Preschoolers with cystic fibrosis (CF) treated with inhaled hypertonic saline in a clinical trial showed significant improvement in lung function, PARI, the company whose solution and equipment was used in the study, reports.
The Saline Hypertonic in Preschoolers (SHIP) study (NCT02378467) 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.
Sponsored by a University of Washington nonprofit center in collaboration with the Cystic Fibrosis Foundation Therapeutics, a subsidiary of Cystic Fibrosis Foundation (CFF), it 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.
Hypertonic saline consists of extra salty, germ-free water able to thin mucus and promote airway clearance in patients with CF. It is also able to restore the liquid layer that lines the airways. Hypertonic saline is included in the group of mucolytic medications for CF and other respiratory diseases and conditions.
Enrolled preschoolers were pre-treated with the bronchodilator albuterol, before being 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.
Results showed 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. Prior studies showed that it correlates with structural lung disease, as well as with lower respiratory tract inflammation and infection.
Findings were presented at the recent North American Cystic Fibrosis Conference (NACFC) in Denver.
“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,” Lisa Cambridge, PARI’s director of medical science, said in a press release.
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, Cambridge added.
The improvement seen in lung function with 7% hypertonic saline is in line with recent data from another study, the Phase 2 trial PRESIS (NCT01619657) in newborns and infants (up to 4 months of age). Published results from this which showed that inhalation of hypertonic saline can help babies with CF to breathe better and relieve disease symptoms.
The solutions and inhalation devices used in the PRESIS study were also provided by PARI.
PARI also develops aerosol delivery systems for patients with asthma, chronic lung disease, hospital-acquired-ventilator-associated pneumonia, and respiratory syncytial virus, a common cause of lung and respiratory tract infections in children.