A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients. - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00808288

Purpose

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

Condition	Intervention	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 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 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.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Potassium

Drug Information available for: Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in trough FEV1 [ Time Frame: 6 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximal and mean changes from baseline in heart rate, QTc and plasma potassium [ Time Frame: each visit ] [ Designated as safety issue: Yes ]
Change from baseline in peak FEV1 [ Time Frame: 0-6 hours /6 weeks ] [ Designated as safety issue: No ]
Change from baseline in trough and peak FEV6, FVC and IC [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC) [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]
Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS) [ Time Frame: 2,4,6 weeks ] [ Designated as safety issue: No ]
Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary). [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Enrollment:	405
Study Start Date:	March 2010
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808288

Show 75 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00808288 History of Changes
Other Study ID Numbers:	A7881013
Study First Received:	December 12, 2008
Last Updated:	October 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

COPD Respiratory Long acting beta agonist

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Salmeterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

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

ClinicalTrials.gov processed this record on May 24, 2012