"Although it has been known for several decades that prematurity is associated with low lung function in childhood and adulthood, the treatment for this decreased lung function has remained largely unknown," said Dr. Sailesh Kotecha, a professor at Cardiff University in Wales.
"Our clinical trial addressed this gap in knowledge," he told Reuters Health by email. "The trial showed that inhaled steroids improved percent predicted FEV1 by nearly 8%, but that the combination of inhaled corticosteroids with LABA was superior, improving FEV1 by 14% after 12 weeks compared to placebo inhalers."
He added, "It is now reasonable to treat preterm-born children who have respiratory symptoms or decreased lung function with a trial of combined ICS and LABA."
As reported in JAMA Pediatrics, Dr. Kotecha and his colleagues conducted a double-blind, randomized controlled trial to evaluate ICS and ICS with LABA vs. placebo. Over a two-year period, children between 7 and 12 years of age who had been born at 34 weeks' or shorter gestation, and who did not have significant congenital, cardiopulmonary, or neurodevelopmental abnormalities, were given spirometry and exercise testing, as well as measurement of fractional exhaled nitric oxide before and after treatment, at one pediatric hospital.
Of the 144 children whose FEV1 was less than or equal to 85%, 53 were randomized to receive one of three inhaler treatments: 20 children received fluticasone propionate 50 ug, with placebo; 19 got fluticasone propionate 50 ug, with salmeterol 25 ug; and 14 got placebo.
All treatments were given as two puffs twice daily for 12 weeks, and participants who had received pre-existing ICS treatment underwent washout prior to randomization.
The researchers used analysis of covariance in their calculations and adjusted for sex, gestation, bronchopulmonary dysplasia, intrauterine growth restriction, pretreatment corticosteroid status, pretreatment values, and treatment group. Compared with the placebo group, the post-treatment means for FEV1 were 7.7% (P=0.16) higher in the ICS group and 14.1% (P=0.002) higher in the ICS-LABA group.
While active treatment decreased fractional exhaled nitric oxide and improved post-exercise bronchodilator response, it did not improve exercise capacity.
The only adverse event attributed to inhaler treatment occurred in one child who developed a cough at the start of the treatment.
"This is an important and much needed study, and the results are promising, but further randomized controlled trials with larger numbers would be needed to draw definite conclusions," said Dr. Gangaram G. Akangire, a neonatologist and the associate medical director of the Infant Tracheostomy and Home Ventilator Program at Children's Mercy Kansas City, in Missouri.
"The combination of ICS and LABA may be used in highly selected groups of preterm patients with lung disease after failure of conventional treatment," he told Reuters Health by email.
"The study design is good," said Dr. Akangire, who was not involved in the research. "The biggest weakness of this study is the small number of patients studied."
He also noted that "it is unclear whether the effects of this intervention are sustainable in the long term," and that the "safety of this intervention in terms of long-term outcomes would be another concern."
The study had no commercial funding.
SOURCE: https://bit.ly/32fvoop JAMA Pediatrics, online December 13, 2021.
By Lorraine L. Janeczko
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