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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: AZD1236; Drug: Placebo

• Registration Number: NCT00758459
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Study Completion: 2009-03
• Status Verified: 2011-07
• Results First Submitted: 2011-07-25
• Results First Submitted QC: 2011-07-25
• Last Update Submitted: 2011-07-25
• Results First Posted: 2011-08-19
• Last Update Posted: 2011-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD1236	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	all study visits	Number of patients who had an Adverse Event

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 Second (FEV1)	Before treatment and after 1, 2, 4 and 6 weeks of treatment	Change in FEV1 from baseline to end of treatment
Forced Vital Capacity (FVC)	Before treatment and after 1, 2, 4 and 6 weeks of treatment	Change in FVC from baseline to end of treatment
Vital Capacity (VC)	Before treatment and after 1, 2, 4 and 6 weeks of treatment	Change in VC from baseline to end of treatment
Inspiratory Capacity (IC)	Before treatment and after 1, 2, 4 and 6 weeks of treatment	Change in IC from baseline to end of treatment
Forced Expiratory Flow (FEF)25-75%	Before treatment and after 1, 2, 4 and 6 weeks of treatment	Change in FEF from baseline to end of treatment
Peak Expiratory Flow (PEF) Morning	Daily during run-in and treatment	Change in PEF from average during run-in to average during the last 4 w of treatment
Peak Expiratory Flow (PEF) Evening	Daily during run-in and treatment	Change in PEF from average during run-in to average during the last 4 w of treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total	Before treatment and after 1, 2, 4 and 6 weeks of treatment	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)
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness	Daily during run-in and treatment	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)
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness	Daily during run-in and treatment	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)
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score	Daily during run-in and treatment	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)
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings	Daily during run-in and treatment	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)
6-minute Walk Test	Before treatment and after 6 weeks of treatment	Change from baseline to end of treatment

Trial Locations

Locations (1)

Research Site; 🇸🇰 Zilina, Slovakia