Phase 3
Completed N=1,219
A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
Source: ClinicalTrials.gov NCT00419744 ↗Enrolled (actual)
1,219
Serious AEs
17.5%
Results posted
Sep 2010
Primary outcomePrimary: Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year — 0.75; 0.84; 1.14 Exacerbations
Summary
The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year |
0.75; 0.84; 1.14 | — |
| PRIMARY Rate of Exacerbations Per Subject-year |
0.639; 0.745; 1.029 | — |
| SECONDARY Pre-dose Forced Expiratory Volume in 1 Second (FEV1) |
0.07; 0.07; 0.04 | — |
| SECONDARY Morning Peak Expiratory Flow (PEF) |
19.82; 19.61; 15.81 | — |
| SECONDARY Evening PEF |
17.62; 17.77; 14.08 | — |
| SECONDARY Dyspnea Symptom Scores |
-0.30; -0.29; -0.24 | — |
| SECONDARY Use of Rescue Medication |
-1.21; -1.03; -0.28 | — |
| SECONDARY St. George's Respiratory Questionnaire (SGRQ) Score |
-6.23; -5.00; -5.71 | — |
Eligibility Criteria
Inclusion Criteria
- A current clinical diagnosis of COPD with COPD symptoms for more than 2 years
- Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
- A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit
Exclusion Criteria
- A history of asthma at or after 18 years of age
- A history of allergic rhinitis at or after 18 years of age
- Subjects taking oral steroids
- Any significant disease or disorder that may jeopardize a subject's safety
Data sourced from ClinicalTrials.gov (NCT00419744). 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.