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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00949975
Registration number
NCT00949975
Ethics application status
Date submitted
21/07/2009
Date registered
31/07/2009
Date last updated
3/08/2012
Titles & IDs
Public 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
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Scientific 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
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Secondary ID [1]
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0
D0520C00012
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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0
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Condition category
Condition code
Respiratory
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0
0
0
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD9668
Treatment: Drugs - AZD9668
Treatment: Drugs - AZD9668
Treatment: Drugs - AZD9668 Placebo
Active comparator: 1 - AZD9668 active treatment
Active comparator: 2 - AZD9668 active treatment
Active comparator: 3 - AZD9668 active treatment
Placebo comparator: 4 - AZD9668 placebo treatment
Treatment: Drugs: AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
Treatment: Drugs: AZD9668
2 x 10 mg oral tablets twice daily (bid) for 12 weeks
Treatment: Drugs: AZD9668
2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks
Treatment: Drugs: AZD9668 Placebo
2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Baseline Pre-bronchodilator FEV1 (L)
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Assessment method [1]
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Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
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Timepoint [1]
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0
Day 1
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Primary outcome [2]
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0
End-value Pre-bronchodilator FEV1 (L)
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Assessment method [2]
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0
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
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Timepoint [2]
0
0
Measured at clinic visits: 1, 4, 8 and 12 weeks
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Secondary outcome [1]
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0
Post-bronchodilator FEV1 (L) - Baseline
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Assessment method [1]
0
0
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
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Timepoint [1]
0
0
Day 1
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Secondary outcome [2]
0
0
Post-bronchodilator FEV1 (L) - End-value
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Assessment method [2]
0
0
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
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Timepoint [2]
0
0
Measured at clinic visits: 1, 4, 8 and 12 weeks
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Secondary outcome [3]
0
0
Pre-bronchodilator FVC (L) - Baseline
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Assessment method [3]
0
0
Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
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Timepoint [3]
0
0
Day 1
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Secondary outcome [4]
0
0
Pre-bronchodilator FVC (L) - End-value
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Assessment method [4]
0
0
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
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Timepoint [4]
0
0
Measured at clinic visits: 1, 4, 8 and 12 weeks
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Secondary outcome [5]
0
0
Post-bronchodilator FVC (L) - Baseline
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Assessment method [5]
0
0
Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
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Timepoint [5]
0
0
Day 1
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Secondary outcome [6]
0
0
Post-bronchodilator FVC (L) - End-value
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Assessment method [6]
0
0
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
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Timepoint [6]
0
0
Measured at clinic visits: 1, 4, 8 and 12 weeks
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Secondary outcome [7]
0
0
Pre-bronchodilator IC (L) - Baseline
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Assessment method [7]
0
0
Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
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Timepoint [7]
0
0
Day 1
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Secondary outcome [8]
0
0
Pre-bronchodilator IC (L) - End-value
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Assessment method [8]
0
0
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
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Timepoint [8]
0
0
Measured at clinic visits: 1, 4, 8 and 12 weeks
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Secondary outcome [9]
0
0
Post-bronchodilator IC (L) - Baseline
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Assessment method [9]
0
0
Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
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Timepoint [9]
0
0
Day 1
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Secondary outcome [10]
0
0
Post-bronchodilator IC (L) - End-value
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Assessment method [10]
0
0
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
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Timepoint [10]
0
0
Measured at clinic visits: 1, 4, 8 and 12 weeks
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Secondary outcome [11]
0
0
PEF - Baseline Measured by Patient at Home (L/Min) in the Morning
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Assessment method [11]
0
0
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
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Timepoint [11]
0
0
Baseline
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Secondary outcome [12]
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0
PEF - End-value Measured by Patient at Home (L/Min) in the Morning
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Assessment method [12]
0
0
Peak Expiratory Flow (L/min)
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Timepoint [12]
0
0
Last 6 weeks on treatment
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Secondary outcome [13]
0
0
FEV1 - Baseline Measured by Patient at Home (L) in the Morning
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Assessment method [13]
0
0
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
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Timepoint [13]
0
0
Baseline
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Secondary outcome [14]
0
0
FEV1 - End-value Measured by Patient at Home (L) in the Morning
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Assessment method [14]
0
0
Forced Expiratory Volume in 1 second (L)
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Timepoint [14]
0
0
Last 6 weeks on treatment
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Secondary outcome [15]
0
0
EXACT - Baseline Total Score
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Assessment method [15]
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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.
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Timepoint [15]
0
0
Baseline
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Secondary outcome [16]
0
0
EXACT - End-value Total Score
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Assessment method [16]
0
0
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.
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Timepoint [16]
0
0
Measured daily in the evening for 12 weeks
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Secondary outcome [17]
0
0
BCSS - Baseline Total Score
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Assessment method [17]
0
0
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
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Timepoint [17]
0
0
Baseline
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Secondary outcome [18]
0
0
BCSS - End-value Total Score
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Assessment method [18]
0
0
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
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Timepoint [18]
0
0
Measured daily in the evening for 12 weeks
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Secondary outcome [19]
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0
Sputum Colour - Baseline
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Assessment method [19]
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0
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).
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Timepoint [19]
0
0
Baseline
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Secondary outcome [20]
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0
Sputum Colour - End Value
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Assessment method [20]
0
0
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
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Timepoint [20]
0
0
Measured at clinic visits:1, 4, 8 and 12 weeks
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Secondary outcome [21]
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0
Use of Reliever Medication
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Assessment method [21]
0
0
Daily average of number of inhalations of reliever medication
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Timepoint [21]
0
0
Last 6 weeks on treatment
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Secondary outcome [22]
0
0
Six-minute Walk Test - Distance Walked at Baseline (m)
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Assessment method [22]
0
0
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Timepoint [22]
0
0
Day 1
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Secondary outcome [23]
0
0
Six-minute Walk Test - End-value Distance Walked (m)
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Assessment method [23]
0
0
distance walked on vist 6 - last on treatment clinic visit
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Timepoint [23]
0
0
Measured Day 1 and 12 weeks
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Secondary outcome [24]
0
0
St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline
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Assessment method [24]
0
0
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)).
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Timepoint [24]
0
0
Day 1
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Secondary outcome [25]
0
0
St George's Respiratory Questionnaire (COPD) - End-value Overall Score
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Assessment method [25]
0
0
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)
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Timepoint [25]
0
0
Measured Day 1 and 12 weeks
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Secondary outcome [26]
0
0
Exacerbations - Clinic Defined
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Assessment method [26]
0
0
Number of patients having a clinic defined disease exacerbation
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Timepoint [26]
0
0
Duration of the the treatment period - 12 weeks
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Eligibility
Key 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
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Minimum age
40
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2010
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Sample size
Target
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Accrual to date
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Final
838
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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0
Research Site - Concord
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Recruitment hospital [2]
0
0
Research Site - Glebe
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Recruitment hospital [3]
0
0
Research Site - Kogarah
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Recruitment hospital [4]
0
0
Research Site - Carina Heights
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Recruitment hospital [5]
0
0
Research Site - Adelaide
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Recruitment hospital [6]
0
0
Research Site - Daw Park
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Recruitment hospital [7]
0
0
Research Site - Parkville
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Recruitment hospital [8]
0
0
Research Site - Nedlands
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Recruitment postcode(s) [1]
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0
- Concord
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Recruitment postcode(s) [2]
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0
- Glebe
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Recruitment postcode(s) [3]
0
0
- Kogarah
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Recruitment postcode(s) [4]
0
0
- Carina Heights
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Recruitment postcode(s) [5]
0
0
- Adelaide
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Recruitment postcode(s) [6]
0
0
- Daw Park
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Recruitment postcode(s) [7]
0
0
- Parkville
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Recruitment postcode(s) [8]
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0
- Nedlands
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Indiana
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Iowa
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Country [4]
0
0
United States of America
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State/province [4]
0
0
North Carolina
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Pennsylvania
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Country [6]
0
0
United States of America
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State/province [6]
0
0
South Carolina
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Texas
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Country [8]
0
0
Canada
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State/province [8]
0
0
Alberta
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Country [9]
0
0
Canada
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State/province [9]
0
0
British Columbia
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Country [10]
0
0
Canada
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State/province [10]
0
0
Newfoundland and Labrador
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Country [11]
0
0
Canada
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State/province [11]
0
0
Nova Scotia
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Country [12]
0
0
Canada
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State/province [12]
0
0
Ontario
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Country [13]
0
0
Canada
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State/province [13]
0
0
Quebec
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Country [14]
0
0
Canada
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State/province [14]
0
0
Saskatchewan
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Country [15]
0
0
Germany
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State/province [15]
0
0
Berlin
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Country [16]
0
0
Germany
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State/province [16]
0
0
Fulda
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Country [17]
0
0
Germany
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State/province [17]
0
0
Hannover
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Country [18]
0
0
Germany
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State/province [18]
0
0
Leipzig
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Country [19]
0
0
Germany
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State/province [19]
