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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

placebo

active comparator

Low Dose PF-03635659

Mid Dose PF-03635659

High Dose PF-03635659

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Safety, Pharmacokinetics, Pharmacodynamics, PF-03635659, COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

active comparator

PF-03635659

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)

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)

Dose Normalized Maximum Observed Plasma Concentration

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)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

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

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-∞)]

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

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)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Secondary Outcome Measures

Peak Forced Expiratory Volume in 1 Second (FEV1)

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

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)

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)

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.

Full Information

NCT ID

NCT01033487

First Posted

December 15, 2009

Last Updated

January 22, 2016

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01033487

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Tract Diseases, Chronic Obstructive Airway Disease, COPD

Keywords

Safety, Pharmacokinetics, Pharmacodynamics, PF-03635659, COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

active comparator

Arm Type

Active Comparator

Arm Title

PF-03635659

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral inhaled formulation, single dose

Intervention Type

Drug

Intervention Name(s)

active comparator

Intervention Description

oral inhaled formulation, single dose

Intervention Type

Drug

Intervention Name(s)

Low Dose PF-03635659

Intervention Description

oral inhaled formulation, single dose, low dose

Intervention Type

Drug

Intervention Name(s)

Mid Dose PF-03635659

Intervention Description

oral inhaled formulation, single dose, mid dose

Intervention Type

Drug

Intervention Name(s)

High Dose PF-03635659

Intervention Description

oral inhaled formulation, single dose, high dose

Primary Outcome Measure Information:

Title

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)

Description

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.

Time Frame

Baseline, 24, 24.5 hrs post-dose

Title

Maximum Observed Plasma Concentration (Cmax)

Time Frame