Back to resultsAn Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
PF-03715455
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, Sputum
Eligibility Criteria
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
Sites / Locations
- Medicines Evaluation Unit Ltd
- Nottingham University Hospital NHS Trust
- University Hospitals Birmingham NHS Foundation Trust
- Heart of England NHS Foundation Trust
- Respiratory Medicine, Bradford Institute of Health Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
PF-03715455
Arm Description
Double blind placebo for PF-03715455
Outcomes
Primary Outcome Measures
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
Secondary Outcome Measures
Change From Baseline in Sputum Cell Counts Over 4 Weeks
Sputum cell counts included total neutrophils counts and differential (percent [%]), total cell count, total macrophage count and differential (%). Change over 4 weeks was to be presented.
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 Baseline and Change at Week 4 are already reported under Primary Outcome Measure 1.
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change over 4 weeks is presented.
Maximum Observed Plasma Concentrations (Cmax) of PF-03715455
Trough Plasma Concentration (Ctrough) of PF-03715455
Ctrough is the concentration prior to study drug administration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02366637
Brief Title
An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Study terminated on 7 April 2015 for business reasons. No safety and/or efficacy concerns contributed to the termination of the study
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD, Sputum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Double blind placebo for PF-03715455
Arm Title
PF-03715455
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally inhaled placebo twice a day (BID) for 4 weeks
Intervention Type
Drug
Intervention Name(s)
PF-03715455
Intervention Description
680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
Description
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
Time Frame
Baseline (Day 1), Day 29 (Week 4)
Secondary Outcome Measure Information:
Title
Change From Baseline in Sputum Cell Counts Over 4 Weeks
Description
Sputum cell counts included total neutrophils counts and differential (percent [%]), total cell count, total macrophage count and differential (%). Change over 4 weeks was to be presented.
Time Frame
Baseline, Week 1 to Week 4
Title
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4
Description
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 Baseline and Change at Week 4 are already reported under Primary Outcome Measure 1.
Time Frame
Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)
Title
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks
Description
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change over 4 weeks is presented.
Time Frame
Baseline, Week 1 to Week 4
Title
Maximum Observed Plasma Concentrations (Cmax) of PF-03715455
Time Frame
Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29
Title
Trough Plasma Concentration (Ctrough) of PF-03715455
Description
Ctrough is the concentration prior to study drug administration.
Time Frame
Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time Frame
Baseline up to Day 29 (Week 4)
Title
Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings
Description
Clinically significant ECG findings include: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to 200 msec; QRS interval >=200 msec or >=25/50% increase from baseline; QT interval >=500 msec; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.
Time Frame
Baseline up to Day 29 (Week 4)
Title
Change From Baseline in Systolic and Diastolic Blood Pressure
Description
Systolic blood pressure (SBP) and diastolic pressure (DBP) were evaluated in the supine position.
Time Frame
Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)
Title
Change From Baseline in Pulse Rate
Description
Pulse rate was evaluated in the supine position.
Time Frame
Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)
Title
Number of Participants With Laboratory Abnormalities
Description
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct and indirect bilirubin, gamma-glutamyl transpeptidase [GGT], alkaline phosphatase, uric acid, albumin, total protein, high sensitivity C-reactive protein [CRP]); urinalysis (specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [only if urine dipstick was positive for blood or protein]).
Time Frame
Baseline up to Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Medicines Evaluation Unit Ltd
City
Wythenshawe
State/Province
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
Facility Name
Nottingham University Hospital NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2WB
Country
United Kingdom
Facility Name
Heart of England NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Respiratory Medicine, Bradford Institute of Health Research
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9111004&StudyName=An%20Evaluation%20Of%20PF-03715455%20In%20Moderate%20To%20Severe%20Chronic%20Obstructive%20Pulmonary%20Disease
Description
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Learn more about this trial
An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease
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