Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.

NCT00430300

Last updated date
Study Location
Pfizer Investigational Site
Camperdown, New South Wales, 2050, Australia
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

- Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease

- Patients must have a smoking history of at least 10 pack-years

- Patients must have stable disease for at least 1 month prior to screening.

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


- More than 2 exacerbations of COPD in the preceding year


- History of a lower respiratory tract infection or significant disease instability
during the month proceding screening or during the time between screen and
randomization.


- History or presence of respiratory failure, cor pulmonale or right ventricular failure

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.
Official Title  ICMJE A Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group Study To Evaluate the Efficacy And Safety of UK-432,097 Dry Powder For Inhalation In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease.
Brief Summary Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: UK-432,097
    Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.
  • Drug: Placebo
    Capsules containing 100% lactose administered BID using an atomizer device
Study Arms  ICMJE
  • Experimental: 150mcg, 450mcg or 1350mcg
    Active treatment given BID via a double pin monodose capsule inhaler device
    Intervention: Drug: UK-432,097
  • Placebo Comparator: Placebo
    Placebo treatment given BID via a single pin monodose inhaler device
    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 Terminated
Actual Enrollment  ICMJE
 (submitted: February 20, 2013)
87
Original Enrollment  ICMJE
 (submitted: January 31, 2007)
240
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease
  • Patients must have a smoking history of at least 10 pack-years
  • Patients must have stable disease for at least 1 month prior to screening.

Exclusion Criteria:

  • More than 2 exacerbations of COPD in the preceding year
  • History of a lower respiratory tract infection or significant disease instability during the month proceding screening or during the time between screen and randomization.
  • History or presence of respiratory failure, cor pulmonale or right ventricular failure
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 Australia,   Canada,   Netherlands,   Poland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00430300
Other Study ID Numbers  ICMJE A3971013
Has Data Monitoring Committee Yes
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 May 2013

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