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Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients. (A7881010)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00783406
First received: October 30, 2008
Last updated: October 27, 2010
Last verified: October 2010
History of Changes

October 30, 2008
October 27, 2010
October 2008
March 2009   (final data collection date for primary outcome measure)
  • To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients. [ Time Frame: up to 8 days post dose ] [ Designated as safety issue: Yes ]
  • To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients [ Time Frame: up to 24 hours post dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00783406 on ClinicalTrials.gov Archive Site
  • To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients. [ Time Frame: up to 24 hours post dose ] [ Designated as safety issue: Yes ]
  • To investigate the exposure/response relationship of PF-00610355. [ Time Frame: up to 8 days post dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00783406
A7881010
No
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