Article Text
Abstract
Background Streamlining the timing of treatments in cystic fibrosis (CF) is important to optimise adherence while ensuring efficacy. The optimal timing of treatment with hypertonic saline (HTS) and airway clearance techniques (ACT) is unknown.
Objectives This study hypothesised that HTS before ACT would be more effective than HTS during ACT as measured by Lung Clearance Index (LCI).
Methods Adults with CF providing written informed consent were randomised to a crossover trial of HTS before ACT or HTS during ACT on consecutive days. ACT treatment consisted of Acapella Duet. Patients completed LCI and spirometry at baseline and 90 min post treatment. Mean difference (MD) and 95% CIs were reported.
Results 13 subjects completed the study (mean (SD) age 33 (12) years, forced expiratory volume in 1second % (FEV1%) predicted 51% (22), LCI (no. turnovers) 14 (4)). Comparing the two treatments (HTS before ACT vs HTS during ACT), the change from baseline to 90 min post treatment in LCI (MD (95% CI) −0.02 (−0.63 to 0.59)) and FEV1% predicted (MD (95% CI) −0.25 (−2.50 to 1.99)) was not significant. There was no difference in sputum weight (MD (95% CI) −3.0 (−14.9 to 8.9)), patient perceived ease of clearance (MD (95% CI) 0.4 (−0.6 to 1.3) or satisfaction (MD (95% CI) 0.4 (−0.6 to 1.5)). The time taken for HTS during ACT was significantly shorter (MD (95% CI) 14.7 (9.8 to 19.6)).
Conclusions In this pilot study, HTS before ACT was no more effective than HTS during ACT as measured by LCI.
Trial registration number NCT01753869; Pre-results.
- Cystic Fibrosis
- Respiratory Measurement
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Footnotes
Contributors KO'N, FM, MMT, JSE and JMB conceived and designed research; KO'N, FM and JMB recruited patients, performed treatment, collected clinical data and performed the assessments; KO'N, FM, MMT, IB, JSE and JMB analysed data; DGD and JR provided intellectual contributions; KO'N, FM, JMB, MMT and JSE wrote the paper.
Funding This work was supported by Forest Laboratories Europe.
Competing interests None declared.
Ethics approval This study was approved by the Office for Research Ethics Committees Northern Ireland (REC reference number 12/NI/0153).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.