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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00830427
First received: January 26, 2009
Last updated: March 11, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Asthma, Bronchial
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Drug: PF-00610355
Drug: PF - 00610355
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Moderately Asthmatic Subjects.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline trough (24 hours post-dose) FEV1. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in heart rate. [ Time Frame: week 0, week 4 ] [ Designated as safety issue: Yes ]
  • Change from baseline in trough FEV1. [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • Maximum change from baseline in FEV1 from 0 to 6 hours post-dose. [ Time Frame: week 0,week 4 ] [ Designated as safety issue: No ]
  • Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score. [ Time Frame: week 2, week 4 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of PF-00610355. [ Time Frame: week 0, week 4 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: July 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-00610355 Drug: PF-00610355
100 mcg, QD, dry powder inhaler
Experimental: PF - 00610355 Drug: PF - 00610355
600 mcg, QD, dry powder inhaler
Placebo Comparator: Placebo Other: Placebo
QD, dry powder inhaler
Experimental: PF - 00610355 Drug: PF - 00610355
300 mcg, QD, dry powder inhaler

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830427

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00830427     History of Changes
Other Study ID Numbers: A7881006
Study First Received: January 26, 2009
Last Updated: March 11, 2011
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Pfizer:
asthma bronchial diseases

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bronchial Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014