Back to Search
Start Over
Randomized, Double‐Blind, Crossover, Clinical‐End‐Point Pilot Study to Examine the Use of Exhaled Nitric Oxide as a Bioassay for Dose Separation of Inhaled Fluticasone Propionate.
- Source :
-
Journal of Clinical Pharmacology . Apr2018, Vol. 58 Issue 4, p448-456. 9p. - Publication Year :
- 2018
-
Abstract
- Abstract: This was a randomized, double‐blind, crossover, clinical‐end‐point pilot study examining the hypothesis that inhaled fluticasone propionate decreases exhaled nitric oxide (eNO) concentrations within a week of beginning treatment and shows evidence of dose separation across the marketed dose range. Subjects had a ≥6‐month history of asthma and screening eNO ≥60 parts per billion. At the start of each treatment period, eNO was ≥55 parts per billion, and forced expiratory volume in 1 second was ≥50% predicted. Subjects attended a clinic visit daily on consecutive mornings during each of 3 1‐week treatment periods to measure eNO and receive once‐daily doses of 100/50, 250/50, or 500/50 fluticasone propionate/salmeterol combination product (Advair® Diskus). Daily eNO value recorded was the highest of 3 measurements; 1 inhalation of treatment was then administered. Procedures were repeated for 3 treatment cycles, separated by 14‐day minimum washouts. A total of 105 subjects were screened; 22 were randomized; and 17 completed all treatments. Mean percentage eNO decrease (standard deviation) from day 1 baseline for each treatment period was 36.6 (±18.7), 45.3 (±16.5), and 54.6 (±12.5) with Advair® 100/50, 250/50, and 500/50, respectively. Mean percentage decrease in eNO across each treatment (dose) was modeled using a mixed‐model ANOVA. Although the overall treatment was significant (<italic>P</italic> = .0015), because of the relatively small sample size and within‐subject variability, only the 100/50 vs 500/50 (<italic>P</italic> = .0003) and 250/50 vs 500/50 (<italic>P</italic> = .047) treatments were significantly different. [ABSTRACT FROM AUTHOR]
- Subjects :
- *ANALYSIS of variance
*BIOLOGICAL assay
*COMBINATION drug therapy
*CROSSOVER trials
*MEDICAL appointments
*NITRIC oxide
*RESPIRATION
*SAMPLE size (Statistics)
*PILOT projects
*RANDOMIZED controlled trials
*TREATMENT effectiveness
*VITAL capacity (Respiration)
*BLIND experiment
*TREATMENT duration
*FLUTICASONE
*SALMETEROL
*THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 00912700
- Volume :
- 58
- Issue :
- 4
- Database :
- Academic Search Index
- Journal :
- Journal of Clinical Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 128708761
- Full Text :
- https://doi.org/10.1002/jcph.1043