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NCT00830427 Clinical Trial

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

Lung Diseases, Obstructive Clinical Trial

— A7881006  

Official title:
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.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00830427
Other study ID # A7881006
Secondary ID 2008-007183-42
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date April 15, 2009
Est. completion date December 31, 2009

Study information
Verified date January 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 31, 2009
Est. primary completion date December 31, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• PF-00610355
100 mcg, QD, dry powder inhaler
• PF - 00610355
600 mcg, QD, dry powder inhaler
Other:
• Placebo
QD, dry powder inhaler
Drug:
• PF - 00610355
300 mcg, QD, dry powder inhaler

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline trough (24 hours post-dose) FEV1. 4 weeks
Secondary Change from baseline in heart rate. week 0, week 4
Secondary Change from baseline in trough FEV1. week 4
Secondary Maximum change from baseline in FEV1 from 0 to 6 hours post-dose. week 0,week 4
Secondary Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score. week 2, week 4
Secondary Pharmacokinetics of PF-00610355. week 0, week 4
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