AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)

NCT01215279 | Completed Phase 2 Results

• 1 other identifier: D3320C00002
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 6

Brief Summary

The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease.

Conditions

Chronic Obstructive Pulmonary Disease; Lung Disease

Keywords

Respiratory disease; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes

  Number of all participants with clinically significant changes in laboratory variables, except monocyte, assessed at all the listed time points

  Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

• Number of Participants With Clinically Significant Changes in Vital Signs

  Number of participants with clinically significant changes in vital signs assessed at all the listed time points

  Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

• Number of Participants With Clinically Significant Changes in ECG Variables

  Number of participants with clinically significant changes in ECG variables assessed at all the listed time points

  Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

• Number of Participants With Clinically Significant Changes in Physical Examination

  Number of participants with clinically significant changes in physical examination assessed at all the listed time points

  Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)

• Monocytes at Baseline

  Monocyte count in peripheral blood at baseline (Pre-dose, Day 1)

  Day 1

• Monocytes at End of Treatment

  Monocyte count in peripheral blood at end of treatment (4 weeks)

  week 4

• Monocytes at Follow-up

  Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment)

  week 5 (follow-up)

Secondary Outcomes (23)

• Morning FEV1 at Baseline

  Average of 10 days of pre-treatment measurements (day -10 to -1)

• Morning FEV1 During Last 7 Days of Treatment

  Average of the last 7 days of treatment (week 4)

• Evening FEV1 at Baseline

  Average of 10 days of pre-treatment measurements (day -10 to -1)

• Evening FEV1 During Last 7 Days of Treatment

  Average of the last 7 days of treatment (week 4)

• Morning Peak Expiratory Flow (PEF) at Baseline

  Average of 10 days of pre-treatment measurements (day -10 to -1)

Study Arms (2)

AZD2423

EXPERIMENTAL

AZD2423 Oral Treatment for 28 days

Drug: AZD2423

Placebo

PLACEBO COMPARATOR

Oral treatment for 28 days

Drug: Placebo to AZD2423

Interventions

AZD2423 DRUG

100 mg oral treatment once daily for 28 days

AZD2423

Placebo to AZD2423 DRUG

Oral treatment once daily for 28 days

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female of non-child bearing potential. Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
• Between 40 and 80 years of age at Visit 1
• Clinical diagnosis of COPD (GOLD stage 2 or 3)
• FEV1/FVC \<70% and FEV1 between 30 and 80% of the predicted normal post-bronchodilator (GOLD stage 2 or 3)
• Current or ex-smokers

You may not qualify if:

• Any clinically significant disease or disorder (including history of abnormal immune function) which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
• Any lung disease other than COPD, recent respiratory infections which have not resolved fully, active tuberculosis or at risk of reactivation of tuberculosis.
• Any abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability to take part or influence the results of the study
• Immunisation with a live vaccine within 3 months or other vaccination within 30 days before planned start of treatment
• Worsening of COPD symptoms within 4 weeks prior to start of study needing hospitalisation, oral steroids or antibiotics.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Rousse, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Bratislava, Slovakia

Location

Research Site

Košice, Slovakia

Location

Research Site

Prešov, Slovakia

Location

Research Site

Žilina, Slovakia

Location

Related Links

• CSR-D3320C00002.pdf

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiration Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Anna Malmgren
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Joanna Marks-Konczalik, MD, PhD

  AstraZeneca R&D

  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: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 6, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 23, 2014
• Results First Posted: October 23, 2014

Record last verified: 2014-10

Locations

BU (2); SL (4)