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A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT01033487
Recruitment Status : Completed
First Posted : December 16, 2009
Results First Posted : February 19, 2016
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 15, 2009
First Posted Date  ICMJE December 16, 2009
Results First Submitted Date  ICMJE August 9, 2012
Results First Posted Date  ICMJE February 19, 2016
Last Update Posted Date February 19, 2016
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2016)
  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, 24, 24.5 hrs post-dose ]
    FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose. Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period. Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose ]
  • Dose Normalized Maximum Observed Plasma Concentration [ Time Frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose ]
    Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
  • Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [ Time Frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)] [ Time Frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose ]
    AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞).
  • Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time [ Time Frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose ]
    AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞). AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2009)
  • FEV1 change from baseline [ Time Frame: 0-48hrs ]
  • PK parameters (Cmax, Tmax, AUClast, AUCinf, T½). [ Time Frame: 0-48hrs ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2016)
  • Peak Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline up to 48 hrs post-dose ]
    FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Peak FEV1 was defined as change from baseline in maximum FEV1. Maximum FEV1 = maximum forced expiratory volume in 1 second, recorded between 0.5 hrs to 48 hrs post-dose. Baseline FEV1 value was calculated as average of two largest pre-dose readings on Day 1 for each period.
  • Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response [ Time Frame: Baseline up to 24.5 hrs post-dose ]
    FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Weighted average FEV1 was defined as the average area under the effect curve (AUEC) change from baseline FEV1 (the area under the FEV1 effect curve over 24.5 hrs post-dose for each study period corrected for the pre-dose baseline value) divided by 24.5. Baseline FEV1 value was calculated as the average of two largest pre-dose readings on Day 1 for each period.
  • Change From Baseline in Force Vital Capacity (FVC) [ Time Frame: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose ]
    FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Baseline FVC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in FVC was the difference between FVC and baseline FVC.
  • Change From Baseline in Inspiratory Capacity (IC) [ Time Frame: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose ]
    IC was the maximum volume of air that can be inhaled in to the lungs after breathing out normally. Baseline IC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in IC was the difference between IC and baseline IC.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2009)
  • Peak FEV1 - change from baseline in maximum FEV1 [ Time Frame: 0-48hrs ]
  • Average AUEC change from baseline FEV1 [ Time Frame: 0-48hrs ]
  • Force Vital Capacity (FVC) [ Time Frame: 0-48hrs ]
  • Inspiratory Capacity (IC) [ Time Frame: 0-48hrs ]
  • Adverse Events, Blood pressure, pulse rate, ECG [ Time Frame: 0-48hrs ]
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, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
Official Title  ICMJE A Phase 2A, Double Blind, Placebo-Controlled, Single Dose, 5-Way Crossover Study Assessing The Pharmacodynamic, Pharmacokinetic And Safety Profiles Of Oral Inhaled PF-03635659 In Patients With Moderate Chronic Obstructive Pulmonary Disease.
Brief Summary PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases
  • Respiratory Tract Diseases
  • Chronic Obstructive Airway Disease
  • COPD
Intervention  ICMJE
  • Drug: placebo
    oral inhaled formulation, single dose
  • Drug: active comparator
    oral inhaled formulation, single dose
  • Drug: Low Dose PF-03635659
    oral inhaled formulation, single dose, low dose
  • Drug: Mid Dose PF-03635659
    oral inhaled formulation, single dose, mid dose
  • Drug: High Dose PF-03635659
    oral inhaled formulation, single dose, high dose
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Active Comparator: active comparator
    Intervention: Drug: active comparator
  • Experimental: PF-03635659
    Interventions:
    • Drug: Low Dose PF-03635659
    • Drug: Mid Dose PF-03635659
    • Drug: High Dose PF-03635659
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: September 27, 2010)
22
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2009)
25
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
  • Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88 lbs).
  • Current smokers, or ex-smokers who have abstained from smoking for at least 6 months

Exclusion Criteria:

  • Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
  • History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01033487
Other Study ID Numbers  ICMJE B0431010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2016

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