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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-15

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma, Bronchial Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PF-00610355

Group Type EXPERIMENTAL

PF-00610355

Intervention Type DRUG

100 mcg, QD, dry powder inhaler

PF - 00610355

Group Type EXPERIMENTAL

PF - 00610355

Intervention Type DRUG

600 mcg, QD, dry powder inhaler

PF - 00610355

Intervention Type DRUG

300 mcg, QD, dry powder inhaler

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

QD, dry powder inhaler

Interventions

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PF-00610355

100 mcg, QD, dry powder inhaler

Intervention Type DRUG

PF - 00610355

600 mcg, QD, dry powder inhaler

Intervention Type DRUG

Placebo

QD, dry powder inhaler

Intervention Type OTHER

PF - 00610355

300 mcg, QD, dry powder inhaler

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No