Asthma diagnosis and treatmentResponse to inhaled albuterol during nocturnal asthma
Section snippets
Subject selection
Twenty-two subjects (10 females) age 18 to 44 years with a history of nocturnal asthma were selected. During the screening visit, their FEV1 had to meet American Thoracic Society criteria for acceptability and reproducibility13 and had to be ≥60% of predicted.14 To confirm bronchodilator responsiveness, nebulized albuterol (2.5 mg) was administered at 30-minute intervals until FEV1 improved ≥15% and to ≥80% of predicted, or 3 doses had been inhaled. Subjects were excluded if they had any
Results
Of the 22 subjects randomized to treatment, 15 (8 females) age 18 to 37 years completed the study. Five subjects were excluded because they did not wake from asthma symptoms in the CRC. A sixth subject was excluded because of an asthma exacerbation, and a seventh subject was excluded because of the presence of barbiturates in his urine. At the prestudy screening visit, all of the subjects who completed the study had moderate airway obstruction with the capacity to achieve normal or near normal
Discussion
The results of this study indicate that during nocturnal asthma, response to albuterol was slower, was less complete, and required a larger number of puffs to normalize lung function than during the day when subjects had asymptomatic airway obstruction. These differences were most likely a result of the severe airway obstruction on awakening from nocturnal asthma.
Our results are supported by a previous study of epinephrine in 5 subjects with nocturnal asthma. Barnes et al17 found a steeper
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2014, Middleton's Allergy: Principles and Practice: Eighth EditionBioequivalence assessment of inhalation products: Interchangeability, study design and statistical methods
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2008, ChestCitation Excerpt :Inhaled albuterol is the most extensively used medication for patients with asthma. Bronchodilator response to SABAs has been observed to be highly variable between patients.3–9 The results of the present study support these findings and extend them to include quantification of the variability in bronchodilator response using a pharmacodynamic population model.
Supported in part by an investigator-initiated grant from the GlaxoSmithKline Respiratory Research Institute, Research Triangle Park, NC, by a pulmonary fellowship training grant from the American Lung Association, and by the National Institutes of Health General Clinical Research Center Grant #MO1 RR00082.
Disclosure of potential conflict of interest: L. Hendeles has a consultant arrangement with Kos Pharmaceuticals and Medicis Pharmaceuticals, has a stock or other equity ownership in Medicis Pharmaceuticals, receives grants or research support from GlaxoSmithKline, Merck, and Novartis, and is on the speaker's bureau for AstraZeneca, GlaxoSmithKline, Merck, and Novartis. R. Ahrens has consultant arrangements with AstraZeneca, Forest Laboratories, GlaxoSmithKline, IVAX, and Skye Pharma, and receives grants or research support from AstraZeneca and GlaxoSmithKline.