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Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol

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ClinicalTrials.gov Identifier: NCT01023516
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : August 3, 2012
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: AZD9668
Drug: Placebo
Enrollment 615
Recruitment Details First patient enrolled 24 November 2009. Last patient completed 18 August 2010. Study conducted at 79 centres in 6 countries (Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia).
Pre-assignment Details 3- or 4-week run-in period on budesonide/formoterol twice daily to stabilise patients on maintenance therapy before randomisation. Patients already on budesonide/formoterol required a 3-week run-in period and patients on ICS as monotherapy or in combination with any long-acting bronchodilator required a 4-week run-in period.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks Matched Placebo Tablets
Period Title: Overall Study
Started 313 302
Completed 289 284
Not Completed 24 18
Reason Not Completed
Voluntary discontinuation             7             5
Adverse Event             9             6
Safety reason             0             3
Study-specific criteria             4             2
Incorrect enrolment             4             2
Arm/Group Title 60 mg AZD9668 Placebo Total
Hide Arm/Group Description AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks Matched Placebo Tablets Total of all reporting groups
Overall Number of Baseline Participants 313 302 615
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 313 participants 302 participants 615 participants
62
(42 to 80)
61
(41 to 79)
61.5
(41 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 313 participants 302 participants 615 participants
Female
80
  25.6%
81
  26.8%
161
  26.2%
Male
233
  74.4%
221
  73.2%
454
  73.8%
1.Primary Outcome
Title Baseline Pre-bronchodilator FEV1 (L)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 309 301
Mean (Standard Deviation)
Unit of Measure: L
1.49  (0.539) 1.44  (0.519)
2.Primary Outcome
Title End-value Pre-bronchodilator FEV1 (L)
Hide Description End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 309 301
Least Squares Mean (Standard Error)
Unit of Measure: L
1.45  (0.015) 1.43  (0.015)
3.Secondary Outcome
Title Post-bronchodilator FEV1 (L) - Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 300
Mean (Standard Deviation)
Unit of Measure: L
1.59  (0.530) 1.56  (0.518)
4.Secondary Outcome
Title Post-bronchodilator FEV1 (L) - End-value
Hide Description End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 300
Least Squares Mean (Standard Error)
Unit of Measure: L
1.56  (0.014) 1.54  (0.015)
5.Secondary Outcome
Title Pre-bronchodilator FVC (L) - Baseline
Hide Description Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 309 301
Mean (Standard Deviation)
Unit of Measure: L
2.98  (0.781) 2.94  (0.806)
6.Secondary Outcome
Title Pre-bronchodilator FVC (L) - End-value
Hide Description End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 309 301
Least Squares Mean (Standard Error)
Unit of Measure: L
2.94  (0.022) 2.93  (0.022)
7.Secondary Outcome
Title Post-bronchodilator FVC (L) - Baseline
Hide Description Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 300
Mean (Standard Deviation)
Unit of Measure: L
3.16  (0.787) 3.12  (0.822)
8.Secondary Outcome
Title Post-bronchodilator FVC (L) - End-value
Hide Description End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 300
Least Squares Mean (Standard Error)
Unit of Measure: L
3.11  (0.021) 3.11  (0.021)
9.Secondary Outcome
Title Baseline Pre-bronchodilator FEV6 (L)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 309 301
Mean (Standard Deviation)
Unit of Measure: L
2.68  (0.729) 2.61  (0.714)
10.Secondary Outcome
Title End-value Pre-bronchodilator FEV6 (L)
Hide Description End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 309 301
Least Squares Mean (Standard Error)
Unit of Measure: L
2.61  (0.019) 2.61  (0.019)
11.Secondary Outcome
Title Baseline Post-bronchodilator FEV6 (L)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 300
Mean (Standard Deviation)
Unit of Measure: L
2.85  (0.724) 2.79  (0.716)
12.Secondary Outcome
Title End-value Post-bronchodilator FEV6 (L)