0
0
Marburg
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Country [20]
0
0
Japan
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State/province [20]
0
0
Aichi
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Country [21]
0
0
Japan
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State/province [21]
0
0
Chiba
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Country [22]
0
0
Japan
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State/province [22]
0
0
Ehime
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Country [23]
0
0
Japan
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State/province [23]
0
0
Fukuoka
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Country [24]
0
0
Japan
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State/province [24]
0
0
Fukushima
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Country [25]
0
0
Japan
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State/province [25]
0
0
Hokkaido
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Country [26]
0
0
Japan
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State/province [26]
0
0
Hyogo
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Country [27]
0
0
Japan
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State/province [27]
0
0
Kanagawa
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Country [28]
0
0
Japan
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State/province [28]
0
0
Kyoto
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Country [29]
0
0
Japan
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State/province [29]
0
0
Nagano
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Country [30]
0
0
Japan
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State/province [30]
0
0
Oita
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Country [31]
0
0
Japan
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State/province [31]
0
0
Osaka
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Country [32]
0
0
Japan
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State/province [32]
0
0
Shimane
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Country [33]
0
0
Japan
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State/province [33]
0
0
Tokyo
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Country [34]
0
0
Japan
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State/province [34]
0
0
Wakayama
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Country [35]
0
0
Japan
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State/province [35]
0
0
Bunkyo
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Country [36]
0
0
Japan
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State/province [36]
0
0
Hiroshima
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Country [37]
0
0
Japan
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State/province [37]
0
0
Kagoshima
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Country [38]
0
0
Japan
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State/province [38]
0
0
Kochi
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Country [39]
0
0
Korea, Republic of
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State/province [39]
0
0
Gyeonggi-do
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Country [40]
0
0
Korea, Republic of
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State/province [40]
0
0
Kangwon-do
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Country [41]
0
0
Korea, Republic of
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State/province [41]
0
0
Anyang
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Country [42]
0
0
Korea, Republic of
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State/province [42]
0
0
Bucheon
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Country [43]
0
0
Korea, Republic of
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State/province [43]
0
0
Daegu
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Country [44]
0
0
Korea, Republic of
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State/province [44]
0
0
Seoul
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Country [45]
0
0
Philippines
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State/province [45]
0
0
Iloilo City
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Country [46]
0
0
Philippines
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State/province [46]
0
0
Lipa City, Batangas
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Country [47]
0
0
Philippines
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State/province [47]
0
0
Quezon City
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Bydgoszcz
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Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Checiny
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Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Krakow
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Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Ostrow Wielkopolski
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Country [52]
0
0
Poland
Query!
State/province [52]
0
0
Poznan
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Country [53]
0
0
Poland
Query!
State/province [53]
0
0
Proszowice
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Country [54]
0
0
Poland
Query!
State/province [54]
0
0
Tczew
Query!
Country [55]
0
0
Poland
Query!
State/province [55]
0
0
Wroclaw
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Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Zawadzkie
Query!
Country [57]
0
0
Russian Federation
Query!
State/province [57]
0
0
Russia
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Country [58]
0
0
Slovakia
Query!
State/province [58]
0
0
Bardejov
Query!
Country [59]
0
0
Slovakia
Query!
State/province [59]
0
0
Bojnice
Query!
Country [60]
0
0
Slovakia
Query!
State/province [60]
0
0
Bratislava
Query!
Country [61]
0
0
Slovakia
Query!
State/province [61]
0
0
Kosice
Query!
Country [62]
0
0
Slovakia
Query!
State/province [62]
0
0
Nove Mesto Nad Vahom
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Country [63]
0
0
Slovakia
Query!
State/province [63]
0
0
Nove Zamky
Query!
Country [64]
0
0
Slovakia
Query!
State/province [64]
0
0
Poprad
Query!
Country [65]
0
0
Slovakia
Query!
State/province [65]
0
0
Presov
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Country [66]
0
0
Slovakia
Query!
State/province [66]
0
0
Trnava
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Country [67]
0
0
Slovakia
Query!
State/province [67]
0
0
Zilina
Query!
Country [68]
0
0
Slovakia
Query!
State/province [68]
0
0
Zvolen
Query!
Country [69]
0
0
Taiwan
Query!
State/province [69]
0
0
Kaohsiung
Query!
Country [70]
0
0
Taiwan
Query!
State/province [70]
0
0
Keelung
Query!
Country [71]
0
0
Taiwan
Query!
State/province [71]
0
0
Taichung
Query!
Country [72]
0
0
Taiwan
Query!
State/province [72]
0
0
Taipei
Query!
Country [73]
0
0
Taiwan
Query!
State/province [73]
0
0
Tao-yuan
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Country [74]
0
0
Ukraine
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State/province [74]
0
0
Dnipropetrovsk
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Country [75]
0
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Ukraine
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State/province [75]
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Ivano-frankivsk
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Country [76]
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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State/province [78]
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Lugansk
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00949975
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Trial related presentations / publications
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. 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. 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.
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Public notes
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Contacts
Principal investigator
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Claus Volgemeier, Dr.
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Address
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Director der Klinik fur Innere Medizin mit Schwerpunkt Pneumologie-Universitatsklinikum GieBen und Marburg, D-35043 Marburg, Germany
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00949975
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