Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)

NCT01153321 | Completed Phase 2 Results

• 2 other identifiers: D3320C000012010-020141-26
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.

Conditions

Chronic Obstructive Pulmonary Disease; Lung Disease

Keywords

Respiratory disease; chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Absolute Monocyte Count in BAL Post-LPS Challenge

  Monocyte count in BAL post-LPS challenge (Day 11)

  Day 11

Secondary Outcomes (53)

• Total Neutrophils in Biopsy Sample (Post-LPS Challenge)

  Day 11

• Total Macrophages in Biopsy Sample (Post-LPS Challenge)

  Day 11

• CD45+ in Biopsy Sample (Post-LPS Challenge)

  Day 11

• CD3+ in Biopsy Sample (Post-LPS Challenge)

  Day 11

• Biopsy PAS Reaction Grade (Post-LPS Challenge)

  Day 11

Study Arms (2)

1

EXPERIMENTAL

Oral treatment

Drug: AZD2423

2

PLACEBO COMPARATOR

Oral treatment

Drug: AZD2423 Placebo

Interventions

AZD2423 DRUG

100mg Oral dose od

1

AZD2423 Placebo DRUG

Oral dose od

2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
• Any clinically relevant 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 or take part or influence the results of the study
• A past history or current indication of renal (kidney) failure
• Subjects at risk of active tuberculosis or of disease reactivation
• Subjects who have had any clinically significant illness within 4 weeks before Visit 2 (start of treatment)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Hanover, Hannover, Germany

Location

Related Links

• D3320C00001 Clinical Study Report Synopsis
• D3320C00001 CSR Synopsis

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

• Bengt Larsson

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 10, 2015
• Results First Posted: October 23, 2014

Record last verified: 2015-03

Locations

DE (1)