Study design (if review, criteria of inclusion for studies)
randomized, crossover double-blind pilot study
Participants
5 young adult patients with CF
Interventions
120 mg of a lipid-extracted bovine surfactant (Alveofact) or placebo was aerosolized topatients over a period of 30 min for five consecutive days.
Outcome measures
aerosolized particles diamter, inhalation tolerability, serum antibody titres against the surfactant proteins-B and -C (SP-B/SP-C), FEV1, FVC
Main results
The sample size had the power of 90% to detect an increase in forced expiratory volume in one second (FEV1) of 15% (p < 0.05). Jet nebulization of surfactant produced particles of which more than 75% were the respirable range (< 5 microns). The inhalations were well tolerated. No changes in serum antibody titres against the surfactant proteins-B and -C (SP-B/SP-C) were observed. No differences in FEV1 and forced vital capacity were found before, and 30 or 90 min after, the inhalation
Authors' conclusions
This pilot study shows no acute or short-term benefits of surfactant inhalation in young adults with cystic fibrosis. However, a beneficial effect of exogenous surfactant cannot be excluded before other reasons for a lack of effect, such as insufficient quantity delivered, inhomogeneous distribution or inhibition of the surfactant in the lungs, have been completely ruled out.