Back to resultsA Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD9668
AZD9668
AZD9668
AZD9668 Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic, Obstructive, Pulmonary, Lung, Respiratory disease, Efficacy, Safety and tolerability, Placebo-controlled, Pharmacokinetics, COPD
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of COPD with symptoms over 1 year
- Smokers or ex-smokers
- Males or post-menopausal females between 40 and 80 years old
- Able to use electronic devices
Exclusion Criteria:
- Past history or current evidence of clinically significant heart disease
- Current diagnosis of asthma
- Patients who require long term oxygen therapy
- Treatment with antibiotics within 4 weeks of study visit 1b
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
AZD9668 active treatment
AZD9668 active treatment
AZD9668 active treatment
AZD9668 placebo treatment
Outcomes
Primary Outcome Measures
Baseline Pre-bronchodilator FEV1 (L)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
End-value Pre-bronchodilator FEV1 (L)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Secondary Outcome Measures
Post-bronchodilator FEV1 (L) - Baseline
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
Post-bronchodilator FEV1 (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Pre-bronchodilator FVC (L) - Baseline
Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
Pre-bronchodilator FVC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Post-bronchodilator FVC (L) - Baseline
Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
Post-bronchodilator FVC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Pre-bronchodilator IC (L) - Baseline
Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
Pre-bronchodilator IC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Post-bronchodilator IC (L) - Baseline
Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
Post-bronchodilator IC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
PEF - Baseline Measured by Patient at Home (L/Min) in the Morning
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment
PEF - End-value Measured by Patient at Home (L/Min) in the Morning
Peak Expiratory Flow (L/min)
FEV1 - Baseline Measured by Patient at Home (L) in the Morning
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment
FEV1 - End-value Measured by Patient at Home (L) in the Morning
Forced Expiratory Volume in 1 second (L)
EXACT - Baseline Total Score
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Baseline is the mean of last 10 days of data before start of treatment.
EXACT - End-value Total Score
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Last 6 weeks on treatment.
BCSS - Baseline Total Score
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status)scale).Baseline is the mean of last 10 days of data before start of treatment
BCSS - End-value Total Score
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0(best health status) to 12(worst possible status)scale). Last 6 weeks on treatment
Sputum Colour - Baseline
Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).
Sputum Colour - End Value
Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).End of treatment week 12
Use of Reliever Medication
Daily average of number of inhalations of reliever medication
Six-minute Walk Test - Distance Walked at Baseline (m)
Six-minute Walk Test - End-value Distance Walked (m)
distance walked on vist 6 - last on treatment clinic visit
St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).
St George's Respiratory Questionnaire (COPD) - End-value Overall Score
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).questionaire assessed on vist 6 -( last on treatment clinic visit)
Exacerbations - Clinic Defined
Number of patients having a clinic defined disease exacerbation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00949975
Brief Title
A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Official Title
A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multinational, Phase IIb Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at 3 Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic, Obstructive, Pulmonary, Lung, Respiratory disease, Efficacy, Safety and tolerability, Placebo-controlled, Pharmacokinetics, COPD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
838 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
AZD9668 active treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
AZD9668 active treatment
Arm Title
3
Arm Type
Active Comparator
Arm Description
AZD9668 active treatment
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
AZD9668 placebo treatment
Intervention Type
Drug
Intervention Name(s)
AZD9668
Intervention Description
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
AZD9668
Intervention Description
2 x 10 mg oral tablets twice daily (bid) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
AZD9668
Intervention Description
2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
AZD9668 Placebo
Intervention Description
2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
Primary Outcome Measure Information:
Title
Baseline Pre-bronchodilator FEV1 (L)
Description
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
Time Frame
Day 1
Title
End-value Pre-bronchodilator FEV1 (L)
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
Measured at clinic visits: 1, 4, 8 and 12 weeks
Secondary Outcome Measure Information:
Title
Post-bronchodilator FEV1 (L) - Baseline
Description
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
Time Frame
Day 1
Title
Post-bronchodilator FEV1 (L) - End-value
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
Measured at clinic visits: 1, 4, 8 and 12 weeks
Title
Pre-bronchodilator FVC (L) - Baseline
Description
Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
Time Frame
Day 1
Title
Pre-bronchodilator FVC (L) - End-value
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
Measured at clinic visits: 1, 4, 8 and 12 weeks
Title
Post-bronchodilator FVC (L) - Baseline
Description
Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
Time Frame
Day 1
Title
Post-bronchodilator FVC (L) - End-value
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
Measured at clinic visits: 1, 4, 8 and 12 weeks
Title
Pre-bronchodilator IC (L) - Baseline
Description
Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
Time Frame
Day 1
Title
Pre-bronchodilator IC (L) - End-value
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
Measured at clinic visits: 1, 4, 8 and 12 weeks
Title
Post-bronchodilator IC (L) - Baseline
Description
Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
Time Frame
Day 1
Title
Post-bronchodilator IC (L) - End-value
Description
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame
Measured at clinic visits: 1, 4, 8 and 12 weeks
Title
PEF - Baseline Measured by Patient at Home (L/Min) in the Morning
Description
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment
Time Frame
Baseline
Title
PEF - End-value Measured by Patient at Home (L/Min) in the Morning
Description
Peak Expiratory Flow (L/min)
Time Frame
Last 6 weeks on treatment
Title
FEV1 - Baseline Measured by Patient at Home (L) in the Morning
Description
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment
Time Frame
Baseline
Title
FEV1 - End-value Measured by Patient at Home (L) in the Morning
Description
Forced Expiratory Volume in 1 second (L)
Time Frame
Last 6 weeks on treatment
Title
EXACT - Baseline Total Score
Description
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Baseline is the mean of last 10 days of data before start of treatment.
