A Study To Investigate The Safety, Toleration And Efficac... | NCT00808288

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.

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Dec 12, 2008

First Submission Date that Met QC Criteria

Dec 12, 2008

First Posted Date

Dec 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Feb 1, 2019

Certification/Extension First Submitted that Passed QC Review

Feb 1, 2019

Certification/Extension First Posted Date

Feb 6, 2019Actual

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

405Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
PF-00610355	Experimental	Drug: PF-00610355
PF- 00610355	Experimental	Drug: PF - 00610355
PF - 00610355	Experimental	Drug: PF- 00610355
Placebo	Placebo Comparator	Drug: Placebo
Salmeterol	Active Comparator	Drug: Salmeterol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-00610355	Drug	oral, inhaled, dry powder, 600ug, OD	PF-00610355

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in trough FEV1		6 week

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Fairhope	Alabama	36532	United States
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C552705	N-((4'-hydroxybiphenyl-3-yl)methyl)-2-(3-(2-((-2-hydroxy-2-(4-hydroxy-3-((methylsulfonyl)amino)phenyl)ethyl)amino)-2-methylpropyl)phenyl)acetamide
D000068299	Salmeterol Xinafoate

ID	Term
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D008171	Lung Diseases
D008173	Lung Diseases, Obstructive