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

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NCT00430300

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Camperdown, New South Wales, 2050 Australia
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT00430300
Pfizer
Terminated
Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.

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Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.
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.
Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
87
July 2008
July 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Netherlands,   Poland,   United Kingdom
 
 
NCT00430300
A3971013
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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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[email protected]



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