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

• ClinicalTrials.gov Identifier: NCT00830427
• Recruitment Status: Withdrawn
• First Posted: January 27, 2009
• Last Update Posted: January 31, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: January 26, 2009
• First Posted Date: January 27, 2009
• Last Update Posted Date: January 31, 2019
• Actual Study Start Date: April 15, 2009
• Estimated Primary Completion Date: December 31, 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 26, 2009): Change from baseline trough (24 hours post-dose) FEV1. [ Time Frame: 4 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects
• 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 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

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

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: January 29, 2019): 0
• Original Estimated Enrollment (submitted: January 26, 2009): 350
• Estimated Study Completion Date: December 31, 2009
• Estimated Primary Completion Date: December 31, 2009 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00830427
• Other Study ID Numbers: A7881006; 2008-007183-42 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: January 2019