Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT01023516
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 615
- Diagnosis of COPD with symptoms over 1 year
- FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator
- Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation
- At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit
- Past history or current evidence of clinically significant heart disease
- Current diagnosis of asthma
- Patients who require long term oxygen therapy
- Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD9668 - 2 Placebo -
- Primary Outcome Measures
Name Time Method Baseline Pre-bronchodilator FEV1 (L) Day 1 Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
End-value Pre-bronchodilator FEV1 (L) up to week 12 End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
- Secondary Outcome Measures
Name Time Method Incremental Shuttle Walk Test - End Value Week 12 - visit 6 Baseline Pre-bronchodilator FEV6 (L) Day 1 Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
End-value Pre-bronchodilator FEV6 (L) up to week 12 End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Post-bronchodilator FEV1 (L) - Baseline Day 1 Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Post-bronchodilator FEV1 (L) - End-value up to week 12 End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Pre-bronchodilator FVC (L) - Baseline Day 1 Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Pre-bronchodilator FVC (L) - End-value up to week 12 End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Endurance Shuttle Walk Test - Baseline Day 1 Endurance time (s)
Post-bronchodilator FVC (L) - Baseline Day 1 Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Post-bronchodilator FVC (L) - End-value up to week 12 End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Baseline Post-bronchodilator FEV6 (L) Day 1 Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.
End-value Post-bronchodilator FEV6 (L) up to week 12 End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Baseline Pre-bronchodilator FEF25-75% (L/Sec) Day 1 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.
End-value Pre-bronchodilator FEF25-75% (L/Sec) up to week 12 End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Baseline Post-bronchodilator FEF25-75% (L/Sec) Day 1 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.
End-value Post-bronchodilator FEF25-75% (L/Sec) up to week 12 End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Pre-bronchodilator IC (L) - Baseline Day 1 Inspiratory capacity (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Pre-bronchodilator IC (L) - End-value up to week 12 End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Post-bronchodilator IC (L) - Baseline Day 1 Inspiratory capacity (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Post-bronchodilator IC (L) - End-value up to week 12 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 Baseline 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 Last 6 weeks on treatment Peak expiratory flow (PEF)
FEV1 - Baseline Measured by Patient at Home (L) in the Morning Baseline 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 Last 6 weeks on treatment Forced Expiratory Volume in 1 second (L)
EXACT - Baseline Total Score Baseline 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 Last 6 weeks on treatment 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).
BCSS - Baseline Total Score Baseline 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 Last 6 weeks on treatment 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).
Sputum Colour - Baseline 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 End of treatment week 12 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 Last 6 weeks on treatment Daily average of number of inhalations of reliever medication
Incremental Shuttle Walk Test - Baseline Day 1 Endurance time (s)
Endurance Shuttle Walk Test - End Value Week 12 - visit 6 Assessed at vist 6 -( last on treatment clinic visit)
St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline Day 1 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 Measured Day 1 and 12 weeks 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 Duration of the the treatment period - 12 weeks Number of patients having a clinic defined disease exacerbation.
Trial Locations
- Locations (1)
Research Site
🇸🇰Zilina, Slovakia