Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus) (WSMR2)

Western Sky Medical Research

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: pMDI budesonide/formotrol 160/4.5 is in group 1; Device: Symbicort 160/4.5 plus Aerochamber Plus included in group 2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00915538

WSMR 2008-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group 1 / use of pMDI as approved

Other group

Description:

The intervention in this group will use inhalation from the pMDI containing budesonide/formoterol pMDI 160/4.5 2 inhalations as approved. (FDA approved product information) without a spacer. The pulmonary function tests (PFTs) will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of budesonide /formoterol; pMDI160/5.

Treatment:

Device: Symbicort 160/4.5 plus Aerochamber Plus included in group 2

Drug: pMDI budesonide/formotrol 160/4.5 is in group 1

Group 2 / pMDI with Aerochamber Plus

Experimental group

Description:

The intervention in this group will use the pMDI budesonide/formoterol 160/4.5 with a valve holding chamber spacer device, Aerochamber Plus which is the intervention being studied The PFTs will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of Symbicort 160/5. This is the intervention to be studied for comparison to the non-spacer inhalations..

Treatment:

Device: Symbicort 160/4.5 plus Aerochamber Plus included in group 2

Drug: pMDI budesonide/formotrol 160/4.5 is in group 1