2012 OPEN FORUM Abstracts
RANDOMIZED DOUBLE-BLIND MONOCENTRIC TRIAL ON TOLERABILITY, ACCEPTABILITY AND EFFICACY OF TWO FORMULATIONS OF INHALED 7% HYPERTONIC SALINE WITH AND WITHOUT HYALURONIC ACID IN REDUCING AIRWAYS INFLAMMATION IN PATIENTS WITH CYSTIC FIBROSIS PRELIMINARY RESULTS.
Anna Brivio1,2, Diana Costantini1, Clara Ceruti1,2, Carla Colombo1; 1IRCCS Fondazione CaGranda Ospedale Maggiore Policlinico, MILANO, Italy; 2ARIR-Associazione Fisioterapisti Insufficienza Respiratoria, MILANO, Italy
Background. In Cystic Fibrosis disturbances in pulmonary epithelial ion transport bring both to a depletion of airway surface liquid (ASL) volume and reduced mucociliary clearance. Nebulized 7% hypertonic saline has been proposed to hydrate airways and restore ASL by inducing osmotic flow of water along lung epithelium and hence improving mucociliary escalator. The aim of the study is to evaluate tolerability and efficacy of one month-inhaled 7% hypertonic saline with and without 0.1% sodium hyaluronate in patients with CF for four weeks treatment. Methods. 26 patients (12men) in clinical stable condition have been enrolled in two groups (7% hypertonic saline vs. 7% hypertonic saline + 0.1% sodium hyaluronate - Hyaneb®). Mean age was 15.7 yrs (range 8 -35, sd 6.8) and FEV1 89.5% pred. (range 46.9 - 117.4 sd 19.7). All patients have been randomized to two different treatment groups. Results. All patients showed a positive response to bronchodilation with short-acting ß2-agonist administered by spacer: FEV1 increased meanly of 5.54% and MMEF25-75 of 6.2%. A mean increase in FEV1 of 3.2% was reported after four weeks treatment but difference between two groups was not statistically significative (p=0.06). FVC did show the same increase of 3.2% without significance (p=0.092). Total pulmonary resistances decreased of 16.9% (p=0.46) and RV decreased of 22.55% (p < 0.05). TLC showed a statistically significative increased of 4.2% (p < 0.02). The impairment of baseline lung function expressed as FEV1 seems to correlate with a fall in residual volume (r=0.4). The VAS indicated and average degree of satisfaction of 5.73 after the first administration. The treatment was completed in 44% of patients; The adherence questionnaire showed that main reasons for not taking prescribed aerosol were lack of time in the morning (36%), fatigue in the evening (28%) and/or duration of aerosol administration (20%). Conclusions. Preliminary data show a positive trend in improved mucociliary clearance and reduced total airways resistances and RV by administration of inhaled 7% hypertonic saline with or without hyaluronic acid. The hypertonic solution shows a good efficacy in reducing airway obstruction and in increasing pulmonary functions parameters in the short-term period, Discomforts from inhalation of hypertonic solutions tend to decrease after four weeks. Sponsored Research - None