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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00830427
Recruitment Status : Withdrawn
First Posted : January 27, 2009
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 26, 2009
First Posted Date  ICMJE January 27, 2009
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE April 15, 2009
Estimated Primary Completion Date December 31, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2009)
Change from baseline trough (24 hours post-dose) FEV1. [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2009)
  • Change from baseline in heart rate. [ Time Frame: week 0, week 4 ]
  • Change from baseline in trough FEV1. [ Time Frame: week 4 ]
  • Maximum change from baseline in FEV1 from 0 to 6 hours post-dose. [ Time Frame: week 0,week 4 ]
  • Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score. [ Time Frame: week 2, week 4 ]
  • Pharmacokinetics of PF-00610355. [ Time Frame: week 0, week 4 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma, Bronchial
  • Lung Diseases, Obstructive
  • Respiratory Tract Diseases
  • Bronchial Diseases
Intervention  ICMJE
  • Drug: PF-00610355
    100 mcg, QD, dry powder inhaler
  • Drug: PF - 00610355
    600 mcg, QD, dry powder inhaler
  • Other: Placebo
    QD, dry powder inhaler
  • Drug: PF - 00610355
    300 mcg, QD, dry powder inhaler
Study Arms  ICMJE
  • Experimental: PF-00610355
    Intervention: Drug: PF-00610355
  • Experimental: PF - 00610355
    Interventions:
    • Drug: PF - 00610355
    • Drug: PF - 00610355
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 29, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2009)
350
Estimated Study Completion Date  ICMJE December 31, 2009
Estimated Primary Completion Date December 31, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00830427
Other Study ID Numbers  ICMJE A7881006
2008-007183-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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
Current Responsible Party Pfizer
Original Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP