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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

Abstract

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 

Abbreviations

CF

cystic fibrosis

NAC

N-acetylcysteine

Rsaw

airways resistance

FRC

functional residual capacity

TGV

thoracic gas volume

ERV

expiratory reserve volume

IVC

inspiratory vital capacity

sRaw

specific airways resistance

sGaw

specific conductance

RV

residual volume

MEFV

maximal expiratory flow volume

FEV1

forced expiratory volume in 1 s

FVC

forced vital capacity

PEFR

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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