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

Phase 2

Withdrawn

• Conditions: Asthma, Bronchial; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Tract Diseases
• Interventions: Drug: PF - 00610355; Other: Placebo; Drug: PF-00610355

• Registration Number: NCT00830427
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Study Start: 2009-04-15
• Primary Completion: 2009-12-31
• Study Completion: 2009-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF - 00610355	PF - 00610355	-
Placebo	Placebo	-
PF-00610355	PF-00610355	-

Primary Outcome Measures

Name	Time	Method
Change from baseline trough (24 hours post-dose) FEV1.	4 weeks

Secondary Outcome Measures

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