A Blinded Study To Examine The Ability Of PF-610,355 To O... | NCT00468975

Studies
A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.

NCT00468975

Sponsor

Pfizer

Status

Completed

Last Update Posted

Nov 1, 2010Estimated

Enrollment

Phase

Phase 2

Conditions

Asthma

Interventions

PF-610,355
Salmeterol

Countries

Germany
Sweden
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

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

May 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 2, 2007

First Submission Date that Met QC Criteria

May 2, 2007

First Posted Date

May 3, 2007Estimated

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

Mar 24, 2009

Certification/Extension First Submitted that Passed QC Review

Oct 27, 2010

Certification/Extension First Posted Date

Nov 1, 2010Estimated

Last Update Submitted Date

Oct 27, 2010

Last Update Posted Date

Nov 1, 2010Estimated

Description Module

Brief Summary

A study to determine the ability of different doses of PF-610,355 to open the airways in asthmatic patients by comparison with placebo and a marketed drug that also opens the airways in asthmatic patients.

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak and Trough (24 hour post dose) FEV1.

Secondary Outcomes

Measure	Description	Time Frame
Peak and trough (24 hour post dose) PEFR
FEV1 and PEFR measurements to 32 hours post dose.
Pharmacokinetics of PF-610,355 and salmeterol

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Reversible asthmatic patients (>15% increase in FEV1 following 200ug salbutamol).
FEV1 greater than or equal to 60% predicted
Stable disease for at least the previous 3 months

Exclusion Criteria:

Subjects requiring rescue medication on greater than 2 occasions in the 72 hours prior to screening
Subjects with a history of pulmonary disease other than asthma.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 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		Berlin		14050	Germany
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Term
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930

Name	Type	Description	Arm Group Labels	Other Names
PF-610,355	Drug
Salmeterol	Drug