It has been estimated that 80% of deaths in Cystic Fibrosis patients are caused by pulmonary infections and diseases. Abnormal mucus retention due to incompetent mucus clearing mechanisms is a significant risk factor for which most healthcare providers advise airways clearance techniques (ACT) along with inhaled medications to promote excretion of thinned out mucus.
Physiotherapists suggest a wide variety of different exercises and maneuvers to promote mucus excretion along with medications, nebulizers and inhalers; however, most patients are non-compliant to this complex design of treatment. So far, there is little research to suggest an optimal timing for both ACT and Hypertonic Saline therapy. Research scientists suggested that HTS and ACT performed around the same time is potentially more flexible for most CF patients in terms of saving time, tolerability and perceived efficacy that ultimately improves the compliance towards therapy.
Queen’s University, Belfast is initiating a new clinical trial that would compare the changes in Lung Clearance Index in adult CF patients 90 minutes after:
i- Hypertonic saline therapy followed by airways clearance techniques OR
ii- Hypertonic saline therapy during airways clearance techniques
Lung Clearance Index:
Lung Clearance Index, also known as LCI, is considered a fairly sensitive measure to determine lung abnormal lung functions as opposed to other measures like spirometry. LCI is more frequently used in most clinical trials that aim at ascertaining the efficiency of lung clearance mechanisms in case of interventional strategies.
The Details of This new Cystic Fibrosis Trial:
The study design is a randomized, cross-over one that will compare the results in adult Cystic Fibrosis patients in case of a hospitalization due to a pulmonary exacerbation. The patients will receive ACTs during HTS therapy or ACTs after HTS therapy on Day 10-14 of the hospital stay. Patients will randomly receive one therapy session on one day and reverse session on the other day. Approximately 34 patients will be enrolled in the trial
- The primary outcome measure is 90-minute post treatment Lung Clearance Index (LCI)
- The secondary outcome measure is 24 hour sputum volume, 24 hours post therapy.
University of Ulster researcher Judy M Bradley is the Principal investigator of the trial. The research team is recruiting adults 18 years or older with a positive history of CF. Other inclusion criteria include:
– Positive history of hospital stay for pulmonary exacerbation with at least 10 – 14 days of IV antibiotic therapy
– Patients who can perform Spirometry
– Patients who produce sputum (≥10g over 24 hours) at the time of screening to the day of study
Hypertonic saline is a strong sterile solution of salt-water that upon inhalation improves thinning out of mucus and promotes cough reflex that allow easy excretion of mucus. So far the research conducted in this field is inconclusive as to whether HTS inhalation should be encouraged before or during airway clearing techniques.
This interventional trial hopes to provide some conclusive guidelines that may help in formulating a more functional and tolerable treatment plan in CF patients.