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PF-04191834 Single Dose Bronchodilatory Study In Asthma.

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Baltimore, Maryland, 21225 United States
Contact
1-800-718-1021
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)

NCT00723021
Pfizer
Completed
PF-04191834 Single Dose Bronchodilatory Study In Asthma.

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PF-04191834 Single Dose Bronchodilatory Study In Asthma.
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.
Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2009
December 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00723021
B0041002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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