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This study has been withdrawn prior to enrollment.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
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:
Asthma
Bronchial Diseases
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 22, 2014