americanpharmaceuticalreviewNovember 30, 2018
Tag: PARI , SHIP Study , CF , GMP
A recent study in preschoolers with cystic fibrosis (CF) conducted by Cystic Fibrosis Foundation Therapeutics used PARI's LC Sprint Jr. nebulizer, Vios PRO compressor, and PARI's 7% hypertonic saline. The study called SHIP (Saline Hypertonic in Preschoolers) showed that PARI's 7% hypertonic saline inhaled twice daily using the PARI LC Sprint Jr. and the Vios PRO compressor resulted in a sustained and significant improvement in a lung function test called the lung clearance index over 48 weeks.
"PARI was the first company in the USA to receive clearance to market by the FDA for hypertonic saline 7% inhalation solution in unit-dose form, which includes production under Good Manufacturing Practice (GMP) conditions to ensure consistency. 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, director of medical science at PARI.
The results from the SHIP study were presented last month at the North American Cystic Fibrosis Conference in Denver, CO. The study compared nebulized 7% hypertonic saline to 0.9% isotonic saline in children 3-5 years of age with CF. The study found that nebulized 7% hypertonic saline after pre-treatment with albuterol significantly improved the lung clearance index over 48 weeks compared to 0.9% saline (the control agent).
Hypertonic saline is commonly used by people with CF to help thin mucus in the lungs and promote airway clearance.
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