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

NCT02366637 | Terminated Phase 2 Results DMC

• 3 other identifiers: A9111004INHALED p38i COPD2014-002340-40
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 5

Brief Summary

This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; Sputum

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Change From Baseline in Sputum Cell Counts Over 4 Weeks

  Baseline, Week 1 to Week 4

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

  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

  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

  Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29

Other Outcomes (5)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to Day 29 (Week 4)

• Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings

  Baseline up to Day 29 (Week 4)

• Change From Baseline in Systolic and Diastolic Blood Pressure

  Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Double blind placebo for PF-03715455

Drug: Placebo

PF-03715455

EXPERIMENTAL

Drug: PF-03715455

Interventions

Placebo DRUG

Orally inhaled placebo twice a day (BID) for 4 weeks

Placebo

PF-03715455 DRUG

680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks

PF-03715455

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Medicines Evaluation Unit Ltd

Wythenshawe, Manchester, M23 9QZ, United Kingdom

Location

Nottingham University Hospital NHS Trust

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2WB, United Kingdom

Location

Heart of England NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

Location

Respiratory Medicine, Bradford Institute of Health Research

Bradford, BD9 6RJ, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

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

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: February 19, 2015
• Study Start: January 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 6, 2016
• Results First Posted: July 6, 2016

Record last verified: 2016-05

Locations

GB (5)