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A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients. (A7881013)

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: NCT00808288
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 12, 2008
First Posted Date  ICMJE December 15, 2008
Last Update Posted Date February 6, 2019
Study Start Date  ICMJE March 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
Change from baseline in trough FEV1 [ Time Frame: 6 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
  • Maximal and mean changes from baseline in heart rate, QTc and plasma potassium [ Time Frame: each visit ]
  • Change from baseline in peak FEV1 [ Time Frame: 0-6 hours /6 weeks ]
  • Change from baseline in trough and peak FEV6, FVC and IC [ Time Frame: 6 weeks ]
  • Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC) [ Time Frame: 2 and 4 weeks ]
  • Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS) [ Time Frame: 2,4,6 weeks ]
  • Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary). [ Time Frame: weekly ]
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 Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.
Official Title  ICMJE A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease.
Brief Summary To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases
  • Lung Diseases, Obstructive
Intervention  ICMJE
  • Drug: PF-00610355
    oral, inhaled, dry powder, 600ug, OD
  • Drug: PF - 00610355
    oral, inhaled, dry powder, 300ug, OD
  • Drug: PF- 00610355
    oral, inhaled, dry powder, 100ug, OD
  • Drug: Placebo
    oral, inhaled, dry powder, placebo, OD
  • Drug: Salmeterol
    salmeterol, 50ug, BID
Study Arms  ICMJE
  • Experimental: PF-00610355
    Intervention: Drug: PF-00610355
  • Experimental: PF- 00610355
    Intervention: Drug: PF - 00610355
  • Experimental: PF - 00610355
    Intervention: Drug: PF- 00610355
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Salmeterol
    Intervention: Drug: Salmeterol
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2011)
405
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2008)
380
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%.
  • Diagnosis of moderate COPD for a minimum of 6 months.
  • Stable disease for at least 1 month prior to screening

Exclusion Criteria:

  • More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
  • History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 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 Argentina,   Bulgaria,   Croatia,   Czechia,   Germany,   Hungary,   Poland,   Slovakia,   South Africa,   Spain,   Turkey,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00808288
Other Study ID Numbers  ICMJE A7881013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 February 2019

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