Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus)

Summary

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.

Timeline

Start

2009-07

Primary completion

2009-08

Completion

2009-08

Outcome

Missed primary endpoint

registry Group 1 vs Group 2; p = 0.76; AUC 0.0; t-test, 2 sided NCT00915538 ↗

Publications

• Background Dolovich MB, Ahrens RC, Hess DR, Anderson P, Dhand R, Rau JL, Smaldone GC, Guyatt G; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005 Jan;127(1):335-71. doi: 10.1378/chest.127.1.335.
• Background Newman SP. Principles of metered-dose inhaler design. Respir Care. 2005 Sep;50(9):1177-90.
• Background Hess DR. Aerosol delivery devices in the treatment of asthma. Respir Care. 2008 Jun;53(6):699-723; discussion 723-5.
• Mansfield LE, Maynes R. A valved holding chamber does not decrease the bronchodilator activity of budesonide-formoterol combination metered dose inhaler. J Asthma. 2013 Feb;50(1):71-4. doi: 10.3109/02770903.2012.745093. Epub 2012 Nov 26.

Drugs

Indications