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

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.

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00830427

Acronym

A7881006

Enrollment

Registered

2009-01-27

Start date

2009-04-15

Completion date

2009-12-31

Last updated

2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

asthma bronchial diseases

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.

Interventions

DRUGPF-00610355

100 mcg, QD, dry powder inhaler

DRUGPF - 00610355

600 mcg, QD, dry powder inhaler

OTHERPlacebo

QD, dry powder inhaler

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026