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

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
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

- 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.

NCT00783406
Pfizer
Completed
Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.

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Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2009
March 2009   (Final data collection date for primary outcome measure)

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.
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
 
 
NCT00783406
A7881010
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2010

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

BY EMAIL

Contact

[email protected]



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