Trial of different concentrations of nebulised saline for cystic fibrosis

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Background People with Cystic Fibrosis (CF) have abnormally slow clearance of mucus from their airways. This causes chronic lung infection with obstruction of the airways by mucus. The chronic lung infection is characterised by (A) periods of acute worsening of the infection known as exacerbations, (B) progressive deterioration in lung function outside periods of exacerbation, (C) reduced quality of life, and (D) reduced ability to exercise. A strong, sterile, salt-water solution known as hypertonic saline is commonly used to assist clearance of mucus from the airways of people with CF. We know that long-term use of hypertonic saline where the concentration of salt is 7% produces significant benefits for people with CF in terms of (A) exacerbations, (B) lung function, and (C) quality of life. Some patients find 7% hypertonic saline difficult or impossible to tolerate. Some of these patients use lower concentrations of saline, although it is not known whether these are as effective, nor even whether they are more effective than doing nothing. Some patients often skip doses of hypertonic saline because the delivery is time consuming. Faster nebulisers are now available. The efficacy and tolerability of hypertonic saline delivered through these new nebulisers have not been formally assessed. Also, hypertonic saline has not been tested in patients with very badly affected lungs. Aim One aim of the study is to determine the benefits of 6% and 3% hypertonic saline when delivered via a new, fast nebuliser, in people with CF. Another important aim is to determine whether hypertonic saline is tolerable when delivered via a fast nebuliser. A final aim is to compare the response to hypertonic saline among those with very badly affected lungs with the response to those with mildly and moderately affected lungs. Method 140 people with CF will be enrolled in the study. For the first time, patients with very badly affected lungs will be eligible to enrol. All will be required to be in a stable clinical condition. At enrolment, lung function, quality of life, and some other relevant measures will be assessed. Participants will then be randomised to inhale either 6%, 3% or 0.9% saline. All other standard care will continue in all groups. Participants will be regularly assessed during the 16-week period over which they will inhale their allocated saline solution, twice a day, via a fast nebuliser. The progress of the groups inhaling the different concentrations of saline will be compared in terms of (A) exacerbations, (B) lung function, (C) quality of life and (D) exercise capacity. The tolerability of the solutions will also be recorded. We will also compare the response to the saline among those with very badly affected lungs to those with milder disease.

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