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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ClinicalTrials.gov Identifier: NCT00949975 |
Recruitment Status :
Completed
First Posted : July 31, 2009
Results First Posted : August 3, 2012
Last Update Posted : August 3, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease | Drug: AZD9668 Drug: AZD9668 Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 838 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
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 Start Date : | July 2009 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
AZD9668 active treatment
|
Drug: AZD9668
2 x 30 mg oral tablets twice daily (bid) for 12 weeks |
Active Comparator: 2
AZD9668 active treatment
|
Drug: AZD9668
2 x 10 mg oral tablets twice daily (bid) for 12 weeks |
Active Comparator: 3
AZD9668 active treatment
|
Drug: AZD9668
2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks |
Placebo Comparator: 4
AZD9668 placebo treatment
|
Drug: AZD9668 Placebo
2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks |
- Baseline Pre-bronchodilator FEV1 (L) [ Time Frame: 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) [ Time Frame: 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 FEV1 (L) - Baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 ]Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
- Pre-bronchodilator IC (L) - End-value [ Time Frame: 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 IC (L) - Baseline [ Time Frame: 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 [ Time Frame: Measured at clinic visits: 1, 4, 8 and 12 weeks ]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 [ Time Frame: 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 [ Time Frame: Last 6 weeks on treatment ]Peak Expiratory Flow (L/min)
- FEV1 - Baseline Measured by Patient at Home (L) in the Morning [ Time Frame: 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 [ Time Frame: Last 6 weeks on treatment ]Forced Expiratory Volume in 1 second (L)
- EXACT - Baseline Total Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Last 6 weeks on treatment ]Daily average of number of inhalations of reliever medication
- Six-minute Walk Test - Distance Walked at Baseline (m) [ Time Frame: Day 1 ]
- Six-minute Walk Test - End-value Distance Walked (m) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Duration of the the treatment period - 12 weeks ]Number of patients having a clinic defined disease exacerbation

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949975

Principal Investigator: | Claus Volgemeier, Dr. | Director der Klinik fur Innere Medizin mit Schwerpunkt Pneumologie-Universitatsklinikum GieBen und Marburg, D-35043 Marburg, Germany |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00949975 |
Other Study ID Numbers: |
D0520C00012 |
First Posted: | July 31, 2009 Key Record Dates |
Results First Posted: | August 3, 2012 |
Last Update Posted: | August 3, 2012 |
Last Verified: | June 2012 |
Chronic Obstructive Pulmonary Lung Respiratory disease |
Efficacy Safety and tolerability Placebo-controlled Pharmacokinetics COPD |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |