The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Phase 2
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: AZD8683, 50 mcgDrug: PlaceboDrug: AZD8683, 200 mcg
- Registration Number
- NCT01205269
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.
- Detailed Description
A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Clinical diagnosis of COPD
- Current or ex-smokers
- FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70%
Exclusion Criteria
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings at screening examinations
- Family history or presence of glaucoma
- Need of long term oxygen therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description First 200 mcg, then 50 mcg, then placebo AZD8683, 200 mcg period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo First 50 mcg, then 200 mcg, then placebo AZD8683, 50 mcg period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo First 50 mcg, then 200 mcg, then placebo Placebo period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo First 50 mcg, then 200 mcg, then placebo AZD8683, 200 mcg period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo First 50 mcg, then placebo, then 200 mcg AZD8683, 50 mcg period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg First 50 mcg, then placebo, then 200 mcg Placebo period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg First 50 mcg, then placebo, then 200 mcg AZD8683, 200 mcg period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg First 200 mcg, then placebo, then 50 mcg AZD8683, 50 mcg period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg First 200 mcg, then placebo, then 50 mcg Placebo period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg First 200 mcg, then placebo, then 50 mcg AZD8683, 200 mcg period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg First 200 mcg, then 50 mcg, then placebo AZD8683, 50 mcg period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo First 200 mcg, then 50 mcg, then placebo Placebo period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo First placebo, then 200 mcg, then 50 mcg AZD8683, 50 mcg period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg First placebo, then 200 mcg, then 50 mcg Placebo period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg First placebo, then 200 mcg, then 50 mcg AZD8683, 200 mcg period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg First placebo, then 50 mcg, then 200 mcg AZD8683, 50 mcg period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg First placebo, then 50 mcg, then 200 mcg Placebo period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg First placebo, then 50 mcg, then 200 mcg AZD8683, 200 mcg period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
- Primary Outcome Measures
Name Time Method Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h Maximum FEV1 value
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose 22 h, 24 h, 26 h Trough FEV1 value
- Secondary Outcome Measures
Name Time Method Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h Average FEV1 value
Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h Maximum FVC value
Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose 0, 30 min, 2 h, 4 h Average systolic blood pressure value
Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose 0, 30 min, 2 h, 4 h Average diastolic blood pressure value
Pulse, Average Effect Over 0 - 4 Hours Post-dose 0, 30 min, 2 h, 4 h Average pulse value
Heart Rate, Average Effect Over 0 - 4 Hours Post-dose 0, 30 min, 2 h, 4 h Average heart rate value
QTcF, Average Effect Over 0 - 4 Hours Post-dose 0, 30 min, 2 h, 4 h Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula
Plasma AZD8683 Cmax 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h Maximum plasma concentration of AZD8683
Plasma AZD8683 AUC0-24 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h Area under the AZD8683 plasma concentration curve from 0 to 24 hours
Trial Locations
- Locations (1)
Research Site
🇵🇱Łódź, Poland