Time Frame
Baseline
Title
EXACT - End-value Total Score
Description
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Last 6 weeks on treatment.
Time Frame
Measured daily in the evening for 12 weeks
Title
BCSS - Baseline Total Score
Description
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status)scale).Baseline is the mean of last 10 days of data before start of treatment
Time Frame
Baseline
Title
BCSS - End-value Total Score
Description
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0(best health status) to 12(worst possible status)scale). Last 6 weeks on treatment
Time Frame
Measured daily in the evening for 12 weeks
Title
Sputum Colour - Baseline
Description
Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).
Time Frame
Baseline
Title
Sputum Colour - End Value
Description
Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).End of treatment week 12
Time Frame
Measured at clinic visits:1, 4, 8 and 12 weeks
Title
Use of Reliever Medication
Description
Daily average of number of inhalations of reliever medication
Time Frame
Last 6 weeks on treatment
Title
Six-minute Walk Test - Distance Walked at Baseline (m)
Time Frame
Day 1
Title
Six-minute Walk Test - End-value Distance Walked (m)
Description
distance walked on vist 6 - last on treatment clinic visit
Time Frame
Measured Day 1 and 12 weeks
Title
St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline
Description
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).
Time Frame
Day 1
Title
St George's Respiratory Questionnaire (COPD) - End-value Overall Score
Description
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).questionaire assessed on vist 6 -( last on treatment clinic visit)
Time Frame
Measured Day 1 and 12 weeks
Title
Exacerbations - Clinic Defined
Description
Number of patients having a clinic defined disease exacerbation
Time Frame
Duration of the the treatment period - 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD with symptoms over 1 year
Smokers or ex-smokers
Males or post-menopausal females between 40 and 80 years old
Able to use electronic devices
Exclusion Criteria:
Past history or current evidence of clinically significant heart disease
Current diagnosis of asthma
Patients who require long term oxygen therapy
Treatment with antibiotics within 4 weeks of study visit 1b
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Volgemeier, Dr.
Organizational Affiliation
Director der Klinik fur Innere Medizin mit Schwerpunkt Pneumologie-Universitatsklinikum GieBen und Marburg, D-35043 Marburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Fullerton
State/Province
California
Country
United States
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City
Valparaiso
State/Province
Indiana
Country
United States
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City
Council Bluffs
State/Province
Iowa
Country
United States
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City
Hickory
State/Province
North Carolina
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United States
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City
Jefferson Hills
State/Province
Pennsylvania
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United States
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Gaffney
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South Carolina
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United States
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Greenville
State/Province
South Carolina
Country
United States
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Spartanburg
State/Province
South Carolina
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United States
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City
Boerne
State/Province
Texas
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United States
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City
Concord
State/Province
New South Wales
Country
Australia
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City
Glebe
State/Province
New South Wales
Country
Australia
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City
Kogarah
State/Province
New South Wales
Country
Australia
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City
Carina Heights
State/Province
Queensland
Country
Australia
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City
Adelaide
State/Province
South Australia
Country
Australia
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City
Daw Park
State/Province
South Australia
Country
Australia
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City
Parkville
State/Province
Victoria
Country
Australia
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City
Nedlands
State/Province
Western Australia
Country
Australia
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City
Edmonton
State/Province
Alberta
Country
Canada
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City
Vancouver
State/Province
British Columbia
Country
Canada
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City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
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City
Antigonish
State/Province
Nova Scotia
Country
Canada
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City
Grimsby
State/Province
Ontario
Country
Canada
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Hamilton
State/Province
Ontario
Country
Canada
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Kingston
State/Province
Ontario
Country
Canada
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City
Mississauga
State/Province
Ontario
Country
Canada
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Toronto
State/Province
Ontario
Country
Canada
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City
La Malbaie
State/Province
Quebec
Country
Canada
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City
Mirabel
State/Province
Quebec
Country
Canada
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City
Saint-leonard
State/Province
Quebec
Country
Canada
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Research Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
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City
Berlin
Country
Germany
Facility Name
Research Site
City
Fulda
Country
Germany
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City
Hannover
Country
Germany
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Research Site
City
Leipzig
Country
Germany
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Research Site
City
Marburg
Country
Germany
Facility Name
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City
Seto
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Noda
State/Province
Chiba
Country
Japan
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Research Site
City
Touon
State/Province
Ehime
Country
Japan
Facility Name
Research Site
City
Yukuhashi
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Nihonmatsu
