European Journal of Pediatrics

, Volume 144, Issue 4, pp 374–378 | Cite as

A double-blind placebo controlled trial with oral ambroxol and N-acetylcysteine for mucolytic treatment in cystic fibrosis

  • F. Ratjen
  • R. Wönne
  • H.-G. Posselt
  • B. Stöver
  • D. Hofmann
  • S. W. Bender
Original Investigations


The therapeutic efficacy of oral N-acetylcysteine (NAC) and ambroxol as compared with the effect of placebos was studied in 36 cystic fibrosis (CF) patients with mild to moderate pulmonary disease. The patients were randomly assigned to one of three regimens, matched on the basis of age and Chrispin-Norman scores. The trial was conducted over a period of 12 weeks. Patients were assessed clinically and by extensive pulmonary function techniques (body-plethysmography, maximal expiratory flow-volume curves, trapped air determination). Although no clinical differences could be observed between the three groups, significant impairment in the placebo group was found for trapped air and FEV1 when compared to the active groups, suggesting a therapeutic effect of ambroxol and NAC in CF.

Key words

Cystic fibrosis Ambroxol N-acetylcysteine Pulmonary function test 



cystic fibrosis




airways resistance


functional residual capacity


thoracic gas volume


expiratory reserve volume


inspiratory vital capacity


specific airways resistance


specific conductance


residual volume


maximal expiratory flow volume


forced expiratory volume in 1 s


forced vital capacity


peak expiratory flow rate


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Copyright information

© Springer-Verlag 1985

Authors and Affiliations

  • F. Ratjen
    • 1
  • R. Wönne
    • 1
  • H.-G. Posselt
    • 1
  • B. Stöver
    • 1
  • D. Hofmann
    • 1
  • S. W. Bender
    • 1
  1. 1.Department of PediatricsJohann Wolfgang Goethe-UniversityFrankfurt/M.Federal Republic of Germany

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