Phase 3
Completed N=1,293
Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients
Source: ClinicalTrials.gov NCT01069289 ↗Enrolled (actual)
1,293
Serious AEs
6.8%
Results posted
Oct 2012
Primary outcomePrimary: Pre-dose Forced Expiratory Volume in One Second (FEV1) — 104.6; 101.5 percentage of Baseline
Summary
The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-dose Forced Expiratory Volume in One Second (FEV1) |
104.6; 101.5 | — |
| SECONDARY 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1) |
113.9; 111.2 | — |
| SECONDARY Pre-dose Forced Vital Capacity (FVC) |
102.2; 100.9 | — |
| SECONDARY 1 Hour Post-dose Forced Vital Capacity (FVC) |
110.1; 108.7 | — |
| SECONDARY Percentage of Participants With Exacerbations |
11.9; 16.9 | — |
| SECONDARY Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
93; 151 | — |
| SECONDARY Morning Peak Expiratory Flow(PEF) |
4.29; -4.78 | — |
| SECONDARY Evening Peak Expiratory Flow (PEF) |
2.55; -5.13 | — |
| SECONDARY Total Number of Day With Exacerbation |
653; 1098 | — |
| SECONDARY Morning Forced Expiratory Volume in One Second (FEV1) |
0.0244; -0.0312 | — |
| SECONDARY Evening Forced Expiratory Volume in One Second (FEV1) |
0.0176; -0.0324 | — |
| SECONDARY Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms |
-0.20; -0.15 | — |
| SECONDARY Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms |
-0.34; -0.23 | — |
| SECONDARY Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms |
-0.24; -0.24 | — |
| SECONDARY Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score |
-0.78; -0.61 | — |
| SECONDARY Use of Rescue Medication |
-0.51; -0.26 | — |
| SECONDARY St George's Respiratory Questionnaire (SGRQ) Total Score |
-4.37; -2.90 | — |
Eligibility Criteria
Inclusion Criteria
- A current clinical diagnosis of Chronic Obstructive Pulmonary Disease
- Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years
- A smoking history of at least 10 pack years
Exclusion Criteria
- History and/or current clinical diagnosis of asthma
- History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis
Data sourced from ClinicalTrials.gov (NCT01069289). 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.