Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.

NCT00783406

Last updated date
Study Location
Pfizer Investigational Site
Berlin, , 10117, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Post-bronchodilator FEV1/ FVC ratio of <0.7.

- Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.

- Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.

- Current smokers, or ex-smokers who have abstained from smoking for at least 6 months.

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


- Subjects having more than 2 exacerbations requiring treatment with oral steroids or
hospitalization for the treatment of COPD in the previous year.


- History of lower respiratory tract infection or significant disease instability during
the month preceding screening or during the period between screening and
randomization.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
Official Title  ICMJE A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.
Brief Summary This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: PF-00610355
    dry powder inhaler, 1472 mcg, single dose
  • Drug: PF-00610355
    dry powder inhaler, 736 mcg, single dose
  • Drug: PF-00610355
    dry powder inhaler, 368 mcg, single dose
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: PF- 00610355
    Intervention: Drug: PF-00610355
  • Experimental: PF-00610355
    Intervention: Drug: PF-00610355
  • Experimental: PF -00610355
    Intervention: Drug: PF-00610355
  • 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
Estimated Enrollment  ICMJE
 (submitted: October 30, 2008)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Post-bronchodilator FEV1/ FVC ratio of <0.7.
  • Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
  • Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
  • Current smokers, or ex-smokers who have abstained from smoking for at least 6 months.

Exclusion Criteria:

  • Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
  • History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 80 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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00783406
Other Study ID Numbers  ICMJE A7881010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
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