Phase 2
Completed N=66
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT00629239 ↗Enrolled (actual)
66
Serious AEs
3.1%
Results posted
Dec 2010
Primary outcomePrimary: Number of Patients Experiencing Adverse Events — 22; 27 Participants
Summary
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Experiencing Adverse Events |
22; 27 | — |
| SECONDARY Forced Expiratory Volume 1 (FEV1) |
-0.083; -0.149 | — |
| SECONDARY Forced Vital Capacity (FVC) |
-0.044; -0.240 | — |
| SECONDARY Vital Capacity (VC) |
-0.022; -0.022 | — |
| SECONDARY Inspiratory Capacity (IC) |
-0.117; -0.038 | — |
| SECONDARY Forced Expiratory Flow (FEF) 25%-75% |
-0.027; 0.006 | — |
| SECONDARY Peak Expiratory Flow (PEF) Morning |
-9.10; -4.47 | — |
| SECONDARY Peak Expiratory Flow (PEF) Evening |
-12.4; -1.90 | — |
| SECONDARY The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total |
0.250; 0.044 | — |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness |
0.159; -0.007 | — |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness |
0.170; 0.024 | — |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score |
0.064; -0.103 | — |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score |
0.085; 0.000 | — |
| SECONDARY 6-minute Walk Test |
-8.67; -6.67 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of COPD, with symptoms for more than 1 year
- Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
- Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator
Exclusion Criteria
- Clinical suspicion of active tuberculosis
- Any current clinically significant respiratory tract disorder other than COPD
- History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
Data sourced from ClinicalTrials.gov (NCT00629239). 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.