Study design (if review, criteria of inclusion for studies)
randomized, double-blind, placebo-controlled, crossover trial
Participants
10 ambulant patients with CF (5 females, 5 males), aged 11 to 21 years
Interventions
Each patient received an intravenous dose of theophylline and normal saline over 1/2 hour on consecutive days. The theophylline dose administered was 7.9 +/- 0.4 (mean +/- SD) mg/kg
Outcome measures
Spirometry and whole-body plethysmography were performed at baseline, 1, 3, 5, and 7 h after the theophylline dose, and 10 blood samples were collected over 9 h on both study days. The percent change of PFT from the baseline was recorded. Analysis of variance for balanced two-period crossover design was used to evaluate the effectiveness of theophylline therapy. The serum concentration (Conc.) vs. time data were fitted using nonlinear least-squares regression analysis.
Main results
maximal Conc. (Cmax) of 14.6 +/- 2.7 microgram/ml. The half-life (T1/2), volume of distribution (Vd), and total body clearance (TBC) were 4.9 +/- 1.9 h, 537 +/- 124 mL/kg, and 80 +/- 16 ml/h/kg, respectively.