NCT00949975
Completed
Phase 2
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
ConditionsChronic Obstructive Pulmonary Disease
Overview
- Phase
- Phase 2
- Intervention
- AZD9668
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- AstraZeneca
- Enrollment
- 838
- Locations
- 1
- Primary Endpoint
- Baseline Pre-bronchodilator FEV1 (L)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
AZD9668 active treatment
Intervention: AZD9668
2
AZD9668 active treatment
Intervention: AZD9668
3
AZD9668 active treatment
Intervention: AZD9668
4
AZD9668 placebo treatment
Intervention: AZD9668 Placebo
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Post-bronchodilator FEV1 (L) - Baseline(Day 1)
- Post-bronchodilator FEV1 (L) - End-value(Measured at clinic visits: 1, 4, 8 and 12 weeks)
- Pre-bronchodilator FVC (L) - Baseline(Day 1)
- Pre-bronchodilator FVC (L) - End-value(Measured at clinic visits: 1, 4, 8 and 12 weeks)
- Post-bronchodilator FVC (L) - Baseline(Day 1)
- Post-bronchodilator FVC (L) - End-value(Measured at clinic visits: 1, 4, 8 and 12 weeks)
- Pre-bronchodilator IC (L) - Baseline(Day 1)
- Pre-bronchodilator IC (L) - End-value(Measured at clinic visits: 1, 4, 8 and 12 weeks)
- Post-bronchodilator IC (L) - Baseline(Day 1)
- Post-bronchodilator IC (L) - End-value(Measured at clinic visits: 1, 4, 8 and 12 weeks)
- PEF - Baseline Measured by Patient at Home (L/Min) in the Morning(Baseline)
- PEF - End-value Measured by Patient at Home (L/Min) in the Morning(Last 6 weeks on treatment)
- FEV1 - Baseline Measured by Patient at Home (L) in the Morning(Baseline)
- FEV1 - End-value Measured by Patient at Home (L) in the Morning(Last 6 weeks on treatment)
- EXACT - Baseline Total Score(Baseline)
- EXACT - End-value Total Score(Measured daily in the evening for 12 weeks)
- BCSS - Baseline Total Score(Baseline)
- BCSS - End-value Total Score(Measured daily in the evening for 12 weeks)
- Sputum Colour - Baseline(Baseline)
- Sputum Colour - End Value(Measured at clinic visits:1, 4, 8 and 12 weeks)
- Use of Reliever Medication(Last 6 weeks on treatment)
- 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)
- St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline(Day 1)
- St George's Respiratory Questionnaire (COPD) - End-value Overall Score(Measured Day 1 and 12 weeks)
- Exacerbations - Clinic Defined(Duration of the the treatment period - 12 weeks)
Study Sites (1)
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