title: High resolution computerized tomography of the chest and pulmonary function testing in evaluating the effect of tobramycin solution for inhalation in cystic fibrosis patients.
abstract: To evaluate the sensitivity of high-resolution computerized tomography (HRCT) of the chest compared to spirometry measures in evaluating the effects of tobramycin solution for inhalation (TSI) in cystic fibrosis (CF) patients.Thirty-two subjects >/=6 years old with mild to moderate CF lung disease were enrolled in a randomized, double-blind, placebo-controlled pilot study. Duration was 28 days; 31 subjects completed the study.HRCT scores decreased 4.06 +/- 3.20 (mean +/- SD) for TSI and decreased 0.17 +/- 1.78 for placebo subjects (P = 0.13). Mean forced expiratory flow during middle half of forced vital capacity (FEF(25%-75%)) predicted increased 6.08 +/- 4.86 for TSI and decreased 0.60 +/- 2.34 for placebo (P = 0.23). Percentage forced expiratory volume in 1 s (FEV(1)) predicted increased slightly for both TSI and placebo (1.29 +/- 3.33 for TSI and 1.17 +/- 1.4 for placebo) (P = 0.97). Two of eight HRCT component scores (atelectasis and inhomogeneity) were observed to be highly discordant with observed HRCT global total score and other HRCT component scores. A modified total score was calculated by dropping them from the global total score. The modified HRCT total scores decreased 6.68 +/- 3.09 for TSI subjects and increased 0.02 +/- 2.0 for the placebo subjects (P = 0.07). Sample sizes were calculated to show statistical significance by differences in modified total HRCT scores, global total HRCT scores, FEF(25%-75%) predicted or FEV(1) % predicted. A total of 60, 100, 200, and over 800 patients would be necessary respectively.HRCT can be a useful measure of change in CF pulmonary disease, requiring a smaller sample size than that required to show treatment effect by pulmonary function testing (PFT) alone.
authors.affiliation: Department of Pediatrics, Division of Pediatric Pulmonology, University of Michigan Health System, Ann Arbor, Michigan, USA. snasr@umich.edu
authors.forename: Samya Z
authors.initials: SZ
authors.lastname: Nasr
authors.forename: Diane
authors.initials: D
authors.lastname: Gordon
authors.forename: Ermelinda
authors.initials: E
authors.lastname: Sakmar
authors.forename: Xin
authors.initials: X
authors.lastname: Yu
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Christodoulou
authors.forename: Boris P
authors.initials: BP
authors.lastname: Eckhardt
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Strouse
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002648:Child; D003550:Cystic Fibrosis / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005540:Forced Expiratory Flow Rates / Q000502:physiology; D005541:Forced Expiratory Volume / Q000502:physiology*; D006801:Humans; D008297:Male; D010865:Pilot Projects; D013902:Radiography, Thoracic / Q000379:methods*; D012189:Retrospective Studies; D014031:Tobramycin / Q000008:administration & dosage*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D014031:Tobramycin