The therapeutic activity and tolerability of sobrerol, a muco-active agent, were evaluated in 30 children (aged 5–10 years) with secretory otitis media. The drug was administered once daily by inhalation for 10 days consecutively at a dose of 40 mg/3 ml. Clinical assessments showed a significant improvement in the objective measures together with good tolerability. Moreover, sobrerol was shown to improve impedance values; this is an important aspect of the modifications induced by this drug in diseases involving the ear.
PassaliD: Ambroxol in the treatment of serous otitis media. Double-blind multicenter trial. Lung Respir1985; 2: 7–10.
2.
BragaPCDe AngelisLScaglioneF: Pharmacokinetics of sobrerol in chronic bronchitis. Eur J Clin Pharmacol1983; 24: 209–215.
3.
Dalla ValleVCellariCScuriR: Nuovo metodo per la sintesi del d,1-trans-sobrerolo. Atti Accad Med Lomb1973; 28: 28–51.
4.
AllegraLBossiRBragaPC: Action of sobrerol on mucociliary transport. Respiration1981; 42: 105–109.
5.
BragaPC: MacRophotographic evidence of the activity of sobrerol on mucociliary activity in the frog's palate. Clin Trials J1981; 18: 30–38.
6.
PozziELuisettiMColomboML: Sobrerol and chronic bronchitis: new elements suggesting unrecognized potential advantages. Int J Clin Pharmacol Res1986; 6 (suppl 1): 11–17.
7.
SeiditaFDeianaMCaredduP: Acute bronchial diseases in paediatrics: therapeutic approach with sobrerol granules. Ital J Chest Dis1984; 38: 191–194.
8.
BisettiAFumagalliGMarianiB: Multicenter trial on the efficacy of sobrerol in the management of airway catarrhal diseases. Ital J Chest Dis 1982: 4: 257–272.
9.
DenasSMPeretzAPhippsRJ: Effects of chronic sobrerol therapy on transepithelial fluxes of ions and water, and secretion of macromolecules in sheep trachea. Bull Eur Physiopathol Respir1987; 23: 401–407.
10.
GunellaGDel BufaloC: Raffronto dell'azione mucolitica del sobrerolo e della N-acetilcisteina nelle broncopneumopatie croniche. Riv Patol Clin Tubercol Pneumol1982; 53: 583–606.
11.
KarchFESmithCLKerznerB: Adverse drug reactions. A matter of opinion. Clin Pharmacol Ther1976; 19: 489–496.
12.
KarchFELasagnaL: Adverse drug reactions. J Am Med Assoc1975; 234: 1236–1241.
13.
SiegelS: Nonparametric Statistics for the Behavioural Sciences.New York: McGraw-Hill, 1956.
14.
CastiglioniCLGramoliniC: Effect of long-term treatment with sobrerol on the exacerbations of chronic bronchitis. Respiration1986; 50: 202–217.
15.
BragaPCAllegraLBossiR: Review of sobrerol as a muco-modifying drug: experimental data and clinical findings in hypersecretory bronchopulmonary diseases. Int J Clin Pharmacol Res1987; 7: 381–400.
16.
PassaliDZavattiniG: Multicenter study on the treatment of secretory otitis media with ambroxol. Respiration1987; 51: 52–59.
17.
PassaliD: L'unita‘ Rino-tubarica.Milan: Centro Ricerche e Studi Amplifon, 1985.
18.
PassaliDDe SetaEBianchini CiampoliM: Trattamento dell'otite media secretiva con serratiopeptidasi. Studio clinico randomizzato in doppio cieco vs placebo. Pediatr Oggi1983; 3: 367–378.