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

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ClinicalTrials.gov Identifier: NCT00830427
Recruitment Status : Withdrawn
First Posted : January 27, 2009
Last Update Posted : March 15, 2011
Information provided by:

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : July 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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
Placebo Comparator: Placebo Other: Placebo
QD, dry powder inhaler

Primary Outcome Measures :
  1. Change from baseline trough (24 hours post-dose) FEV1. [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830427

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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00830427     History of Changes
Other Study ID Numbers: A7881006
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: March 15, 2011
Last Verified: March 2011

Keywords provided by Pfizer:
asthma bronchial diseases

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