A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance Therapy
NCT ID: NCT02238483
Last Updated: 2018-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
213 participants
INTERVENTIONAL
2014-10-28
2016-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZD7624
Active treatment
AZD7624 1.0 mg
Inhaled AZD7624 solution, 11 mg/mL
Placebo
Placebo Comparator
Placebo
Inhaled placebo solution
Interventions
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AZD7624 1.0 mg
Inhaled AZD7624 solution, 11 mg/mL
Placebo
Inhaled placebo solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
* History or family history of muscle diseases. Abnormal vital signs, defined as Systolic Blood Pressure (SBP) above 140 mmHg if \<60 years of age and above 150 mmHg if ≥60 years of age; Diastolic Blood Pressure (DBP) above 90 mmHg; Pulse \<50 or \>100 bpm.
* Prolonged QTcF \>450 ms or family history of long QT syndrome or sudden death at young age. PR(PQ) interval of clinical significance, PR(PQ) \> 250 ms.
* Intermittent AV block of 2nd and 3rd degree or AV dissociation.
* Patients with a QRS duration \>120 ms.
* Patients with persistent, and/or recurrent symptomatic tachyarrhythmias, as well as patients with an implantable cardioverter-defibrillator (ICD) or a permanent pacemaker.
* Patients with recent Cardiovascular (CV) events or unstable CV disease or a myocardial infarction or stroke within 6 months of screening. History of hospitalization within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association (NYHA) class II.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624.
* Any exacerbation or respiratory infection within 6 weeks of randomization.
* Plasma donation within one month of Visit 1, or any blood donation/blood loss \>500 mL during the 3 months prior to Visit 1.
* History of, or current alcohol or drug abuse.
* Treatment with any GCS (apart from prescribed steroids at run-in) within 6 weeks of Visit 3 regardless of indication.
* Treatment with strong CYP3A inhibitors within 4 weeks prior to randomisation.
40 Years
85 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Naimish Patel, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca R&D Boston
Barry Make, MD, FCCP, FACVPR
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health, Denver, United States
Locations
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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
Research Site
Larchmont, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Wilmington, North Carolina, United States
Research Site
Akron, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Erie, Pennsylvania, United States
Research Site
Gaffney, South Carolina, United States
Research Site
Greenville, South Carolina, United States
Research Site
Rock Hill, South Carolina, United States
Research Site
Kingwood, Texas, United States
Research Site
Buenos Aires, , Argentina
Research Site
CABA, , Argentina
Research Site
Ciudad Autónoma de Bs. As., , Argentina
Research Site
Quilmes, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Talca, , Chile
Research Site
Talcahuano, , Chile
Research Site
Assen, , Netherlands
Research Site
Heerlen, , Netherlands
Research Site
Nijmegen, , Netherlands
Research Site
Zutphen, , Netherlands
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Cape Town, , South Africa
Research Site
eManzimtoti, , South Africa
Research Site
Johannesburg, , South Africa
Research Site
Johannesburg, , South Africa
Research Site
Mount Edgecombe, , South Africa
Research Site
Parktown West, , South Africa
Countries
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Other Identifiers
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2014-001053-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D2550C00005
Identifier Type: -
Identifier Source: org_study_id
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