Hide Description End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 300
Least Squares Mean (Standard Error)
Unit of Measure: L
2.77  (0.017) 2.78  (0.018)
13.Secondary Outcome
Title Baseline Pre-bronchodilator FEF25-75% (L/Sec)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 307 301
Mean (Standard Deviation)
Unit of Measure: L/sec
0.60  (0.380) 0.55  (0.324)
14.Secondary Outcome
Title End-value Pre-bronchodilator FEF25-75% (L/Sec)
Hide Description End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 307 301
Least Squares Mean (Standard Error)
Unit of Measure: L/sec
0.57  (0.016) 0.56  (0.016)
15.Secondary Outcome
Title Baseline Post-bronchodilator FEF25-75% (L/Sec)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 299
Mean (Standard Deviation)
Unit of Measure: L/sec
0.64  (0.367) 0.60  (0.333)
16.Secondary Outcome
Title End-value Post-bronchodilator FEF25-75% (L/Sec)
Hide Description End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 299
Least Squares Mean (Standard Error)
Unit of Measure: L/sec
0.62  (0.016) 0.61  (0.016)
17.Secondary Outcome
Title Pre-bronchodilator IC (L) - Baseline
Hide Description Inspiratory capacity (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 301
Mean (Standard Deviation)
Unit of Measure: L
2.21  (0.661) 2.17  (0.661)
18.Secondary Outcome
Title Pre-bronchodilator IC (L) - End-value
Hide Description End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 301
Least Squares Mean (Standard Error)
Unit of Measure: L
2.13  (0.024) 2.14  (0.025)
19.Secondary Outcome
Title Post-bronchodilator IC (L) - Baseline
Hide Description Inspiratory capacity (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 299
Mean (Standard Deviation)
Unit of Measure: L
2.33  (0.718) 2.30  (0.665)
20.Secondary Outcome
Title Post-bronchodilator IC (L) - End-value
Hide Description End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Time Frame up to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 299
Least Squares Mean (Standard Error)
Unit of Measure: L
2.30  (0.023) 2.27  (0.023)
21.Secondary Outcome
Title PEF - Baseline Measured by Patient at Home (L/Min) in the Morning
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 312 301
Mean (Standard Deviation)
Unit of Measure: L/min
215.60  (98.406) 213.24  (96.803)
22.Secondary Outcome
Title PEF - End-value Measured by Patient at Home (L/Min) in the Morning
Hide Description Peak expiratory flow (PEF)
Time Frame Last 6 weeks on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 312 301
Least Squares Mean (Standard Error)
Unit of Measure: L/min
208.68  (2.153) 211.93  (2.189)
23.Secondary Outcome
Title FEV1 - Baseline Measured by Patient at Home (L) in the Morning
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 312 301
Mean (Standard Deviation)
Unit of Measure: L
1.40  (0.546) 1.34  (0.516)
24.Secondary Outcome
Title FEV1 - End-value Measured by Patient at Home (L) in the Morning
Hide Description Forced Expiratory Volume in 1 second (L)
Time Frame Last 6 weeks on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 312 301
Least Squares Mean (Standard Error)
Unit of Measure: L
1.32  (0.012) 1.32  (0.012)
25.Secondary Outcome
Title EXACT - Baseline Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 311 300
Mean (Standard Deviation)
Unit of Measure: units on a scale
45.47  (9.683) 46.01  (8.900)
26.Secondary Outcome
Title EXACT - End-value Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 311 300
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
42.78  (0.473) 43.07  (0.480)
27.Secondary Outcome
Title BCSS - Baseline Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 312 301
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.26  (1.787) 5.44  (1.765)
28.Secondary Outcome
Title BCSS - End-value Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 312 301
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.68  (0.085) 4.68  (0.086)
29.Secondary Outcome
Title Sputum Colour - Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 300 298
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.87  (0.901) 1.88  (0.807)
30.Secondary Outcome
Title Sputum Colour - End Value
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 300 298
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.63  (0.042) 1.70  (0.042)
31.Secondary Outcome
