Phase 2
Completed N=55
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients
Source: ClinicalTrials.gov NCT00758706 ↗Enrolled (actual)
55
Serious AEs
7.3%
Results posted
Apr 2015
Primary outcomePrimary: Ratio of TNF Alpha at Week 6 to Baseline — 1.37; 1.21 ratio
Summary
The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of TNF Alpha at Week 6 to Baseline |
1.37; 1.21 | — |
| PRIMARY Ratio of Sputum Total Cells at Week 6 to Baseline |
1.07; 0.876 | — |
| PRIMARY Ratio of Total Urine Desmosine at Week 6 to Baseline |
0.946; 1.27 | — |
| SECONDARY Incidence of Adverse Events |
15; 15 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6 |
-0.025; -0.063 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) at Week 6 |
-0.103; -0.104 | — |
| SECONDARY Change From Baseline in Vital Capacity (VC) at Week 6 |
0.098; -0.110 | — |
| SECONDARY Change From Baseline in Inspiratory Capacity (IC) at Week 6 |
-0.082; -0.173 | — |
| SECONDARY Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Week 6 |
-0.007; -0.067 | — |
| SECONDARY Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment |
-9.81; -7.73 | — |
| SECONDARY Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment |
-13.6; -13.5 | — |
| SECONDARY Change From Baseline in Clinical COPD Questionnaire(CCQ) Total |
0.011; -0.241 | — |
| SECONDARY Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment |
-0.191; -0.338 | — |
| SECONDARY Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment |
-0.149; -0.156 | — |
| SECONDARY Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment |
-0.114; -0.324 | — |
| SECONDARY Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment |
0.072; -0.150 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of COPD for 1 month
- Men or postmenopausal women
- Spirometry values indicating symptomatic patients
- Smoking history equivalent to using 20 cigarettes a day for 10 years.
Exclusion Criteria
- Any current respiratory tract disorders other than COPD
- Requirement for regular oxygen therapy
- Acute worsening of COPD (exacerbation) 1, 5 month prior to study drug administration
- Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study
Data sourced from ClinicalTrials.gov (NCT00758706). 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.