Phase 2
N=87
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD) · Laymen Terminology Chronic Bronchitis and Emphysema
Bottom Line
View on ClinicalTrials.gov: NCT01233232 ↗Enrolled (actual)
87
Serious AEs
2.3%
Results posted
May 2015
Primary outcome: Primary: Patients Who Experienced at Least One Adverse Events(s) — 9; 10; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); AZD5069 50mg (Drug); AZD5069 80mg (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients Who Experienced at Least One Adverse Events(s) |
9; 10; 6 | — |
| PRIMARY Number of Participants With Abnormal Physical Examination Findings |
0; 0; 1 | — |
| PRIMARY Number of Participants With Abnormal Electrocardiogram (ECG) |
0; 0; 0 | — |
| PRIMARY Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample) |
-0.12; -1.55; -1.08 | — |
| PRIMARY Change From Baseline to End of Treatment for Body Temperature |
-0.1; 0.0; -0.0 | — |
| PRIMARY Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs) |
3.0; -0.0; -3.0 | — |
| PRIMARY Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs) |
2.0; -2.0; -1.0 | — |
| PRIMARY Change From Baseline to End of Treatment for Pulse Rate (Vital Signs) |
1; -1; 3 | — |
| PRIMARY Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test) |
-0.03; 0.05; -0.01 | — |
| PRIMARY Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test) |
-0.02; 0.10; 0.02 | — |
| PRIMARY Number of Participants Who Developed High Transaminase Values (Clinical Chemistry) |
0; 0; 0 | — |
| PRIMARY Change From Baseline to End of Treatment for Total Protein (Urinalysis) |
-0.02; -0.01; -0.01 | — |
| SECONDARY Plasma Concentration of AZD5069 After 1 Hour of Dosing |
2599.551; 5433.611 | — |
| SECONDARY Area Under the Plasma Concentration Curve of AZD5069 |
29600; 38800 | — |
| SECONDARY Maximum Plasma Concentration for AZD5069 |
2550; 3340 | — |
| SECONDARY Time to Maximum Plasma Concentration for AZD5069 |
1.56; 1.56 | — |
| SECONDARY Maximum Reduction of Circulating Neutrophils in Blood, From Baseline |
1.324; 2.759; 2.678 | — |
Summary
The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of COPD with symptoms for more than one year before screening
- Body mass index of 18-30 kg/m2 and weight of 50-100kg
- Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for one year) at screening
- FEV1 of 30% or above and less than 80% of the predicted normal value post-bronchodilator at screening
- FEV1/FVC less than 70% post-bronchodilator at screening
Exclusion Criteria
- Any clinically significant disease or disorder
- Exacerbation of COPD which was not resolved within 30 days of first dosing
- Patients who have received live or live-attenuated vaccine in the 2 weeks prior to first dosing
- Asthma and any current respiratory tract disorder other than COPD which is considered to be clinically significant
- Disease history suggesting reduced or abnormal immune function other than that related to COPD
Data sourced from ClinicalTrials.gov (NCT01233232). 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.