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

Pfizer

Status and phase

Terminated

Phase 2

Conditions

Asthma

Treatments

Drug: PF-03715455

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02219048

A9111007

INHALED P38I ASTHMA (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

51 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.