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 |
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Recruitment Status :
Completed
First Posted : December 2, 2009
Results First Posted : August 3, 2012
Last Update Posted : August 3, 2012
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Drug: AZD9668 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 615 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multinational, Phase IIb Study to Evaluate the Efficacy and Safety of 60mg AZD9668 Administered Orally Twice Daily to Subjects With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Budesonide/Formoterol |
| Study Start Date : | November 2009 |
| Actual Primary Completion Date : | August 2010 |
| Actual Study Completion Date : | August 2010 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: AZD9668
2 x 30 mg oral tablets bd for 12 weeks |
| Placebo Comparator: 2 |
Drug: Placebo
2 x matched placebo to oral tablet bd for 12 weeks |
Primary Outcome Measures :
- Baseline Pre-bronchodilator FEV1 (L) [ Time Frame: 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) [ Time Frame: up to week 12 ]End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Secondary Outcome Measures :
- Post-bronchodilator FEV1 (L) - Baseline [ Time Frame: 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 [ Time Frame: up to week 12 ]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 (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
- Pre-bronchodilator FVC (L) - End-value [ Time Frame: up to week 12 ]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 (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
- Post-bronchodilator FVC (L) - End-value [ Time Frame: up to week 12 ]End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
- Baseline Pre-bronchodilator FEV6 (L) [ Time Frame: 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) [ Time Frame: up to week 12 ]End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
- Baseline Post-bronchodilator FEV6 (L) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: up to week 12 ]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 (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
- Pre-bronchodilator IC (L) - End-value [ Time Frame: up to week 12 ]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 (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
- Post-bronchodilator IC (L) - End-value [ Time Frame: 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 [ 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 (PEF)
- 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: 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 [ 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: 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 [ 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: 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 [ Time Frame: Last 6 weeks on treatment ]Daily average of number of inhalations of reliever medication
- Incremental Shuttle Walk Test - Baseline [ Time Frame: Day 1 ]Endurance time (s)
- Incremental Shuttle Walk Test - End Value [ Time Frame: Week 12 - visit 6 ]
- Endurance Shuttle Walk Test - Baseline [ Time Frame: Day 1 ]Endurance time (s)
- Endurance Shuttle Walk Test - End Value [ Time Frame: Week 12 - visit 6 ]Assessed at 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 |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
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): NCT01023516
Locations
Show 67 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Piotr Kuna, Professor | Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01023516 |
| Other Study ID Numbers: |
D0520C00020 |
| First Posted: | December 2, 2009 Key Record Dates |
| Results First Posted: | August 3, 2012 |
| Last Update Posted: | August 3, 2012 |
| Last Verified: | June 2012 |
Keywords provided by AstraZeneca:
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Chronic obstructive pulmonary lung respiratory disease |
efficacy placebo-controlled COPD FEV1 St Georges Respiratory Questionnaire |
Additional relevant MeSH terms:
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |