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

Study Overview
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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.

Official Title
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A Phase Iib Randomised Double Blind, Placebo Controlled Parallel Group Study To Investigate The Efficacy And Safety Of Pf-00610355 Over 4 Weeks In Moderate Asthmatic Subjects.

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

Intervention / Treatment
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* Drug: PF-00610355
* Drug: PF - 00610355
* Other: Placebo
* Drug: PF - 00610355


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-00610355<br> | Drug: PF-00610355<br>* 100 mcg, QD, dry powder inhaler<br>|
| Experimental: PF - 00610355<br> | Drug: PF - 00610355<br>* 600 mcg, QD, dry powder inhaler<br>Drug: PF - 00610355<br>* 300 mcg, QD, dry powder inhaler<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* QD, dry powder inhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline trough (24 hours post-dose) FEV1. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in heart rate. |  | week 0, week 4 | 
| Change from baseline in trough FEV1. |  | week 4 | 
| Maximum change from baseline in FEV1 from 0 to 6 hours post-dose. |  | week 0,week 4 | 
| Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score. |  | week 2, week 4 | 
| Pharmacokinetics of PF-00610355. |  | week 0, week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma bronchial diseases