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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02219048

Run by

Pfizer

People needed

51

Starts

2014-11-01

Expected to finish

2015-05-01

Last updated by the study team

2019-06-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Clinical Research Center of Alabama — Birmingham, Alabama, United States
• Pulmonary Associates, Pa — Phoenix, Arizona, United States
• Little Rock Allergy & Asthma Clinical Research Center — Little Rock, Arkansas, United States
• California Research Medical Group, Inc — Fullerton, California, United States
• California Allergy and Asthma Medical Group, Inc. — Los Angeles, California, United States
• Jonathan Corren MD, Inc. — Los Angeles, California, United States
• Integrated Research Group, Incorporated — Riverside, California, United States
• Peninsula Research Associates — Rolling Hills Estates, California, United States
• Allergy Associates Medical Group — San Diego, California, United States
• Asthma and Allergy Associates, PC — Colorado Springs, Colorado, United States
• Colorado Allergy and Asthma Centers, PC — Denver, Colorado, United States
• University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit — Tampa, Florida, United States
• Florida Pulmonary Research Institute, LLC — Winter Park, Florida, United States
• Chesapeake Clinical Research, Inc. — Baltimore, Maryland, United States
• Northeast Medical Research Associates, Inc. — North Dartmouth, Massachusetts, United States
• Clinical Research Institute — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Associated Specialists in Medicine, PC — St Louis, Missouri, United States
• The Clinical Research Center, L.L.C. — St Louis, Missouri, United States
• The Asthma and Allergy Center — Bellevue, Nebraska, United States
• North Shore Long Island Jewish Health System — New Hyde Park, New York, United States
• American Health Research — Charlotte, North Carolina, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• Bernstein Clinical Research Center — Cincinnati, Ohio, United States
• University of Pittsburgh Asthma Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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