PF-04191834 Single Dose Bronchodilatory Study In Asthma.

NCT00723021

Last updated date
Study Location
Pfizer Investigational Site
Baltimore, Maryland, 21225, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Persistent mild/moderate asthma for at least 6 months.

- Reduced lung function

- Reversible airway obstruction

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pregnant/nursing females.


- Liver function tests greater than upper limit of normal (ULN)

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Advanced Information
Descriptive Information
Brief Title  ICMJE PF-04191834 Single Dose Bronchodilatory Study In Asthma.
Official Title  ICMJE 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.
Brief Summary Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: PF-04191834
    30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.
  • Drug: PF-04191834
    100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.
  • Drug: PF-04191834
    2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose
  • Drug: zileuton
    1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.
  • Drug: Placebo
    2 x placebo tablets + placebo oral dispersion, single dose.
Study Arms  ICMJE
  • Experimental: PF-04191834 30mg
    Intervention: Drug: PF-04191834
  • Experimental: PF-04191834 100mg
    Intervention: Drug: PF-04191834
  • Experimental: PF-04191834 2000mg
    Intervention: Drug: PF-04191834
  • Active Comparator: zileuton
    Intervention: Drug: zileuton
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
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: July 24, 2008)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00723021
Other Study ID Numbers  ICMJE B0041002
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 CenterPfizer
PRS Account Pfizer
Verification Date December 2012

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