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An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma

NCT ID: NCT02219048

Last Updated: 2019-06-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-05-31

Brief Summary

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The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe asthma when added to standard of care and during staged withdrawal of background therapy.

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Detailed Description

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Study terminated on 7th April 2015. The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Matched blinded placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

680 micrograms BID, Orally inhaled placebo for 12 weeks

PF-03715455

PF-03715455

Group Type EXPERIMENTAL

PF-03715455

Intervention Type DRUG

680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks

Interventions

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Placebo

680 micrograms BID, Orally inhaled placebo for 12 weeks

Intervention Type DRUG

PF-03715455

680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with a physician documented history or diagnosis of persistent asthma (according to GINA, 2014 definition of asthma),
* Pre bronchodilator FEV1 of greater than or equal to 50 and less that 80% of predicted.
* Subjects defined as GINA Step 4 on a stable dose of either fluticasone/salmeterol combination therapy, or budesonide/formoterol combination therapy or mometasone/formoterol combination therapy.
* Subjects who are defined as uncontrolled as evidenced by; Juniper Asthma Control Questionnaire (5 item version, ACQ) score greater than or equal to 1.5 and less than or equal to 3.0)

Exclusion Criteria

* Subjects diagnosed with chronic pulmonary disease (COPD) and/or other chronic pulmonary diseases (eg, Occupational asthma, pulmonary fibrosis, bronchiectasis, Allergic bronchopulmonary aspergillosis (ABPA), pneumoconiosis, sarcoidosis, tuberculosis).
* Subjects who are current smokers.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Clinical Research Center of Alabama

Birmingham, Alabama, United States

Site Status

Pulmonary Associates, Pa

Phoenix, Arizona, United States

Site Status

Little Rock Allergy & Asthma Clinical Research Center

Little Rock, Arkansas, United States

Site Status

California Research Medical Group, Inc

Fullerton, California, United States

Site Status

California Allergy and Asthma Medical Group, Inc.

Los Angeles, California, United States

Site Status

Jonathan Corren MD, Inc.

Los Angeles, California, United States

Site Status

Integrated Research Group, Incorporated

Riverside, California, United States

Site Status

Peninsula Research Associates

Rolling Hills Estates, California, United States

Site Status

Allergy Associates Medical Group

San Diego, California, United States

Site Status

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, United States

Site Status

Colorado Allergy and Asthma Centers, PC

Denver, Colorado, United States

Site Status

University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit

Tampa, Florida, United States

Site Status

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, United States

Site Status

Chesapeake Clinical Research, Inc.

Baltimore, Maryland, United States

Site Status

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, United States

Site Status

Clinical Research Institute

Minneapolis, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Associated Specialists in Medicine, PC

St Louis, Missouri, United States

Site Status

The Clinical Research Center, L.L.C.

St Louis, Missouri, United States

Site Status

The Asthma and Allergy Center

Bellevue, Nebraska, United States

Site Status

North Shore Long Island Jewish Health System

New Hyde Park, New York, United States

Site Status

American Health Research

Charlotte, North Carolina, United States

Site Status

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Bernstein Clinical Research Center

Cincinnati, Ohio, United States

Site Status

University of Pittsburgh Asthma Institute

Pittsburgh, Pennsylvania, United States

Site Status

Upstate Pharmaceutical Research

Greenville, South Carolina, United States

Site Status

The Allergy & Asthma Clinic of Central Texas

Killeen, Texas, United States

Site Status

University of Wisconsin School of Medicine & Public Health

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9111007&StudyName=An%20Evaluation%20Of%20PF-03715455%20In%20Moderate%20To%20Severe%20Uncontrolled%20Asthma

To obtain contact information for a study center near you, click here.

Other Identifiers

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INHALED P38I ASTHMA

Identifier Type: OTHER

Identifier Source: secondary_id

A9111007

Identifier Type: -

Identifier Source: org_study_id

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