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| ID | Type | Description | Link |
|---|---|---|---|
| INHALED p38i COPD | |||
| 2014-002340-40 | EudraCT Number |
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Study terminated on 7 April 2015 for business reasons. No safety and/or efficacy concerns contributed to the termination of the study
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This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Double blind placebo for PF-03715455 |
|
| PF-03715455 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Orally inhaled placebo twice a day (BID) for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1), Day 29 (Week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 1 to Week 4 |
| Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicines Evaluation Unit Ltd | Wythenshawe | Manchester | M23 9QZ | United Kingdom | ||
| Nottingham University Hospital NHS Trust |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants were randomly assigned in a 1:1 ratio to receive either PF-03715455 680 micrograms (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.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-03715455 680 mcg Twice Daily | 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. |
| FG001 | Placebo | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
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| |||||||||||||||||||||
| Washout Period 28 to 49 Days |
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| Second Intervention Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who received at least 1 dose of study drug (PF-03715455 or placebo). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | liters | Baseline (Day 1), Day 29 (Week 4) |
|
Baseline up to follow-up period (Day 49)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-03715455 680 mcg Twice Daily | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA v18.0 | Non-systematic Assessment |
As this study was prematurely terminated by the sponsor for business reasons, no formal safety or efficacy conclusions can be drawn due to insufficient participant numbers. In addition, PK analysis was not conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C569762 | N-(1-(3-chloro-4-hydroxyphenyl)-3-(1,1-dimethylethyl)-1H-pyrazol-5-yl)-N'-((2-((3-(2-((2-hydroxyethyl)thio)phenyl)-1,2,4-triazolo(4,3-a)pyridin-6-yl)thio)phenyl)methyl)-urea |
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| PF-03715455 |
| Drug |
680 micrograms BID, Orally inhaled PF-03715455 for 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. FEV1 Baseline and Change at Week 4 are already reported under Primary Outcome Measure 1. |
| Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4) |
| 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. | Baseline, Week 1 to Week 4 |
| Maximum Observed Plasma Concentrations (Cmax) of PF-03715455 | Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29 |
| Trough Plasma Concentration (Ctrough) of PF-03715455 | Ctrough is the concentration prior to study drug administration. | Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29 |
| Baseline up to Day 29 (Week 4) |
| Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | 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. | Baseline up to Day 29 (Week 4) |
| Change From Baseline in Systolic and Diastolic Blood Pressure | Systolic blood pressure (SBP) and diastolic pressure (DBP) were evaluated in the supine position. | Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up) |
| Change From Baseline in Pulse Rate | Pulse rate was evaluated in the supine position. | Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up) |
| Number of Participants With Laboratory Abnormalities | 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]). | Baseline up to Week 4 |
| Nottingham |
| Nottinghamshire |
| NG5 1PB |
| United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2WB | United Kingdom |
| Heart of England NHS Foundation Trust | Birmingham | B9 5SS | United Kingdom |
| Respiratory Medicine, Bradford Institute of Health Research | Bradford | BD9 6RJ | United Kingdom |
| NOT COMPLETED |
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| NOT COMPLETED |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | 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. |
|
|
| Secondary | 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. | It was not meaningful to summarize sputum cell counts as there were too few participants in the sputum sub-study and, of those, too few adequate sputum specimens to be meaningfully summarized. | Posted | Baseline, Week 1 to Week 4 |
|
|
| Secondary | 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. | The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | liters | Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4) |
|
|
|
| Secondary | 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. | The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | liters | Baseline, Week 1 to Week 4 |
|
|
|
| Secondary | Maximum Observed Plasma Concentrations (Cmax) of PF-03715455 | As pharmacokinetics (PK) was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed. | Posted | Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29 |
|
|
| Secondary | Trough Plasma Concentration (Ctrough) of PF-03715455 | Ctrough is the concentration prior to study drug administration. | As PK was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed. | Posted | 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 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | The mITT analysis set included all randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline up to Day 29 (Week 4) |
|
|
|
| Other Pre-specified | Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings | 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. | The mITT analysis set included all randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline up to Day 29 (Week 4) |
|
|
|
| Other Pre-specified | Change From Baseline in Systolic and Diastolic Blood Pressure | Systolic blood pressure (SBP) and diastolic pressure (DBP) were evaluated in the supine position. | The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up) |
|
|
|
| Other Pre-specified | Change From Baseline in Pulse Rate | Pulse rate was evaluated in the supine position. | The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up) |
|
|
|
| Other Pre-specified | Number of Participants With Laboratory Abnormalities | 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]). | The mITT analysis set included all randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline up to Week 4 |
|
|
|
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Placebo | 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. | 0 | 7 | 4 | 7 |
| Dyspepsia | Gastrointestinal disorders | MedDRA v18.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v18.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v18.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v18.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v18.0 | Non-systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v18.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v18.0 | Non-systematic Assessment |
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| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA v18.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v18.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA v18.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| FVC: Baseline (n=8,7) |
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| FVC: Change at Week 1 (n=8,7) |
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| FVC: Change at Week 3 (n=8,7) |
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| FVC: Change at Week 4 (n=6,6) |
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| QT Interval >=500 msec |
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| QTcF Interval 450-<480 msec |
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| QTcF Interval 480-<500 msec |
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| QTcF Interval >=500 msec |
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| PR Interval >=25/50% Increase From Baseline |
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| QRS Complex >=25/50% Increase From Baseline |
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| QTcF Interval 30-<60 msec Increase From Baseline |
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| QTcF Interval >=60 msec Increase From Baseline |
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| SBP: Change at Week 3 (n=5,5) |
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| SBP: Change at Week 4 (n=8,7) |
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| SBP: Change at Follow-Up (n=7,6) |
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| DBP: Baseline (n=8,7) |
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| DBP: Change at Week 1 (n=7,6) |
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| DBP: Change at Week 3 (n=5,5) |
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| DBP: Change at Week 4 (n=8,7) |
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| DBP: Change at Follow-Up (n=7,6) |
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| Change at Week 3 (n=5,5) |
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| Change at Week 4 (n=8,7) |
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| Change at Follow-Up (n=7,6) |
|