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An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease

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NCT02366637

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Medicines Evaluation Unit Ltd
Wythenshawe, Manchester, M23 9QZ United Kingdom
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

- Female subjects of non-childbearing potential and male subjects between the ages of 40
and 80 years, inclusive

- Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD and who
meet the criteria for Stage II-III disease

- Subjects must have a smoking history of at least 10 pack-years

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Current evidence or history within the previous 6 months of any clinically significant
disease (other than COPD) or abnormality in the opinion of the Investigator that would
put the subject at risk or which would compromise the quality of the study data

- A COPD exacerbation requiring treatment with oral steroids or hospitalization for the
treatment of COPD within 3 months of Screening

NCT02366637
Pfizer
Terminated
An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease

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An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease
A Randomized, Double-blind, Placebo-controlled 2-way Crossover Study To Evaluate The Efficacy, Safety And Tolerability Of Pf-03715455 Administered Twice Daily By Inhalation For 4 Weeks In Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease (Copd)
This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Placebo
    Orally inhaled placebo twice a day (BID) for 4 weeks
  • Drug: PF-03715455
    680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks
  • Placebo Comparator: Placebo
    Double blind placebo for PF-03715455
    Intervention: Drug: Placebo
  • Experimental: PF-03715455
    Intervention: Drug: PF-03715455
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
May 2015
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female subjects of non-childbearing potential and male subjects between the ages of 40 and 80 years, inclusive
  • Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD and who meet the criteria for Stage II-III disease
  • Subjects must have a smoking history of at least 10 pack-years

Exclusion Criteria:

  • Current evidence or history within the previous 6 months of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data
  • A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of Screening
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT02366637
A9111004
INHALED p38i COPD
2014-002340-40 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 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.

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1-800-718-1021

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