PF-04191834 Single Dose Bronchodilatory Study In Asthma.

Asthma Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723021
• Other study ID #: B0041002
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2008
• Last updated: December 27, 2012
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• PF-04191834
30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.
• PF-04191834
100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.
• PF-04191834
2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose
• zileuton
1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.
• Placebo
2 x placebo tablets + placebo oral dispersion, single dose.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	North Dartmouth	Massachusetts
United States	Pfizer Investigational Site	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.	No
Other	Maximum Observed Plasma Concentration (Cmax)		Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.	No
Other	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.	No
Other	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.	No
Other	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	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).	14 and 24 hours following dosing in each period.	No
Primary	Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)	The FEV1 is the maximal volume of air that can be forcefully exhaled in one second	Baseline, 12 hours (hrs) post-dose	No
Primary	Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)	The FEV1 is the maximal volume of air that can be forcefully exhaled in one second	Baseline, 24 hours (hrs) post-dose	No
Secondary	Change From Baseline in Forced Vital Capacity (FVC)	The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible	Baseline, 12 hours (hrs) post-dose	No
Secondary	Change From Baseline in Forced Vital Capacity (FVC)	The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible	Baseline,24 hours (hrs) post-dose	No
Secondary	Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)	The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity	Baseline, 12 hours (hrs) post-dose	No
Secondary	Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)	The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity	Baseline, 24 hours (hrs) post-dose	No

External Links

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