Clinical trial NCT00915538: Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Formoterol
Long Acting Beta Adrenergic Bronchodilator
Symbicort
Aerochamber
Lead sponsor: Western Sky Medical Research
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2009-06-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed description: Sixteen subjects will receive treatment in a cross-over design. They will inhale Symbicort 160/4.5 two inhalations in the manner prescribed in the approved package insert. The second intervention will be the inhalation of Symbicort 160/4.5 two inhalations through a valved holding chamber (Aero Chamber Plus). Breathing tests including spirometry will be measured at various time periods over a 12-hour time frame in each intervention. Comparison will be made of the two periods to demonstrate that the use of the valved holding chamber does not adversely affect the bronchodilation of the formoterol component of the combination drug.

Eligibility criteria: Inclusion Criteria:

* Asthma with 15% or more increase in Forced expiratory volume at 1 second (FEV-1) after 180-360 mcg of albuterol pMDI

Exclusion Criteria:

* Any illness or condition which might place subject at risk in the study;e.g. some cardiovascular disorders Inability to understand and sign informed consent

Primary outcomes:
measure: 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.
timeFrame: BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs)
Secondary outcomes:
measure: FEV-1/FVC
timeFrame: 0,5,10,15,30,60,120,240,480,720 minutes
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
Study officials:
affiliation: Western Sky Medical Research
name: Lyndon E Mansfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Newman SP. Principles of metered-dose inhaler design. Respir Care. 2005 Sep;50(9):1177-90.
citation: Hess DR. Aerosol delivery devices in the treatment of asthma. Respir Care. 2008 Jun;53(6):699-723; discussion 723-5.
citation: 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.