None listed
Conditions
Brief summary
Research question: To determine whether the timing of HS inhalation (before, during or after airway clearance physiotherapy) impacts the subjective efficacy, tolerability and overall satisfaction, or lung function parameters in adults with cystic fibrosis
Interventions
Following consent, subjects will be randomised to three timing regimes of 6% hypertonic saline (HS) inhalation over three days. Each day subjects will perform baseline spirometry, inhalation of bronchodilator, and inhalation of HS: either immediatly pre (not greater than 30 minutes pre), during (blocks of 10-15 breaths intersperced with airway clearance physiotherapy) or post (not greater than 30 minutes post) airway clearance physiotherapy in random order. The three inhalation regimes will be carried out over three consecutive days (no washout) at the end of a hospital admission when clinical signs have stabilised. The timing regime for that day will be performed for each airway clearance physiotherapy session. Participants will perform their usual daily number of airway clearance sessions (1-3), the same number will be performed on each of the study days. Each HS inhalation will be 4mLs (usually 15-20 minutes to deliver). Each airway clearance physiotherapy session will be 20-40 minutes with the duration for that participant similar for the three days. A post treatment spirometry will be performed two hours post baseline spirometry each day and a VAS completed regarding ease of expectoration, tolerability and overall satisfaction for this order of inhalation and aiway clearance. The spirometry readings will be recorded with the afternoon physiotherapy treatment. Thus the pre and post spirometry readings are two hours apart at a similar time of the day on each of the study days.
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion Criteria: provides informed consent; diagnosis of CF (sweat test or genotyping); Greater than or equal to 18 yrs; FEV1 within 10% of best FEV1 in the previous 6 months
Exclusion criteria
Exclusion Criteria: colonisation with B. cepacia;; major hemoptysis in the preceeding month; previous lung transplant; thrombocytopaenia; pregnancy or at risk of pregnancy.