The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
615
Baseline Pre-bronchodilator FEV1 (L)
Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time frame: Day 1
End-value Pre-bronchodilator FEV1 (L)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time frame: up to week 12
Post-bronchodilator FEV1 (L) - Baseline
Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Time frame: Day 1
Post-bronchodilator FEV1 (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time frame: up to week 12
Pre-bronchodilator FVC (L) - Baseline
Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time frame: Day 1
Pre-bronchodilator FVC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time frame: up to week 12
Post-bronchodilator FVC (L) - Baseline
Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Time frame: Day 1
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Research Site
Lovech, Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Rousse, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Stara Zagora, Bulgaria
Research Site
Troyan Municipality, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Jihlava, Czechia
Research Site
Jindřichův Hradec, Czechia
...and 56 more locations
Post-bronchodilator FVC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time frame: up to week 12
Baseline Pre-bronchodilator FEV6 (L)
Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time frame: Day 1
End-value Pre-bronchodilator FEV6 (L)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time frame: up to week 12
Baseline Post-bronchodilator FEV6 (L)
Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.
Time frame: Day 1
End-value Post-bronchodilator FEV6 (L)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time frame: up to week 12
Baseline Pre-bronchodilator FEF25-75% (L/Sec)
Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time frame: Day 1
End-value Pre-bronchodilator FEF25-75% (L/Sec)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time frame: up to week 12
Baseline Post-bronchodilator FEF25-75% (L/Sec)
Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Time frame: Day 1
End-value Post-bronchodilator FEF25-75% (L/Sec)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time frame: up to week 12
Pre-bronchodilator IC (L) - Baseline
Inspiratory capacity (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time frame: Day 1
Pre-bronchodilator IC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time frame: up to week 12
Post-bronchodilator IC (L) - Baseline
Inspiratory capacity (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Time frame: Day 1
Post-bronchodilator IC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time frame: up to week 12
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.
Time frame: Baseline
PEF - End-value Measured by Patient at Home (L/Min) in the Morning
Peak expiratory flow (PEF)
Time frame: Last 6 weeks on treatment
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.
Time frame: Baseline
FEV1 - End-value Measured by Patient at Home (L) in the Morning
Forced Expiratory Volume in 1 second (L)
Time frame: Last 6 weeks on treatment
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.
Time frame: Baseline
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).
Time frame: 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.
Time frame: Baseline
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).
Time frame: 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).
Time frame: Baseline
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
Time frame: End of treatment week 12
Use of Reliever Medication
Daily average of number of inhalations of reliever medication
Time frame: Last 6 weeks on treatment
Incremental Shuttle Walk Test - Baseline
Endurance time (s)
Time frame: Day 1
Incremental Shuttle Walk Test - End Value
Time frame: Week 12 - visit 6
Endurance Shuttle Walk Test - Baseline
Endurance time (s)
Time frame: Day 1
Endurance Shuttle Walk Test - End Value
Assessed at vist 6 -( last on treatment clinic visit)
Time frame: Week 12 - visit 6
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)).
Time frame: Day 1
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)
Time frame: Measured Day 1 and 12 weeks
Exacerbations - Clinic Defined
Number of patients having a clinic defined disease exacerbation.
Time frame: Duration of the the treatment period - 12 weeks