A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance Therapy

A 12-week Phase IIa, Double-blind, Placebo-controlled, Randomized Study to Investigate the Efficacy and Safety of AZD7624 in COPD Patients With a History of Frequent Acute Exacerbations While on Maintenance Therapy

NCT02238483•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether AZD7624 can reduce acute Chronic Obstructive Pulmonary Disease (COPD) exacerbations in patients on COPD maintenance therapy with a history of frequent acute exacerbations.

Eligibility

Age

40 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated written informed consent prior to any study specific procedures.
•Male and females aged 40-85 years. Females must have a negative pregnancy test at Visit 1, must not be lactating and must be of non-childbearing potential. Males must be surgically sterile or agree to use an acceptable method of contraception for the duration of the study and for 3 months after the last dose of investigational product to prevent pregnancy in a partner.
•A weight of ≥50 kg.
•Diagnosis of COPD for more than 1 year at Visit 1, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines.
•COPD maintenance treatment with at least ICS/LABA for at least 2 months prior to enrolment to be continued unchanged during the study.
•A post-bronchodilator FEV1/FVC \<0.70 and a post-bronchodilator FEV1 ≤70% of the predicted normal value. Documented history of 2 or more moderate to severe COPD exacerbations within 12 months of randomisation, but not within the last 6 weeks before randomisation.
•Current or ex-smokers with a smoking history of at least 10 pack-years.

Exclusion Criteria

•Involvement in the planning and conduct of the study.
•Previous randomisation in the present study.
•Participation in another clinical study with any investigational medicinal product within 3 months of randomisation. Previously intake of any p38 inhibitor.
•Participation in, or scheduled for an intensive COPD rehabilitation programme at any time during the study.
•Planned in-patient surgery or hospitalisation during the study.
•Significant disease or disorder other than COPD which, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines (GINA 2013) or other accepted guidelines.
•A clinically relevant abnormal findings in clinical chemistry, haematology and urinalysis.
•Plasma myoglobin and CK above the upper reference range of the analysing laboratory at randomization.
•A clinically relevant abnormal findings in physical examination, pulse or blood pressure.
•A positive result on screening for serum hepatitis B hepatitis C and Human Immunodeficiency Virus (HIV).
+12 more criteria

Locations (41)

Research Site

Los Angeles, California, United States

Research Site

Torrance, California, United States

Research Site

Denver, Colorado, United States

Research Site

Hialeah, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Pembroke Pines, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Blue Ridge, Georgia, United States

Research Site

Baltimore, Maryland, United States

Research Site

St Louis, Missouri, United States

Key Dates

Start Date

October 28, 2014

Primary Completion Date

April 4, 2016

Completion Date

April 4, 2016

Last Updated

May 24, 2018

Enrollment

213

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease COPD

Interventions

AZD7624 1.0 mg

DRUG

Placebo

DRUG