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A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Fairhope, Alabama, 36532 United States
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, Obstructive Lung Diseases
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

- Diagnosis of moderate COPD for a minimum of 6 months.

- 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 requiring treatment with oral steroids in the
preceding year or hospitalisation for the treatment of COPD within 3 months of
screening or more than twice during the preceding year.

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

NCT00808288
Pfizer
Completed
A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.

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A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.
A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease.
To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases
  • Lung Diseases, Obstructive
  • Drug: PF-00610355
    oral, inhaled, dry powder, 600ug, OD
  • Drug: PF - 00610355
    oral, inhaled, dry powder, 300ug, OD
  • Drug: PF- 00610355
    oral, inhaled, dry powder, 100ug, OD
  • Drug: Placebo
    oral, inhaled, dry powder, placebo, OD
  • Drug: Salmeterol
    salmeterol, 50ug, BID
  • 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
  • Active Comparator: Salmeterol
    Intervention: Drug: Salmeterol
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
405
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%.
  • Diagnosis of moderate COPD for a minimum of 6 months.
  • Stable disease for at least 1 month prior to screening

Exclusion Criteria:

  • More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
  • History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Bulgaria,   Croatia,   Czech Republic,   Germany,   Hungary,   Poland,   Slovakia,   South Africa,   Spain,   Turkey,   United States
 
 
NCT00808288
A7881013
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

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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