A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects (A7881006)

Pfizer

Status and phase

Withdrawn

Phase 2

Conditions

Lung Diseases, Obstructive

Asthma, Bronchial

Respiratory Tract Diseases

Bronchial Diseases

Treatments

Drug: PF - 00610355

Other: Placebo

Drug: PF-00610355

Study type

Interventional

Funder types

Industry

Identifiers

NCT00830427

A7881006

2008-007183-42 (EudraCT Number)

Details and patient eligibility

About

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.

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 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).