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    Clinical Trial Results:
    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)

    Summary
    EudraCT number
    		 2014-002340-40
    Trial protocol
    		 GB  
    Global end of trial date
    01 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Apr 2016
    First version publication date
    23 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A9111004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 May 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective was to determine the effect, at Week 4, of orally inhlaed PF-03715455 680 mcg twice daily on trough forced expiratory volume in 1 second (FEV1) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) on a stable regimen of short or long acting bronchodilators.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jan 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    7
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were randomly assigned in a 1:1 ratio to receive either PF-03715455 680 mcg twice daily for 4 weeks or matching placebo in Period 1. Participants who were randomized to PF-03715455 during Period 1 then received placebo for 4 weeks during Period 2 after a 28 to 49-day washout period, and vice versa.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 PF-03715455 680 mcg Twice Daily
    Arm description
    		 PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-03715455
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    inhaled orally twice daily

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    inhaled orally twice daily

    Number of subjects in period 1
    		PF-03715455 680 mcg Twice Daily Placebo
    Started
    8
    7
    Completed
    1
    1
    Not completed
    7
    6
         Adverse event, non-fatal
    -
    1
         Study terminated by sponsor
    7
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 7 7
        From 65-84 years
    		 6 6
        85 years and over
    		 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 62 ( 6.5 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 8 8
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    PF-03715455 680 mcg Twice Daily
    Reporting group description
    		 PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.

    Primary: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4

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    End point title
    		 Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4 [1]
    End point 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.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), Day 29 (Week 4)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were not planned and were not performed due to the limited number of subjects.
    End point values
    		 PF-03715455 680 mcg Twice Daily Placebo
    Number of subjects analysed
    8
    7
    Units: liters
    arithmetic mean (standard deviation)
        Baseline (n=8,7)
    1.368 ( 0.3534 )
    1.456 ( 0.5209 )
        Change at Week 4 (n=6,6)
    -0.047 ( 0.0983 )
    0.08 ( 0.231 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Sputum Cell Counts

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    End point title
    		 Change From Baseline in Sputum Cell Counts
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)
    End point values
    		 PF-03715455 680 mcg Twice Daily Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: cells
    Notes
    [2] - As the study was prematurely terminated, efficacy analyses were not performed.
    [3] - As the study was prematurely terminated, efficacy analyses were not performed.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4

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    End point title
    		 Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4
    End point 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.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)
    End point values
    		 PF-03715455 680 mcg Twice Daily Placebo
    Number of subjects analysed
    8
    7
    Units: liters
    arithmetic mean (standard deviation)
        FEV1: Change at Week 1 (n=8,7)
    -0.065 ( 0.1231 )
    -0.001 ( 0.2559 )
        FEV1: Change at Week 3 (n=8,7)
    -0.039 ( 0.2194 )
    -0.026 ( 0.1033 )
        FVC: Baseline (n=8,7)
    2.535 ( 0.8639 )
    3.263 ( 1.2571 )
        FVC: Change at Week 1 (n=8,7)
    -0.019 ( 0.1336 )
    0.09 ( 0.163 )
        FVC: Change at Week 3 (n=8,7)
    0.049 ( 0.21 )
    -0.079 ( 0.1893 )
        FVC: Change at Week 4 (n=6,6)
    0.091 ( 0.1661 )
    0.233 ( 0.3014 )
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentrations (Cmax) of PF-03715455

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    End point title
    		 Maximum Observed Plasma Concentrations (Cmax) of PF-03715455
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)
    End point values
    		 PF-03715455 680 mcg Twice Daily Placebo
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: nanogram per milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    Notes
    [4] - As the study was prematurely terminated, PK analysis was not conducted.
    [5] - As the study was prematurely terminated, PK analysis was not conducted.
    No statistical analyses for this end point

    Secondary: Trough Plasma Concentration (Ctrough) of PF-03715455

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    End point title
    		 Trough Plasma Concentration (Ctrough) of PF-03715455
    End point description
    Ctrough is the concentration prior to study drug administration.
    End point type
    Secondary
    End point timeframe
    Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)
    End point values
    		 PF-03715455 680 mcg Twice Daily Placebo
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    Notes
    [6] - As the study was prematurely terminated, PK analysis was not conducted.
    [7] - As the study was prematurely terminated, PK analysis was not conducted.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks

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    End point title
    		 Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks
    End point 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.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1 to Week 4
    End point values
    		 PF-03715455 680 mcg Twice Daily Placebo
    Number of subjects analysed
    8
    7
    Units: liters
    arithmetic mean (standard deviation)
        FEV1: Change Over 4 Weeks (n=6,6)
    -0.047 ( 0.0983 )
    0.08 ( 0.231 )
        FVC: Change Over 4 Weeks (n=6,6)
    0.091 ( 0.1661 )
    0.233 ( 0.3014 )
    No statistical analyses for this end point

