CFDB - Cystic Fibrosis DataBase

primary studies published RCT

A double-blind study of the use of acetylcysteine in patients with cystic fibrosis.

Study design (if review, criteria of inclusion for studies)

Single centre in USA. 4-month trial period, participants receiving interventions for 1 month at a time. No washout period. No dropouts. Data was analysed by ITT, however only limited data was presented in the paper. Randomized, double-blind, controlled, cross-over design.

Participants

8 CF participants (3 male). Age range 6 - 22 years (mean 12.6). Clinical status ranged from "excellent" to "moderate" (based on the method of Shwachman and Kulczycki). 4 participants stopped using nebulized isoproterenol, antibiotics, 3% saline during the trial period, whereas the other 4 participants did not alter their pre-trial therapy. None of the participants had ever received NAC before the trial.

Interventions

Nebulized 20% NAC tid, versus nebulized 2% NAC tid.

Outcome measures

Subjective improvement in sputum thickness and ability to expectorate, PFTs (VC, PEF, PIF, E50, FEV1, SBO), adverse reactions.

Keywords: Acetylcysteine; Airway clearance drugs -expectorants- mucolytic- mucociliary-; pharmacological_intervention; thiols; Respiratory System Agents;