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

Primary Purpose

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

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

PF-00610355

PF - 00610355

Placebo

PF - 00610355

About this trial

This is an interventional treatment trial for Asthma, Bronchial focused on measuring asthma bronchial diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-00610355

PF - 00610355

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline trough (24 hours post-dose) FEV1.

Secondary Outcome Measures

Change from baseline in heart rate.

Change from baseline in trough FEV1.

Maximum change from baseline in FEV1 from 0 to 6 hours post-dose.

Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score.

Pharmacokinetics of PF-00610355.

Full Information

NCT ID

NCT00830427

First Posted

January 26, 2009

Last Updated

January 29, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00830427

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Withdrawn

Study Start Date

April 15, 2009 (Actual)

Primary Completion Date

December 31, 2009 (Anticipated)

Study Completion Date

December 31, 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

asthma bronchial diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-00610355

Arm Type

Experimental

Arm Title

PF - 00610355

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

PF-00610355

Intervention Description

100 mcg, QD, dry powder inhaler

Intervention Type

Drug

Intervention Name(s)

PF - 00610355

Intervention Description

600 mcg, QD, dry powder inhaler

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

QD, dry powder inhaler

Intervention Type

Drug

Intervention Name(s)

PF - 00610355

Intervention Description

300 mcg, QD, dry powder inhaler

Primary Outcome Measure Information:

Title

Change from baseline trough (24 hours post-dose) FEV1.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in heart rate.

Time Frame

week 0, week 4

Title

Change from baseline in trough FEV1.

Time Frame

week 4

Title

Maximum change from baseline in FEV1 from 0 to 6 hours post-dose.

Time Frame

week 0,week 4

Title

Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score.

Time Frame

week 2, week 4

Title

Pharmacokinetics of PF-00610355.

Time Frame

week 0, week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7881006&StudyName=A%20Study%20To%20Examine%20The%20Safety%20And%20Efficacy%20Of%20PF-00610355%20In%20Moderately%20Asthmatic%20Subjects

Description

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

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