Randomized Comparison of Two Spacer Devices in Subjects with Reversible Airflow Limitation

Abstract

OBJECTIVE: To assess a new spacer device. the ACE. by comparing it with the Aerochamber in subjects with reversible airflow limilation and assessing the change in lung function after inhaled bronchodilator.DESIGN: A randomized single-blind cross-over trial was performed.SETTING: Hospital-based pulmonary function laboratory. POPULATION STUDIED: Thirty subjects with reversible airflow limitation. Mean forced expired volume in Is (FEV₁) was 1.37 L. range O.8 to 3.3 L. All subjects had previously shown at least 15% reversibility after inhaled bronchodilator. All inhaled bronchodilators were witheld for 6 h. Subjects were studied on two separate days. Four subjects were excluded from the final analysis because baseline FEV₁ varied by greater than 10% between the two study days. Maximum expiratory fow rates were used as the primary outcome measure· Change in heart rate was assessed for adverse effects.INTERVENTIONS: The change in maximum expiratory flow rates was assessed 15 mins after two, three and four pulls of inhaled salbutamol delivered via one or the spacer devices. The use of spacer was randomized.RESULTS: Data from 26 subjects were analyzed. Baseline FEV₁ was similar on the two study days: 1.37±0.13 L (ACE) and 1.38±0.14 L. (Aerochamber). The change in FEV₁ was similar on both study days. The change in all the maximum expiratory flow rates was similar with both spacer devices. FEV₁ after four pulls of salbutamol was 1.7±0.16 L. (ACE) and I.71 ±0.16 L (Aerochamber).CONCLUSION: The bronchodilation achieved was similar with both spacers. Because the ACE is cheaper. it may offer cost savings to individuals or institutions.