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

NCT02238483 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: D2550C000052014-001053-16
• Study Type: interventional
• Target: 213
• Locations: 6 countries
• Sites: 41

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease COPD

Keywords

Chronic Obstructive Pulmonary Disease; COPD patients; Exacerbations; ICS; LABA

Outcome Measures

Primary Outcomes (1)

• Time to First Moderate to Severe COPD Exacerbation or Early Drop-out Related to Worsening of COPD Symptoms

  Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

Secondary Outcomes (15)

• Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs Related to Worsening of COPD Symptoms (i.e. Composite Endpoint, ExDo)

  Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

• Time to First Event of Moderate or Severe COPD Exacerbations or Early Drop-out (Including Drop-outs Due to Any Cause)

  Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

• Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs (Including Drop-outs Due to Any Cause)

  Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

• Time to First Moderate or Severe Exacerbation

  Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

• Annual Exacerbation Rate of Moderate and Severe Exacerbations

  Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

Study Arms (2)

AZD7624

EXPERIMENTAL

Active treatment

Drug: AZD7624 1.0 mg

Placebo

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo

Interventions

AZD7624 1.0 mg DRUG

Inhaled AZD7624 solution, 11 mg/mL

AZD7624

Placebo DRUG

Inhaled placebo solution

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (41)

Research Site

Los Angeles, California, 90036, United States

Location

Research Site

Torrance, California, 90505, United States

Location

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Denver, Colorado, 80206, United States

Location

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Hialeah, Florida, 33013, United States

Location

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Miami, Florida, 33176, United States

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Pembroke Pines, Florida, 33024, United States

Location

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Atlanta, Georgia, 30310, United States

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Blue Ridge, Georgia, 30513, United States

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Baltimore, Maryland, 21224, United States

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St Louis, Missouri, 63141, United States

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Larchmont, New York, 10538, United States

Location

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Charlotte, North Carolina, 28207, United States

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Wilmington, North Carolina, 28401, United States

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Akron, Ohio, 44302, United States

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Dayton, Ohio, 45459, United States

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Erie, Pennsylvania, 16508, United States

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Gaffney, South Carolina, 29340, United States

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Greenville, South Carolina, 29605, United States

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Rock Hill, South Carolina, 29732, United States

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Kingwood, Texas, 77339, United States

Location

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Buenos Aires, C1414AIF, Argentina

Location

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CABA, C1425BEN, Argentina

Location

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Ciudad Autónoma de Bs. As., 1426, Argentina

Location

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Quilmes, B1878FNR, Argentina

Location

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San Miguel de Tucumán, 4000, Argentina

Location

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Santiago, 7980378, Chile

Location

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Santiago, 8380453, Chile

Location

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Talca, 3465584, Chile

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Talcahuano, 4270918, Chile

Location

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Assen, 9401 RK, Netherlands

Location

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Heerlen, 6419 PC, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Zutphen, 7207 AE, Netherlands

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Lima, L 41, Peru

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Lima, LIMA 21, Peru

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Cape Town, 7764, South Africa

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eManzimtoti, 4126, South Africa

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Johannesburg, 1818, South Africa

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Johannesburg, 2001, South Africa

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Mount Edgecombe, 4302, South Africa

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Parktown West, 2193, South Africa

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

AZD7624

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ziad Taib
• Organization: AstraZeneca

ziad.taib@astrazeneca.com

+46 708 46 73 56

Study Officials

• Naimish Patel, MD, PhD

  AstraZeneca R&D Boston

  STUDY DIRECTOR

• Barry Make, MD, FCCP, FACVPR

  National Jewish Health, Denver, United States

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: September 12, 2014
• Study Start: October 28, 2014
• Primary Completion: April 4, 2016
• Study Completion: April 4, 2016
• Last Updated: May 24, 2018
• Results First Posted: April 18, 2018

Record last verified: 2018-04

Locations

AR (5); US (20); CL (4); NL (4); PE (2); ZA (6)