Status:
TERMINATED
An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
Lead Sponsor:
Pfizer
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT02219048
Start Date
November 1 2014
End Date
May 1 2015
Last Update
June 12 2019
Active Locations (28)
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1
Clinical Research Center of Alabama
Birmingham, Alabama, United States, 35209
2
Pulmonary Associates, Pa
Phoenix, Arizona, United States, 85006
3
Little Rock Allergy & Asthma Clinical Research Center
Little Rock, Arkansas, United States, 72205-4565
4
California Research Medical Group, Inc
Fullerton, California, United States, 92835