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

NCT02366637

Last updated date
Study Location
Medicines Evaluation Unit Ltd
Wythenshawe, Manchester, M23 9QZ, United Kingdom
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease
Official Title  ICMJE 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)
Brief Summary This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Double blind placebo for PF-03715455
    Intervention: Drug: Placebo
  • Experimental: PF-03715455
    Intervention: Drug: PF-03715455
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 7, 2016)
13
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2015)
80
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02366637
Other Study ID Numbers  ICMJE A9111004
INHALED p38i COPD
2014-002340-40 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP