Phase 2
Completed N=28
The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01205269 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose — 1.67; 1.73; 1.64 L
Summary
The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose |
1.67; 1.73; 1.64 | — |
| PRIMARY Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose |
1.53; 1.60; 1.49 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose |
1.49; 1.54; 1.44 | — |
| SECONDARY Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose |
3.35; 3.39; 3.28 | — |
| SECONDARY Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose |
130.7; 131.2; 132.2 | — |
| SECONDARY Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose |
77.9; 77.5; 77.7 | — |
| SECONDARY Pulse, Average Effect Over 0 - 4 Hours Post-dose |
77.3; 76.0; 74.9 | — |
| SECONDARY Heart Rate, Average Effect Over 0 - 4 Hours Post-dose |
76.2; 75.0; 72.8 | — |
| SECONDARY QTcF, Average Effect Over 0 - 4 Hours Post-dose |
412.8; 409.1; 411.9 | — |
| SECONDARY Plasma AZD8683 Cmax |
0.0578; 0.2791 | — |
| SECONDARY Plasma AZD8683 AUC0-24 |
0.1872; 0.8427 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01205269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.