Skip to main content
OpenTrials
Completed

NCT Number: NCT00723021

PF-04191834 Single Dose Bronchodilatory Study In Asthma.

Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persistent mild/moderate asthma for at least 6 months.
  • Reduced lung function
  • Reversible airway obstruction

Exclusion criteria

  • Pregnant/nursing females.
  • Liver function tests greater than upper limit of normal (ULN)

Treatment and study plan

PF-04191834

Drug

30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.

zileuton

Drug

1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.

Placebo

Drug

2 x placebo tablets + placebo oral dispersion, single dose.

Primary outcomes

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

    Time frame: Baseline, 12 hours (hrs) post-dose

    The FEV1 is the maximal volume of air that can be forcefully exhaled in one second

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

    Time frame: Baseline, 24 hours (hrs) post-dose

    The FEV1 is the maximal volume of air that can be forcefully exhaled in one second

Secondary outcomes

  1. Change From Baseline in Forced Vital Capacity (FVC)

    Time frame: Baseline, 12 hours (hrs) post-dose

    The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible

  2. Change From Baseline in Forced Vital Capacity (FVC)

    Time frame: Baseline,24 hours (hrs) post-dose

    The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible

  3. Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)

    Time frame: Baseline, 12 hours (hrs) post-dose

    The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity

  4. Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)

    Time frame: Baseline, 24 hours (hrs) post-dose

    The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity

Other outcomes

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

    Time frame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.

  4. Plasma Decay Half-Life (t1/2)

    Time frame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.

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

  5. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

    Time frame: 14 and 24 hours following dosing in each period.

    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 2a, Randomised, Double-Blind (3rd Party Open), Double-Dummy, Placebo And Active Controlled 5-Way Crossover Study To Assess The Bronchodilatory Action, Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04191834 In Asthmatic Patients.

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jul 28, 2008
Registry last updated
Feb 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.