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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01153321
First received: June 28, 2010
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Lung Disease
Drug: AZD2423
Drug: AZD2423 Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase IIa Study to Investigate the Effects of 100mg AZD2423 as an Oral Tablet in Subjects With Mild COPD Following Segmental Endobronchial LPS Instillation

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Absolute monocyte count and leucocyte differential in bronchoalveolar lavage fluid (BAL) [ Time Frame: Visits at defined time points over the 11 day treatment for routine safety monitoring ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory cell infiltrate and inflammatory phenotype in endobronchial biopsies [ Time Frame: Bronchial biopsies collected for evaluation at Visit 4 and 5. ] [ Designated as safety issue: No ]
  • Chronic Obstructive Pulmonary Disease (COPD) biomarker concentrations in BAL and blood [ Time Frame: Blood samples for biomarkers collected at visits 2 to 6 and BAL collected at Visits 4 and 5. ] [ Designated as safety issue: No ]
  • AZD2423 concentration in plasma assessed by: Maximum plasma concentration (Cmax), time to Cmax, Area under the plasma concentration-time curve at steady state from zero to 24h (AUCt) [ Time Frame: Multiple PK samples from Visit 3 to Visit 5 ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral treatment
Drug: AZD2423
100mg Oral dose od
Placebo Comparator: 2
Oral treatment
Drug: AZD2423 Placebo
Oral dose od

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153321

Locations
Germany
Research Site
Hannover, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bengt Larsson AstraZeneca R&D
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01153321     History of Changes
Other Study ID Numbers: D3320C00001, 2010-020141-26
Study First Received: June 28, 2010
Last Updated: August 24, 2011
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Respiratory disease
chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014