CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Randomized controlled trial of biofilm antimicrobial susceptibility testing in cystic fibrosis patients.

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

RCT

Participants

Inpatient adults with LRTI and abnormal sputum following bilateral sequential lung transplant (LTx)

Interventions

Participants received 5 ml of isotonic saline, or 2.5 ml of dornase alfa, nebulized once daily for 1 month followed by 2 months symptom diary.

Outcome measures

Primary outcome was lung clearance index (LCI2%). Secondary outcomes included spirometry, quality of life, readmission, length of stay, self-reported exacerbations, and adverse events at baseline, 1 and 3 months.

Main results

Thirty-two participated, 16 in each group, baseline mean (SD) FEV1 % 58 (22), median (IQR) length of stay 7 (5) days, time since LTx 3.49 (6.80) years. There were no significant between-group differences in LCI2% at any point (1 month mean difference -0.34, 95% confidence interval (CI) -1.57 to 0.89; 3 months -0.76, 95% CI -2.29 to 0.78, favoring dornase alfa). Secondary outcomes were not different between groups.

Authors' conclusions

These results do not support the routine use of dornase alfa during LRTI in LTx recipients.

Keywords: Adolescent; Child; Deoxyribonuclease; Airway clearance drugs -expectorants- mucolytic- mucociliary-; hydration; Hypertonic Solutions; Infant; Inhalation OR nebulised; nebuliser; pharmacological_intervention; Respiratory System Agents; Dornase alpha; Pulmozyme; Lung Transplantation; transplantation; non pharmacological intervention - surg;