Phase 2
Completed N=52
Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients
Source: ClinicalTrials.gov NCT01054170 ↗Enrolled (actual)
52
Serious AEs
1.9%
Results posted
Jul 2012
Primary outcomePrimary: AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm) — 3.84; 3.83 mm
Summary
The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm) |
3.84; 3.83 | — |
| SECONDARY 5th Generation Wall Area Percentage |
66.21; 65.94 | — |
| SECONDARY Air Trapping Index (ATI) on Expiratory Scans |
54.56; 57.12 | — |
| SECONDARY Pre-bronchodilator Inspiratory Capacity (IC) |
2.56; 2.39 | — |
| SECONDARY Pre-bronchodilator Total Lung Capacity (TLC) |
7.03; 6.92 | — |
| SECONDARY Pre-bronchodilator Functional Residual Capacity (FRC) |
4.41; 4.21 | — |
| SECONDARY Pre-bronchodilator Residual Volume (RV) |
3.64; 3.73 | — |
| SECONDARY Pre-bronchodilator Specific Airway Conductance (SGaw) |
0.52; 0.48 | — |
| SECONDARY Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco) |
5.49; 5.67 | — |
| SECONDARY Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) |
1.51; 1.49 | — |
| SECONDARY Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) |
1.60; 1.58 | — |
| SECONDARY Pre-bronchodilator Forced Vital Capacity (FVC) |
3.25; 3.14 | — |
| SECONDARY Post-bronchodilator Forced Vital Capacity (FVC) |
3.34; 3.34 | — |
| SECONDARY Pre-bronchodilator Slow Vital Capacity (SVC) |
3.42; 3.38 | — |
| SECONDARY Post-bronchodilator Slow Vital Capacity (SVC) |
3.56; 3.44 | — |
| SECONDARY Peak Expiratory Flow (PEF) Morning (Daily Recordings) |
255.82; 244.16 | — |
| SECONDARY Peak Expiratory Flow (PEF) Evening (Daily Recordings) |
264.15; 254.31 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings) |
1.49; 1.29 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings) |
1.51; 1.30 | — |
| SECONDARY Breathlessness, Cough and Sputum Scale (BCSS) Total Score |
2.33; 3.36 | — |
| SECONDARY EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score |
28.48; 33.26 | — |
| SECONDARY St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score |
35.64; 39.61 | — |
| SECONDARY Percentage of Reliever Free Days in Last Six Weeks of Treatment |
34.23; 26.43 | — |
| SECONDARY Exacerbations |
0; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of COPD with symptoms over 1 year
- FEV1/FVC = 40 and < =70 % of predicted post-bronchodilator
- Ex-smokers for at least 12 months
Exclusion Criteria
- Past history or current evidence of clinically significant heart disease
- Current diagnosis of asthma
- Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
Data sourced from ClinicalTrials.gov (NCT01054170). 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.