Phase 2
Completed N=74
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Source: ClinicalTrials.gov NCT00758459 ↗Enrolled (actual)
74
Serious AEs
1.4%
Results posted
Aug 2011
Primary outcomePrimary: Incidence of Adverse Events — 13; 17 Participants
Summary
The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
13; 17 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) |
-0.006; 0.003 | — |
| SECONDARY Forced Vital Capacity (FVC) |
-0.048; -0.028 | — |
| SECONDARY Vital Capacity (VC) |
-0.025; -0.043 | — |
| SECONDARY Inspiratory Capacity (IC) |
-0.083; 0.053 | — |
| SECONDARY Forced Expiratory Flow (FEF)25-75% |
-0.073; 0.010 | — |
| SECONDARY Peak Expiratory Flow (PEF) Morning |
1.45; 7.47 | — |
| SECONDARY Peak Expiratory Flow (PEF) Evening |
7.48; 6.69 | — |
| SECONDARY Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total |
0.373; -0.374 | — |
| SECONDARY Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness |
-0.173; -0.390 | — |
| SECONDARY Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness |
-0.073; -0.212 | — |
| SECONDARY Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score |
-0.200; -0.470 | — |
| SECONDARY Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings |
-0.128; -0.262 | — |
| SECONDARY 6-minute Walk Test |
14.4; 9.68 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of COPD for 1 month
- Men or postmenopausal women
- Spirometry values indicating reduced lung function
- 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
- Use of oral or parenteral glucocorticosteroids within 30 days prior to the study
Data sourced from ClinicalTrials.gov (NCT00758459). 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.