RecruitingPhase 4ACTRN12611000673943

A Randomised trial of the effect of timing of nebulised hypertonic saline in relation to airway clearance physiotherapy, in people with Cystic Fibrosis lung disease.

Randomised trial of the effect of timing of nebulised hypertonic saline in relation to airway clearance physiotherapy, on subjective efficacy, tolerability and overall satisfaction, and lung function parameters in adults with Cystic Fibrosis lung disease.


Sponsor

Royal Prince Alfred Hospital, SSWAHS

Enrollment

50 participants

Start Date

Dec 1, 2009

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at the best time to inhale hypertonic saline (a salty mist that loosens mucus) in relation to chest physiotherapy (airway clearance exercises) for adults with cystic fibrosis. Hypertonic saline can be inhaled before, during, or after the physiotherapy session, but it is not known which timing gives the best results for lung function and comfort. Participants will try all three timings and report their preference and experience. You may be eligible if: - You are 18 years of age or older - You have a confirmed diagnosis of cystic fibrosis - Your lung function is within 10% of your personal best in the past 6 months You may NOT be eligible if: - You are colonised with Burkholderia cepacia (a particularly dangerous lung bacterium in CF) - You have had a major episode of coughing up blood in the past month - You have had a previous lung transplant - You have a low platelet count (thrombocytopaenia) - You are pregnant or at risk of becoming pregnant Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 bronch

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.


Locations(1)

Australia

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ACTRN12611000673943


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