pfizer Investigational Site
Lodz, Poland, 90-153
Pfizer Investigational Site
Warszawa, Poland, 01-138
United Kingdom
Pfizer Investigational Site
Chertsey, Surrey, United Kingdom, KT16 0PZ
Pfizer Investigational Site
Leicester, United Kingdom, LE3 9QP
Pfizer Investigational Site
London, United Kingdom, E2 9ZY
Pfizer Investigational Site
Manchester, United Kingdom, M23 QZ
Pfizer Investigational Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Pfizer Investigational Site
Southampton, United Kingdom, SO16 6YD

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00430300 History of Changes
Other Study ID Numbers:	A3971013
Study First Received:	January 30, 2007
Last Updated:	February 20, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Dry Powder for Inhalation
Chronic Obstructive Pulmonary Disease
Lung Function testing

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013