Nebulization of a bovine surfactant in cystic fibrosis: a pilot study.
Cystic fibrosis (CF) is a lethal disorder which results in excessive airway secretions and in chronic inflammation of the airways. In vitro and in vivo studies have shown that a lack of surfactant results in the closure of the small airways. In this pilot study, we aimed to determine whether surfactant administered by aerosol might improve lung function on a short-term basis in patients with CF. In a randomized, crossover double-blind pilot study, 120 mg of a lipid-extracted bovine surfactant (Alveofact) or placebo was aerosolized to five young adult patients with CF over a period of 30 min for five consecutive days. 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. 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.
Griese
M
M
Lung Research Group, Kinderpoliklinik, Ludwig-Maximilians University, Munich, Germany.
Bufler
P
P
Teller
J
J
Reinhardt
D
D
D000280:Administration, Inhalation; D000328:Adult; D000336:Aerosols; D018592:Cross-Over Studies; D003550:Cystic Fibrosis / Q000503:physiopathology / Q000628:therapy*; D004311:Double-Blind Method; D006801:Humans; D008055:Lipids / Q000009:adverse effects*; D008297:Male; D010743:Phospholipids; D010865:Pilot Projects; D011663:Pulmonary Surfactants / Q000009:adverse effects*; D015656:Respiratory Mechanics
D000336:Aerosols; D008055:Lipids; D010743:Phospholipids; D011663:Pulmonary Surfactants; C078272:SF-RI 1, bovine surfactant preparation