Back to resultsTolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (TOP)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD4818
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, tolerability, inhalation
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of COPD, with symptoms for more than 1 year
- Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
- Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator
Exclusion Criteria:
- Clinical suspicion of active tuberculosis
- Any current clinically significant respiratory tract disorder other than COPD
- History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
AZD4818
Placebo
Outcomes
Primary Outcome Measures
Number of Patients Experiencing Adverse Events
Number of patients who had an Adverse Event
Secondary Outcome Measures
Forced Expiratory Volume 1 (FEV1)
Change in (FEV1) from baseline to end of treatment
Forced Vital Capacity (FVC)
Change in FVC from baseline to end of treatment
Vital Capacity (VC)
Change in VC from baseline to end of treatment
Inspiratory Capacity (IC)
Change from IC baseline to end of treatment
Forced Expiratory Flow (FEF) 25%-75%
Change in FEF from baseline to end of treatment
Peak Expiratory Flow (PEF) Morning
Change from average during run-in to average during treatment
Peak Expiratory Flow (PEF) Evening
Change in PEF from average during run-in to average during treatment
The Clinical COPD ( Chronic Obstructive Pulmonary Disease) 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)
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score
Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
6-minute Walk Test
Change from baseline to end of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00629239
Brief Title
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Acronym
TOP
Official Title
A 4-week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, tolerability, inhalation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD4818
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AZD4818
Intervention Description
Dry Powder, inhalation, b.i.d., 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Patients Experiencing Adverse Events
Description
Number of patients who had an Adverse Event
Time Frame
At all study visits
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume 1 (FEV1)
Description
Change in (FEV1) from baseline to end of treatment
Time Frame
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Title
Forced Vital Capacity (FVC)
Description
Change in FVC from baseline to end of treatment
Time Frame
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Title
Vital Capacity (VC)
Description
Change in VC from baseline to end of treatment
Time Frame
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Title
Inspiratory Capacity (IC)
Description
Change from IC baseline to end of treatment
Time Frame
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Title
Forced Expiratory Flow (FEF) 25%-75%
Description
Change in FEF from baseline to end of treatment
Time Frame
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Title
Peak Expiratory Flow (PEF) Morning
Description
Change from average during run-in to average during treatment
Time Frame
Daily during run-in and treatment
Title
Peak Expiratory Flow (PEF) Evening
Description
Change in PEF from average during run-in to average during treatment
Time Frame
Daily during run-in and treatment
Title
The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total
Description
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)
Time Frame
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Title
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Description
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Time Frame
Daily during run-in and treatment
Title
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Description
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Time Frame
Daily during run-in and treatment
Title
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Description
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Time Frame
Daily during run-in and treatment
Title
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score
Description
Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Time Frame
Daily during run-in and treatment
Title
6-minute Walk Test
Description
Change from baseline to end of treatment
Time Frame
Before treatment and after 4 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of COPD, with symptoms for more than 1 year
Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator
Exclusion Criteria:
Clinical suspicion of active tuberculosis
Any current clinically significant respiratory tract disorder other than COPD
History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huib AM Kerstjens, MD, PhD
Organizational Affiliation
University Medical Centre, Groningen, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Hvidovre
Country
Denmark
Facility Name
Research Site
City
København Nv
Country
Denmark
Facility Name
Research Site
City
Odense C
Country
Denmark
Facility Name
Research Site
City
Helsinki
Country
Finland
Facility Name
Research Site
City
Preitilä
Country
Finland
Facility Name
Research Site
City
Tampere
Country
Finland
Facility Name
Research Site
City
Breda
Country
Netherlands
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Elverum
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
Facility Name
Research Site
City
Lund
Country
Sweden
12. IPD Sharing Statement
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Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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