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Clinical Investigations: ASTHMA |

Lung Deposition of Hydrofluoroalkane-134a Beclomethasone Is Greater Than That of Chlorofluorocarbon Fluticasone and Chlorofluorocarbon Beclomethasone*: A Cross-over Study in Healthy Volunteers

Chet L. Leach, PhD; Patricia J. Davidson, MS; Bruce E. Hasselquist, PhD; Robert J. Boudreau, MD, PhD
Author and Funding Information

*From 3M Pharmaceuticals (Dr. Leach and Ms. Davidson), St. Paul; and the Department of Radiology (Drs. Hasselquist and Boudreau), University of Minnesota, Minneapolis, MN.

Correspondence to: Chet L. Leach, PhD, Inhale Therapeutic Systems, 150 Industrial Rd, San Carlos, CA 94070-6256; e-mail: cleach@inhale.com



Chest. 2002;122(2):510-516. doi:10.1378/chest.122.2.510
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Study objectives: To compare the lung deposition of radiolabeled hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) with chlorofluorocarbon fluticasone propionate (CFC-FP) and chlorofluorocarbon beclomethasone (CFC-BDP).

Design: Six-day, open-label, nonrandomized, crossover study.

Setting: Clinical research laboratory.

Participants: Nine healthy, nonsmoking, adult volunteers.

Interventions: On each study day, participants inhaled one or two puffs of 99mTc-labeled HFA-BDP, CFC-FP, or CFC-BDP. All products delivered 50 μg per puff ex-valve. Subjects used a respiratory training and monitoring device to meet predefined, standardized inhalation patterns. Immediately after inhalation of radiolabeled study drug, planar gamma camera images were obtained.

Measurements and results: Radiolabeled HFA-BDP had a higher deposition in the lungs (53% ex-actuator) compared with CFC-FP (12 to 13%) and CFC-BDP (4%). Conversely, CFC-FP and CFC-BDP had a much higher distribution to the oropharynx (72 to 78%, and 82%, respectively) than HFA-BDP (29%). HFA-BDP was deposited evenly throughout the lungs, while CFC-FP and CFC-BDP deposition was primarily in the large central and intermediate airways. Andersen particle size sampling gave mass median aerodynamic diameters for HFA-BDP, CFC-FP, and CFC-BDP of 0.9 μm, 2.0 μm, and 3.5 μm, respectively.

Conclusions: Lung deposition was greater with HFA-BDP compared with CFC-FP and CFC-BDP. Deposition values appeared to be related to the particle size distribution of each inhaler, with the smaller particles of HFA-BDP providing the greatest lung deposition and least oropharyngeal deposition.

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