    Other pre-specified: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in a participant who received study drug. 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 49 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Day 29 (Week 4)
    End point values
    		 PF-03715455 680 mcg Twice Daily Placebo
    Number of subjects analysed
    8
    7
    Units: participants
        AEs
    3
    4
        SAEs
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Participants with Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings

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    End point title
    		 Number of Participants with Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings
    End point 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.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Day 29 (Week 4)
    End point values
    		 PF-03715455 680 mcg Twice Daily Placebo
    Number of subjects analysed
    8
    7
    Units: participants
        PR Interval >=300 msec
    0
    0
        QRS Complex >=200 msec
    0
    0
        QT Interval >=500 msec
    0
    0
        QTcF Interval 450-<480 msec
    0
    0
        QTcF Interval 480-<500 msec
    0
    0
        QTcF Interval >=500 msec
    0
    0
        PR Interval >=25/50% Increase From Baseline
    0
    0
        QRS Complex >=25/50% Increase From Baseline
    0
    0
        QTcF Interval 30-<60 msec Increase From Baseline
    0
    0
        QTcF Interval >=60 msec Increase From Baseline
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Systolic and Diastolic Blood Pressure

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    End point title
    		 Change From Baseline in Systolic and Diastolic Blood Pressure
    End point description
    Systolic blood pressure (SBP) and diastolic pressure (DBP) were evaluated in the supine position.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)
    End point values
    		 PF-03715455 680 mcg Twice Daily Placebo
    Number of subjects analysed
    8
    7
    Units: millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        SBP: Baseline (n=8,7)
    130 ( 19.16 )
    122.7 ( 13.92 )
        SBP: Change at Week 1 (n=7,6)
    -7.4 ( 13.24 )
    1.3 ( 3.01 )
        SBP: Change at Week 3 (n=5,5)
    -3.4 ( 12.03 )
    -0.6 ( 9.02 )
        SBP: Change at Week 4 (n=8,7)
    -2 ( 15.34 )
    8.1 ( 7.06 )
        SBP: Change at Follow-Up (n=7,6)
    1.4 ( 13.49 )
    4.7 ( 11.24 )
        DBP: Baseline (n=8,7)
    69.9 ( 9.72 )
    65.1 ( 9.01 )
        DBP: Change at Week 1 (n=7,6)
    0.6 ( 6.95 )
    8.7 ( 8.69 )
        DBP: Change at Week 3 (n=5,5)
    2.4 ( 7.09 )
    4.4 ( 5.13 )
        DBP: Change at Week 4 (n=8,7)
    2.1 ( 3.91 )
    2.4 ( 8.46 )
        DBP: Change at Follow-Up (n=7,6)
    5.4 ( 6.63 )
    2.8 ( 5.04 )
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Pulse Rate

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    End point title
    		 Change From Baseline in Pulse Rate
    End point description
    Pulse rate was evaluated in the supine position.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)
    End point values
    		 PF-03715455 680 mcg Twice Daily Placebo
    Number of subjects analysed
    8
    7
    Units: beats per minute (bpm)
    arithmetic mean (standard deviation)
        Baseline (n=8,7)
    66.5 ( 11.82 )
    64.3 ( 9.71 )
        Change at Week 1 (n=7,6)
    3.6 ( 7.41 )
    3.5 ( 3.56 )
        Change at Week 3 (n=5,5)
    -1.6 ( 3.36 )
    0 ( 3.16 )
        Change at Week 4 (n=8,7)
    1.3 ( 2.93 )
    1.3 ( 6.24 )
        Change at Follow-Up (n=7,6)
    2 ( 4.76 )
    1 ( 3.35 )
    No statistical analyses for this end point

    Other pre-specified: Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern

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    End point title
    		 Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
    End point 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]).
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 4
    End point values
    		 PF-03715455 680 mcg Twice Daily Placebo
    Number of subjects analysed
    8
    7
    Units: participants
    6
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to follow-up period (Day 49)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.

    Reporting group title
    PF-03715455 680 mcg Twice Daily
    Reporting group description
    		 PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.

    Serious adverse events
    		 Placebo PF-03715455 680 mcg Twice Daily
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo PF-03715455 680 mcg Twice Daily
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 7 (57.14%)
    3 / 8 (37.50%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Haemarthrosis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    As this study was prematurely terminated by the sponsor, no formal safety or efficacy conclusions can be drawn due to insufficient participant numbers. In addition, PK analysis was not conducted.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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