Kids with cystic fibrosis (CF) treated with inhaled hypertonic saline showed significant improvement in lung function, according to the findings presented at North American Cystic Fibrosis Conference (NACFC).
PARI was the first company to obtain clearance from the U.S. Food and Drug Administration (FDA) to market an inhalation solution of 7% hypertonic saline in unit-dose form.
The study specifically used PARI’s 7% hypertonic saline delivered via its LC Sprint Jr. nebulizer and its Vios PRO Compressor, which transforms liquid medication into an aerosol.
In a similar study published in the American Journal of Respiratory and Critical Care Medicine, Medical Dialogues has earlier reported that preventive inhalation with hypertonic saline (HS) initiated in the first months of life is safe and effective in infants with cystic fibrosis (CF).
Hypertonic saline consisted of extra salty, germ-free water able to thin mucus and promote airway clearance in patients with CF. Hypertonic saline is included in the group of mucolytic medications for CF and other respiratory diseases and conditions.
The Saline Hypertonic in Preschoolers (SHIP) study examined the effectiveness of treatment with 7% hypertonic saline against 0.9% isotonic saline, given by jet nebulizer twice daily for about one year (48 weeks) in up to 150 children, ages 3 to 5, with stable CF.
The study participants were pre-treated with the bronchodilator albuterol. After that, they were randomized to either twice daily nebulized 7% hypertonic saline or to a control group given 0.9% isotonic saline — the same salt concentration as found in body fluids.
The investigators found that 7% hypertonic saline led to a sustained and significant improvement in lung function over 48 weeks, compared to controls, as assessed using the lung clearance index test, a measure of ventilation distribution.
“We are pleased that researchers chose PARI’s aerosol delivery devices and hypertonic saline for the SHIP Study and the positive results show that treatment with hypertonic saline can benefit preschoolers with CF,” said Lisa Cambridge, PARI’s director of medical science.
Cystic fibrosis is a progressive, genetic disease that causes persistent lung infections and limits the ability to breathe over time. In people with CF, a defective gene causes a thick, sticky buildup of mucus in the lungs, pancreas, and other organs.