Laboratory protocol for exercise asthma to evaluate salbutamol given by two devices

• Published in: Medicine and science in sports and exercise Vol. 33; no. 6; pp. 893 - 900
• Main Authors: ANDERSON, Sandra D, LAMBERT, Stephen, BRANNAN, John D, WOOD, Robert J, KOSKELA, Heikki, MORTON, Alan R, FITCH, Kenneth D
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 01-06-2001
• Subjects: Administration, Inhalation; Adult; Albuterol - administration & dosage; Albuterol - pharmacology; Asthma, Exercise-Induced - prevention & control; Biological and medical sciences; Bronchial Provocation Tests - methods; Double-Blind Method; Female; Heart Rate; Humans; Male; Medical sciences; Nebulizers and Vaporizers; Pharmacology. Drug treatments; Respiration; Respiratory system; Space life sciences; Therapeutic Equivalency; Treatment Outcome; Physical exercise; Human; Laboratory study; Bioequivalence; Respiratory disease; Bronchodilator; Bicycle ergometer; Asthma; Experimental disease; Treatment; Salbutamol; Obstructive pulmonary disease; Dry air; Hyperpnea; Protection
• ISSN: 0195-9131; 1530-0315
• DOI: 10.1097/00005768-200106000-00007

As new delivery devices and formulations are being introduced for drugs given by inhalation, there is a need to evaluate their equivalence with old preparations. One way to do this is to investigate their equivalence in protecting from exercise-induced asthma (EIA).
We used a protocol for EIA to compare the protective effect of salbutamol delivered by the pressurised metered dose inhaler (pMDI) and the new Diskus dry powder device. Twenty-seven asthmatic subjects with moderately severe EIA completed an exercise test on four separate days at two study centers. Exercise was performed by cycling for 8 min while inhaling dry air (0% RH, 20-24 degrees C). The target workload in W was predicted as (53.76 x predicted FEV1) - 11.07 and 95% of this target was achieved at 4 min of exercise. This target was chosen in order to achieve ventilation between 50 and 60% of predicted maximum in the last 4 min.
There was no significant difference in the workload, ventilation, or heart rate achieved on the study days. The severity of EIA was measured as the % fall in FEV1. EIA severity was similar on the placebo and control day and the coefficient of variation was 19.4%. The mean +/- SD % fall on the control, placebo, salbutamol by Diskus, and pMDI were 42.0% +/- 15, 39.4% +/-17.6, 13.4% +/- 13.2, and 8.5% +/- 13.8, respectively. Salbutamol significantly inhibited the % fall in FEV1 after exercise, and there was no difference between the preparations.
The protocol described here is suitable for evaluating equivalence of salbutamol preparations in protecting against EIA and could be used to evaluate the protective effect of other medications.