Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— CERA  

Official title:

A 6 Week Double-Blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of AZD1236as an Oral Tablet in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758459
• Other study ID #: D4260C00003
• Status: Completed
• Phase: Phase 2
• First received: September 23, 2008
• Last updated: July 25, 2011
• Start date: September 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacySlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of COPD for 1 month

• Men or postmenopausal women

• Spirometry values indicating reduced lung function

• Smoking history equivalent to using 20 cigarettes a day for 10 years

Exclusion Criteria:

• Any current respiratory tract disorders other than COPD

• Requirement for regular oxygen therapy

• Use of oral or parenteral glucocorticosteroids within 30 days prior to the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD1236
oral tablet, 75 mg, twice daily during 6 weeks
• Placebo
Dosing to match AZD1236

Locations

Country	Name	City	State
Bulgaria	Research Site	Russe
Bulgaria	Research Site	Sofia
Finland	Research Site	Helsinki
Finland	Research Site	Oulu
Finland	Research Site	Preitila
Germany	Research Site	Berlin
Germany	Research Site	Grobhansdorf
Hungary	Research Site	Gyor
Hungary	Research Site	Komlo
Hungary	Research Site	Pecs
Hungary	Research Site	Vasarosnameny
Slovakia	Research Site	Bojnice
Slovakia	Research Site	Liptovsky Hradok
Slovakia	Research Site	Zilina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Finland,  Germany,  Hungary,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	Number of patients who had an Adverse Event	all study visits	Yes
Secondary	Forced Expiratory Volume in 1 Second (FEV1)	Change in FEV1 from baseline to end of treatment	Before treatment and after 1, 2, 4 and 6 weeks of treatment	No
Secondary	Forced Vital Capacity (FVC)	Change in FVC from baseline to end of treatment	Before treatment and after 1, 2, 4 and 6 weeks of treatment	No
Secondary	Vital Capacity (VC)	Change in VC from baseline to end of treatment	Before treatment and after 1, 2, 4 and 6 weeks of treatment	No
Secondary	Inspiratory Capacity (IC)	Change in IC from baseline to end of treatment	Before treatment and after 1, 2, 4 and 6 weeks of treatment	No
Secondary	Forced Expiratory Flow (FEF)25-75%	Change in FEF from baseline to end of treatment	Before treatment and after 1, 2, 4 and 6 weeks of treatment	No
Secondary	Peak Expiratory Flow (PEF) Morning	Change in PEF from average during run-in to average during the last 4 w of treatment	Daily during run-in and treatment	No
Secondary	Peak Expiratory Flow (PEF) Evening	Change in PEF from average during run-in to average during the last 4 w of treatment	Daily during run-in and treatment	No
Secondary	Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total	Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)	Before treatment and after 1, 2, 4 and 6 weeks of treatment	No
Secondary	Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness	Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)	Daily during run-in and treatment	No
Secondary	Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness	Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)	Daily during run-in and treatment	No
Secondary	Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score	Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)	Daily during run-in and treatment	No
Secondary	Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings	Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)	Daily during run-in and treatment	No
Secondary	6-minute Walk Test	Change from baseline to end of treatment	Before treatment and after 6 weeks of treatment	No