A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.

NCT00468975

Last updated date
Study Location
Pfizer Investigational Site
Berlin, , 14050, Germany
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
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Reversible asthmatic patients (>15% increase in FEV1 following 200ug salbutamol).

- FEV1 greater than or equal to 60% predicted

- Stable disease for at least the previous 3 months

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


- Subjects requiring rescue medication on greater than 2 occasions in the 72 hours prior
to screening


- Subjects with a history of pulmonary disease other than asthma.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.
Official Title  ICMJE A Phase IIA Randomised, Double-blind, Double Dummy, Placebo and Active Controlled 5-Way Cross-over Trial to Examine the Bronchodilator Effects of PF-610,355 and to Test for Superiority Versus Placebo in Reversible Asthmatic Patients
Brief Summary A study to determine the ability of different doses of PF-610,355 to open the airways in asthmatic patients by comparison with placebo and a marketed drug that also opens the airways in asthmatic patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: PF-610,355
  • Drug: Salmeterol
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: May 2, 2007)
42
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Reversible asthmatic patients (>15% increase in FEV1 following 200ug salbutamol).
  • FEV1 greater than or equal to 60% predicted
  • Stable disease for at least the previous 3 months

Exclusion Criteria:

  • Subjects requiring rescue medication on greater than 2 occasions in the 72 hours prior to screening
  • Subjects with a history of pulmonary disease other than asthma.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00468975
Other Study ID Numbers  ICMJE A7881004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2010

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