A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00830427

Purpose

This study (A7881006) is the first multiple dose study in moderate asthmatic subjects and aims to determine the safety and efficacy of PF-00610355 when subjects take PF-00610355 on a daily basis for 4 weeks in subjects maintained on inhaled corticosteroid.

Condition	Intervention	Phase
Asthma, Bronchial Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases	Drug: PF-00610355 Drug: PF - 00610355 Other: 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 IIb Randomised, Double Blind, Placebo Controlled Parallel Group Study To Investigate The Efficacy And Safety Of PF-00610355 Over 4 Weeks In Moderately Asthmatic Subjects.

Resource links provided by NLM:

MedlinePlus related topics: Asthma Bronchial Disorders

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline trough (24 hours post-dose) FEV1. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in heart rate. [ Time Frame: week 0, week 4 ] [ Designated as safety issue: Yes ]
Change from baseline in trough FEV1. [ Time Frame: week 4 ] [ Designated as safety issue: No ]
Maximum change from baseline in FEV1 from 0 to 6 hours post-dose. [ Time Frame: week 0,week 4 ] [ Designated as safety issue: No ]
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score. [ Time Frame: week 2, week 4 ] [ Designated as safety issue: No ]
Pharmacokinetics of PF-00610355. [ Time Frame: week 0, week 4 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	350
Study Start Date:	July 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PF-00610355	Drug: PF-00610355 100 mcg, QD, dry powder inhaler
Experimental: PF - 00610355	Drug: PF - 00610355 600 mcg, QD, dry powder inhaler
Placebo Comparator: Placebo	Other: Placebo QD, dry powder inhaler
Experimental: PF - 00610355	Drug: PF - 00610355 300 mcg, QD, dry powder inhaler

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with a physician documented history or diagnosis of persistent asthma for at least 6 months prior to Screening Visit 1.
Trough FEV1 must be 50-100% of predicted at Screening Visit 1.
Subjects who have been maintained on a stable dose of ICS over the previous month prior to screening.

Exclusion Criteria:

Subjects who have had a severe asthma exacerbation in the 2 months prior to screening.
Subjects meeting any of the criteria of 'very poorly controlled' according to the NIH EPR 3 guidelines.
Subjects with evidence or history of cardiovascular disease including angina, myocardial, infarction, clinically significant cardiac arrhythmia (eg, atrial fibrillation, atrial flutter,supraventricular tachycardia, ventricular tachycardia), systemic hypertension (SBP > 160 mmHg or DBP >100mmHg), pulmonary hypertension or cerebrovascular disease (including transient ischaemic attacks).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830427

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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00830427 History of Changes
Other Study ID Numbers:	A7881006
Study First Received:	January 26, 2009
Last Updated:	March 11, 2011
Health Authority:	Germany: German Institute of Medical Documentation and Information

Keywords provided by Pfizer:

asthma bronchial diseases

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 24, 2012