Lung Diseases, Obstructive Clinical Trial
— A7881006Official 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.
Verified date | January 2019 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
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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