A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects (A7881006)

January 29, 2019 updated by: Pfizer

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.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2009

Primary Completion (Anticipated)

December 31, 2009

Study Completion (Anticipated)

December 31, 2009

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7881006
  • 2008-007183-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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