Study design (if review, criteria of inclusion for studies)
Randomised, double-blind parallel design trial over 6 days.
Participants
The published paper stated that there were no withdrawals. 20 adults (over 18 years of age) with stable stage CF, FVC 35 % - 75 % predicted and non-smokers.
Interventions
Comparison of 2.5 mg nebulized dornase alfa (n = 10) versus placebo (n = 10) bd.
Outcome measures
Included in this review: mean change in % predicted FVC and FEV1, not included: aerosol distribution homogeneity, changes in mucociliary clearance and changes in cough frequency. Measurements were taken on day 6 only and reported in the paper.
Main results
Compared with baseline, there were no statistically significant differences between the two study groups by Day 6 for indices of airflow obstruction obtained from gamma-camera images of the right lung following inhalation of 99mTc aerosol, or for mucociliary clearance or the rate of clearance of the radioaerosol, quantified over a 6-h period. By Day 6, FEV1 and FVC were significantly higher in the rhDNase-treated group than in the placebo group, increasing by an average of 9.4 +/- 3.5% and 12.7 +/- 2.6%, respectively, as compared with a decrease of 1.8 +/- 1.7% and an increase of 0.4 +/- 1.1%, respectively (p < 0.05). There was no significant change in the FEV1/FVC ratio on Day 6 (0.68 +/- 0.05) compared with baseline (0.70 +/- 0.05) in the rhDNase group. On Day 6, FEV1 and FVC decreased after CPT in both study groups, but the decreases were not significant. Our results indicate that aerosolized rhDNase improves FEV1 and FVC independent of CPT.
Keywords: Adolescent; Adult; Artificial Ventilation; Deoxyribonuclease; Inhalation OR nebulised; non pharmacological intervention - devices OR physiotherapy; pharmacological_intervention; Recombinant Proteins; Ventilators; Airway clearance drugs -expectorants- mucolytic- mucociliary-; Respiratory System Agents; Dornase alpha; Pulmozyme;