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A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Berlin, , 10117 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Respiratory Tract Diseases, Chronic Obstructive Airway Disease, COPD
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

- Male or female (women of non-childbearing potential) subjects between the ages of 40
and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who
meet the following criteria for GOLD stage II disease

- Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88
lbs).

- 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.

NCT01033487
Pfizer
Completed
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease

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Pfizer Clinical Trials Contact Center

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[email protected]

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A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
A Phase 2A, Double Blind, Placebo-Controlled, Single Dose, 5-Way Crossover Study Assessing The Pharmacodynamic, Pharmacokinetic And Safety Profiles Of Oral Inhaled PF-03635659 In Patients With Moderate Chronic Obstructive Pulmonary Disease.
PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases
  • Respiratory Tract Diseases
  • Chronic Obstructive Airway Disease
  • COPD
  • Drug: placebo
    oral inhaled formulation, single dose
  • Drug: active comparator
    oral inhaled formulation, single dose
  • Drug: Low Dose PF-03635659
    oral inhaled formulation, single dose, low dose
  • Drug: Mid Dose PF-03635659
    oral inhaled formulation, single dose, mid dose
  • Drug: High Dose PF-03635659
    oral inhaled formulation, single dose, high dose
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Active Comparator: active comparator
    Intervention: Drug: active comparator
  • Experimental: PF-03635659
    Interventions:
    • Drug: Low Dose PF-03635659
    • Drug: Mid Dose PF-03635659
    • Drug: High Dose PF-03635659
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
  • Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88 lbs).
  • 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.
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01033487
B0431010
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2016

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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