drugset / Trial / NCT01760304
Changes in Cardiac Function in COPD Patients After Administration of Budesonide/Formoterol (Symbicort®) Versus Placebo
RandomizedCrossoverQuadruple-blindTreatment
Summary
To investigate whether Budesonide/Formoterol (Symbicort ®) therapy can improve heart function at rest by decreasing lung hyperinflation in patients with COPD (Chronic Obstructive Pulmonary Disease).
Timeline
- Start
- 2012-01
- Primary completion
- 2012-07
- Completion
- 2012-10
Outcome
Missed primary endpoint
Stopped: “Sponsor decided to stop the study due to expiration of blinded placebo .”
registry analysis (superiority test); Budesonide / Formoterol; p = 0.769; 2-sided paired t-test NCT01760304 ↗
registry MEAN Budesonide / Formoterol: -0.1 (-1.1 to 0.8) ml/beat NCT01760304 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 160 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 4.5 ug | Inhaled |