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

NCT00830427 | Withdrawn Phase 2

• 2 other identifiers: A78810062008-007183-42
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

asthma bronchial diseases

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (5)

• 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

Study Arms (3)

PF-00610355

EXPERIMENTAL

Drug: PF-00610355

PF - 00610355

EXPERIMENTAL

Drug: PF - 00610355

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

PF-00610355 DRUG

100 mcg, QD, dry powder inhaler

PF-00610355

PF - 00610355 DRUG

600 mcg, QD, dry powder inhaler

PF - 00610355

Placebo OTHER

QD, dry powder inhaler

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

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

Interventions

N-((4'-hydroxybiphenyl-3-yl)methyl)-2-(3-(2-((-2-hydroxy-2-(4-hydroxy-3-((methylsulfonyl)amino)phenyl)ethyl)amino)-2-methylpropyl)phenyl)acetamide

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: April 15, 2009
• Primary Completion: December 31, 2009
• Study Completion: December 31, 2009
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share