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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02366637
• Other study ID #: A9111004
• Secondary ID: INHALED p38i COP
• Status: Terminated
• Phase: Phase 2
• First received: September 2, 2014
• Last updated: January 7, 2016
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Placebo
Orally inhaled placebo twice a day (BID) for 4 weeks
• PF-03715455
680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks

Locations

Country	Name	City	State
United Kingdom	Heart of England NHS Foundation Trust	Birmingham
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Respiratory Medicine, Bradford Institute of Health Research	Bradford
United Kingdom	Nottingham University Hospital NHS Trust	Nottingham	Nottinghamshire
United Kingdom	Medicines Evaluation Unit Ltd	Wythenshawe	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in trough forced expiratory volume in 1 second (FEV1) at Week 4		Baseline, Week 4	No
Secondary	Change from baseline in sputum cell counts over 4 weeks		Baseline, Week 4	No
Secondary	Change from baseline in trough forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) averaged over 4 weeks and at individual study visits		Baseline, Weeks 1, 3 and 4	No
Secondary	Summary Pharmacokinetics - Cmax		Weeks 1, 3 and 4	No
Secondary	Summary Pharmacokinetics - Ctrough		Weeks 1, 3 and 4	No

External Links

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