Title Use of Reliever Medication
Hide Description Daily average of number of inhalations of reliever medication
Time Frame Last 6 weeks on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 310 299
Least Squares Mean (Standard Error)
Unit of Measure: inhalations
3.40  (0.124) 3.37  (0.126)
32.Secondary Outcome
Title Incremental Shuttle Walk Test - Baseline
Hide Description Endurance time (s)
Time Frame Day 1
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The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 312 301
Mean (Standard Deviation)
Unit of Measure: seconds
351  (119.5) 352  (108.3)
33.Secondary Outcome
Title Incremental Shuttle Walk Test - End Value
Hide Description [Not Specified]
Time Frame Week 12 - visit 6
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 297 287
Least Squares Mean (Standard Error)
Unit of Measure: seconds
363.6  (3.39) 363.7  (3.44)
34.Secondary Outcome
Title Endurance Shuttle Walk Test - Baseline
Hide Description Endurance time (s)
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 312 301
Mean (Standard Deviation)
Unit of Measure: seconds
419  (269.4) 449  (292.9)
35.Secondary Outcome
Title Endurance Shuttle Walk Test - End Value
Hide Description Assessed at vist 6 -( last on treatment clinic visit)
Time Frame Week 12 - visit 6
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 299 286
Least Squares Mean (Standard Error)
Unit of Measure: seconds
449.6  (10.49) 459.9  (10.68)
36.Secondary Outcome
Title St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 295 280
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
54.52  (16.863) 54.87  (17.575)
37.Secondary Outcome
Title St George's Respiratory Questionnaire (COPD) - End-value Overall Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 295 280
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
49.89  (0.777) 50.66  (0.796)
38.Secondary Outcome
Title Exacerbations - Clinic Defined
Hide Description Number of patients having a clinic defined disease exacerbation.
Time Frame Duration of the the treatment period - 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description:
AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
Matched Placebo Tablets
Overall Number of Participants Analyzed 312 301
Measure Type: Number
Unit of Measure: Participants
22 29
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 60 mg AZD9668 Placebo
Hide Arm/Group Description AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks Matched Placebo Tablets
All-Cause Mortality
60 mg AZD9668 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
60 mg AZD9668 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/313 (2.88%)   14/302 (4.64%) 
Cardiac disorders     
MYOCARDIAL ISCHAEMIA  1  0/313 (0.00%)  2/302 (0.66%) 
ACUTE MYOCARDIAL INFARCTION  1  0/313 (0.00%)  1/302 (0.33%) 
ANGINA PECTORIS  1  0/313 (0.00%)  1/302 (0.33%) 
BUNDLE BRANCH BLOCK RIGHT  1  1/313 (0.32%)  0/302 (0.00%) 
CARDIAC FAILURE  1  0/313 (0.00%)  1/302 (0.33%) 
Infections and infestations     
PNEUMONIA  1  1/313 (0.32%)  3/302 (0.99%) 
POST PROCEDURAL INFECTION  1  0/313 (0.00%)  1/302 (0.33%) 
PYELONEPHRITIS ACUTE  1  1/313 (0.32%)  0/302 (0.00%) 
Injury, poisoning and procedural complications     
RADIUS FRACTURE  1  1/313 (0.32%)  0/302 (0.00%) 
TIBIA FRACTURE  1  0/313 (0.00%)  1/302 (0.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
LARYNGEAL CANCER  1  0/313 (0.00%)  1/302 (0.33%) 
LUNG NEOPLASM MALIGNANT  1  1/313 (0.32%)  0/302 (0.00%) 
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED  1  0/313 (0.00%)  1/302 (0.33%) 
Nervous system disorders     
SYNCOPE  1  0/313 (0.00%)  0/302 (0.00%) 
Renal and urinary disorders     
RENAL COLIC  1  0/313 (0.00%)  1/302 (0.33%) 
Respiratory, thoracic and mediastinal disorders     
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  4/313 (1.28%)  1/302 (0.33%) 
ACUTE PULMONARY OEDEMA  1  0/313 (0.00%)  1/302 (0.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
60 mg AZD9668 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/313 (0.00%)   0/302 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01023516    
Other Study ID Numbers: D0520C00020
First Submitted: December 1, 2009
First Posted: December 2, 2009
Results First Submitted: January 24, 2012
Results First Posted: August 3, 2012
Last Update Posted: August 3, 2012