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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: AZD9668 Placebo
- Registration Number
- NCT00949975
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 838
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 AZD9668 AZD9668 active treatment 3 AZD9668 AZD9668 active treatment 4 AZD9668 Placebo AZD9668 placebo treatment 1 AZD9668 AZD9668 active treatment
- Primary Outcome Measures
Name Time Method Baseline Pre-bronchodilator FEV1 (L) Day 1 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) Measured at clinic visits: 1, 4, 8 and 12 weeks End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
- Secondary Outcome Measures
Name Time Method Post-bronchodilator FEV1 (L) - Baseline Day 1 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 Measured at clinic visits: 1, 4, 8 and 12 weeks End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Pre-bronchodilator FVC (L) - Baseline Day 1 Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
Pre-bronchodilator FVC (L) - End-value Measured at clinic visits: 1, 4, 8 and 12 weeks End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Post-bronchodilator FVC (L) - Baseline Day 1 Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
Post-bronchodilator FVC (L) - End-value Measured at clinic visits: 1, 4, 8 and 12 weeks End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Pre-bronchodilator IC (L) - Baseline Day 1 Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
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 (L/min)
Pre-bronchodilator IC (L) - End-value Measured at clinic visits: 1, 4, 8 and 12 weeks End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
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
Post-bronchodilator IC (L) - Baseline Day 1 Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
Post-bronchodilator IC (L) - End-value Measured at clinic visits: 1, 4, 8 and 12 weeks End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
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 Measured daily in the evening for 12 weeks 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 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 Measured daily in the evening for 12 weeks 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 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 Measured at clinic visits:1, 4, 8 and 12 weeks 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
Six-minute Walk Test - Distance Walked at Baseline (m) Day 1 Six-minute Walk Test - End-value Distance Walked (m) Measured Day 1 and 12 weeks distance walked on 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
🇺🇦Lugansk, Ukraine