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A Comparison of the Bronchodilating Activity of Symbicort Pressure Metered Dose Inhaler (pMDI) 160/4.5 Used in the Conventional Manner and With a Valved Spacer Holding Chamber (Aerochamber Plus) (WSMR2)
This study will compare the amount of bronchial tube relaxation from the Formoterol medicine contained in the Symbicort pressure Metered Dose Inhaler(pMDI)(a combination of Budesonide, a steroid, and Formoterol, a drug which relaxes the bronchial smooth muscle. The comparison will be using the pMDI in the usual fashion to the pMDIs and a spacer which allows more time for breathing in the medication. Breathing tests will be measured over a 12 hour period for the comparison.
Details
| Lead sponsor | Western Sky Medical Research |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 16 |
| Start date | 2009-07 |
| Completion | 2009-08 |
Conditions
- Asthma
Interventions
- pMDI budesonide/formotrol 160/4.5 is in group 1
- Symbicort 160/4.5 plus Aerochamber Plus included in group 2
Primary outcomes
- The Mean Area Under the Curve (AUC) of Forced Expiratory Volume in One Second (FEV-1) Over 12 Hours, Measured (BL), 5, 10, 15, 60, 120, 240, 480, 720 Minutes. The Unit is Liters, and the AUC is in Liters. — BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs)
The mean FEV-1 (Forced Expiratory Volume 1 second) for each of the treatments (with and without valved holding chamber) in this crossover design were recorded at BL, 5, 10, 15, 30, 60, 120, 240. 480, 720 minutes (12 hrs) were plotted as a curve and the area under the curve was calculated. The measured results was mean liters/12 hours.
Countries
United States