State/Province
Fukushima
Country
Japan
Facility Name
Research Site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Himeji
State/Province
Hyogo
Country
Japan
Facility Name
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City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
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City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Ukyo-ku, Kyoto
State/Province
Kyoto
Country
Japan
Facility Name
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City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
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City
Saeki
State/Province
Oita
Country
Japan
Facility Name
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City
Kishiwada
State/Province
Osaka
Country
Japan
Facility Name
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City
Kita-ku, Sakai
State/Province
Osaka
Country
Japan
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City
Matsue
State/Province
Shimane
Country
Japan
Facility Name
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City
Chuo
State/Province
Tokyo
Country
Japan
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City
Nakano-ku
State/Province
Tokyo
Country
Japan
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City
Tanabe
State/Province
Wakayama
Country
Japan
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City
Bunkyo
Country
Japan
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City
Fukuoka
Country
Japan
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Hiroshima
Country
Japan
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Kagoshima
Country
Japan
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Kochi
Country
Japan
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City
Uijeongbu
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
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City
Wonju
State/Province
Kangwon-do
Country
Korea, Republic of
Facility Name
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City
Anyang
Country
Korea, Republic of
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City
Bucheon
Country
Korea, Republic of
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Daegu
Country
Korea, Republic of
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Seoul
Country
Korea, Republic of
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Iloilo City
Country
Philippines
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City
Lipa City, Batangas
Country
Philippines
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City
Quezon City
Country
Philippines
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Bydgoszcz
Country
Poland
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Checiny
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Poland
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Krakow
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Poland
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Ostrow Wielkopolski
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Poland
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Poznan
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Poland
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Proszowice
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Poland
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Tczew
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Poland
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Wroclaw
Country
Poland
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Zawadzkie
Country
Poland
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Barnaul
State/Province
Russia
Country
Russian Federation
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Ekaterinburg
State/Province
Russia
Country
Russian Federation
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City
Kazan
State/Province
Russia
Country
Russian Federation
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City
Moscow
State/Province
Russia
Country
Russian Federation
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City
Novosibirsk
State/Province
Russia
Country
Russian Federation
Facility Name
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City
St.petersburg
State/Province
Russia
Country
Russian Federation
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City
Bardejov
Country
Slovakia
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City
Bojnice
Country
Slovakia
Facility Name
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Bratislava
Country
Slovakia
Facility Name
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City
Kosice
Country
Slovakia
Facility Name
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City
Nove Mesto Nad Vahom
Country
Slovakia
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Nove Zamky
Country
Slovakia
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City
Poprad
Country
Slovakia
Facility Name
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Presov
Country
Slovakia
Facility Name
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City
Trnava
Country
Slovakia
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City
Zilina
Country
Slovakia
Facility Name
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City
Zvolen
Country
Slovakia
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City
Kaohsiung
Country
Taiwan
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City
Keelung
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Taiwan
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City
Taichung
Country
Taiwan
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City
Taipei
Country
Taiwan
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City
Tao-yuan
Country
Taiwan
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City
Dnipropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Ivano-frankivsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Lugansk
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
25287629
Citation
Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, Dansie EJ, Sethi S. Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. 2014 Oct 7;15(1):124. doi: 10.1186/s12931-014-0124-z.
Results Reference
derived
PubMed Identifier
24432712
Citation
Leidy NK, Murray LT, Jones P, Sethi S. Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Mar;11(3):316-25. doi: 10.1513/AnnalsATS.201309-305OC.
Results Reference
derived
PubMed Identifier
22458939
Citation
Vogelmeier C, Aquino TO, O'Brien CD, Perrett J, Gunawardena KA. A randomised, placebo-controlled, dose-finding study of AZD9668, an oral inhibitor of neutrophil elastase, in patients with chronic obstructive pulmonary disease treated with tiotropium. COPD. 2012 Apr;9(2):111-20. doi: 10.3109/15412555.2011.641803.
Results Reference
derived
Learn more about this trial
A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
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