The effectiveness of the short- and long-term use of crystallized theophylline in asthmatic children

J Pediatr. 1978 Apr;92(4):663-7. doi: 10.1016/s0022-3476(78)80318-7.

Abstract

The bioavailability, duration of action, and efficacy of a crystallized tablet form of theophylline were studied in 16 nonsteroid-dependent asthmatic children. All required bronchodilator drugs daily for control of symptoms. Theophylline 125 mg, ephedrine SO4 30 mg, T + E, or placebo were given in a randomized, double-blind, crossover design on four separate days. Pulmonary function tests (FVC, FEV1, FEF25-75) and serum T levels were determined at 0, 4, 1, 2, 4, and 6 hours on both day one and after day 7 of a every-six-hour drug dosage schedule. Mean maximum T levels were achieved at two hours with a peak mean of 2.94 microgram/ml +/- 0.24 SEM on day one. On day 8, the maximum T levels were higher, with a peak mean at two hours of 4.69 microgram/ml +/- 0.49 SEM. Computer analyses for pharmokinetics are compatible with 100% absorption of this preparation. Pulmonary function tests were significantly improved (FEV1 20% and FEF25-75 15%) at T levels of 2 to 5 microgram/ml. Addition of E to the T regimen further improved pulmonary function only on day one and had no effect on the last study day.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Administration, Oral
  • Adolescent
  • Asthma / drug therapy*
  • Biological Availability
  • Child
  • Clinical Trials as Topic
  • Crystallization
  • Double-Blind Method
  • Ephedrine / administration & dosage
  • Ephedrine / therapeutic use
  • Female
  • Forced Expiratory Volume
  • Humans
  • Male
  • Placebos
  • Respiratory Function Tests
  • Theophylline / administration & dosage*
  • Theophylline / blood
  • Theophylline / therapeutic use
  • Time Factors

Substances

  • Placebos
  • Theophylline
  • Ephedrine