Phase 4
Completed N=660
Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
Source: ClinicalTrials.gov NCT00496470 ↗Enrolled (actual)
660
Serious AEs
4.0%
Results posted
Nov 2012
Primary outcomePrimary: Forced Expiratory Volume in 1 Second (FEV1) Pre-dose — 0.064; -0.001 Liters
Summary
The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1) Pre-dose |
0.064; -0.001 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose |
0.165; 0.042 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose |
0.214; 0.083 | — |
| SECONDARY Forced Vital Capacity (FVC) Pre-dose |
0.07; 0.014 | — |
| SECONDARY Forced Vital Capacity (FVC) 5 Minutes Post-dose |
0.266; 0.106 | — |
| SECONDARY Forced Vital Capacity (FVC) 60 Minutes Post-dose |
0.353; 0.19 | — |
| SECONDARY Inspiratory Capacity (IC) Pre-dose |
0.078; 0.014 | — |
| SECONDARY Inspiratory Capacity (IC) 60 Minutes Post-dose |
0.26; 0.149 | — |
| SECONDARY St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score |
-4.12; -1.99 | — |
| SECONDARY Morning Peak Expiratory Flow (PEF) Pre-dose |
5.12; -3.52 | — |
| SECONDARY Evening Peak Expiratory Flow (PEF) Pre-dose |
2.82; -5.54 | — |
| SECONDARY Morning Peak Expiratory Flow (PEF) 5 Min Post-dose |
16.71; 1.1 | — |
| SECONDARY Morning Peak Expiratory Flow (PEF) 15 Min Post-dose |
20.4; 5.2 | — |
| SECONDARY Morning Diary FEV1 Pre-dose |
0.054; -0.046 | — |
| SECONDARY Evening Diary FEV1, Pre-dose |
0.012; -0.065 | — |
| SECONDARY Morning Diary FEV1, 5 Minutes Post-dose |
0.169; -0.018 | — |
| SECONDARY Morning Diary FEV1, 15 Minutes Post-dose |
0.209; 0.014 | — |
| SECONDARY Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose |
-0.143; -0.006 | — |
| SECONDARY GCSQ Score, 5 Minutes Post-dose |
-0.325; -0.202 | — |
| SECONDARY GCSQ Score, 15 Minutes Post-dose |
-0.404; -0.28 | — |
| SECONDARY Capacity of Day Living in the Morning (CDLM) Score |
0.202; 0.07 | — |
| SECONDARY Use of Rescue Medication, Night |
-0.279; 0.022 | — |
| SECONDARY Use of Rescue Medication, Morning |
-0.417; -0.124 | — |
| SECONDARY Use of Rescue Medication, Day |
-0.745; -0.371 | — |
| SECONDARY Use of Rescue Medication, Total |
-1.024; -0.347 | — |
| SECONDARY COPD Symptoms, Breathing Score |
-0.177; -0.049 | — |
| SECONDARY COPD Symptoms, Sleeping Score |
-0.197; -0.045 | — |
| SECONDARY COPD Symptoms, Chest Score |
-0.184; -0.061 | — |
| SECONDARY COPD Symptoms, Cough Score |
-0.246; -0.079 | — |
| SECONDARY Severe COPD Exacerbations |
25; 61 | — |
| SECONDARY Serum High-sensitivity C-reactive Protein (hsCRP) |
0.91; 0.97 | — |
| SECONDARY Serum Interleukin 6 (IL-6) |
1.0; 1.0 | — |
| SECONDARY Serum Interleukin 8 (IL-8) |
1.0; 1.0 | — |
| SECONDARY Serum Monocyte Chemoattractant Protein-1 (MCP-1) |
0.95; 0.95 | — |
| SECONDARY Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha) |
0.97; 0.98 | — |
| SECONDARY Serum Tumor Necrosis Factor-alpha (TNF-alpha) |
1.0; 1.0 | — |
| SECONDARY Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) |
0.96; 0.99 | — |
Eligibility Criteria
Inclusion Criteria
- >=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1 <=50% of PN
Exclusion Criteria
- Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder
Data sourced from ClinicalTrials.gov (NCT00496470). 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.