A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (CIRRUS)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01233232
First received: November 2, 2010
Last updated: April 1, 2011
Last verified: April 2011
  Purpose

The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease


Condition Intervention Phase
Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD)
Laymen Terminology Chronic Bronchitis and Emphysema
Drug: Placebo
Drug: AZD5069 50mg
Drug: AZD5069 80mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 4 Week, Double Blind, Placebo Controlled, Randomised, Parallel Group, Multicentre, Phase IIa Study to Investigate the Safety and Tolerability of AZD5069 as Oral Capsules in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety and tolerability variables (Adverse Events, ECG, physical examination, safety blood samples, vital signs, body temperature, lung function tests) [ Time Frame: Weekly safety measurements during the study from screening period to follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • AZD5069 concentration in plasma and resulting PK parameters [ Time Frame: From first dose until 5 hours after the last dose ] [ Designated as safety issue: No ]
  • Levels of circulating neutrophils in blood [ Time Frame: From first dose until 5 hours after the last dose ] [ Designated as safety issue: Yes ]

Enrollment: 109
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo dose
Drug: Placebo
Oral dose bid
Experimental: 2
Treatment arm AZD5069 50mg
Drug: AZD5069 50mg
Oral dose bid
Experimental: 3
Treatment arm AZD5069 80mg
Drug: AZD5069 80mg
Oral dose bid

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of COPD with symptoms for more than one year before screening
  • Body mass index of 18-30 kg/m2 and weight of 50-100kg
  • Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for one year) at screening
  • FEV1 of 30% or above and less than 80% of the predicted normal value post-bronchodilator at screening
  • FEV1/FVC less than 70% post-bronchodilator at screening

Exclusion Criteria:

  • Any clinically significant disease or disorder
  • Exacerbation of COPD which was not resolved within 30 days of first dosing
  • Patients who have received live or live-attenuated vaccine in the 2 weeks prior to first dosing
  • Asthma and any current respiratory tract disorder other than COPD which is considered to be clinically significant
  • Disease history suggesting reduced or abnormal immune function other than that related to COPD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233232

Locations
Bulgaria
Research Site
Sofia, Bulgaria
Germany
Research Site
Berlin, Germany
Research Site
GROßHANSDORF, Germany
Hungary
Research Site
Debrecen, Hungary
Research Site
Pécs, Hungary
Research Site
Szeged, Hungary
Research Site
Százhalombatta, Hungary
Ukraine
Research Site
Kyiv, Ukraine
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: Joher Raniwalla/Medical Science Director, AstraZeneca R&D, Alderley Park
ClinicalTrials.gov Identifier: NCT01233232     History of Changes
Other Study ID Numbers: D3550C00002, 2010-021217-23
Study First Received: November 2, 2010
Last Updated: April 1, 2011
Health Authority: Bulgaria: Bulgarian Drug Agency
Germany: National Regulatory Authority - BfArM (Bundesinstitut fur Arzneimittel und Medizinpordukte)
Hungary: National Institute of Pharmacy
Ukraine: Ministry of Healthcare of Ukraine The State Pharmacological Centre of Ministry of Health

Keywords provided by AstraZeneca:
Chronic Obstructive Pulmonary Disease, Neutrophil, Respiratory Disease

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014