Azelastine in the Prophylactic Treatment of Bronchial Asthma: An Italian Multicentre Comparison with Ketotifen

Author:

Ambrosi L.1,Bariffi F.2,Carino M.1,Catena E.3,Ceccarelli G.4,Ciampini M.4,Condoluci M.5,Crimi N.6,Ferretti G.7,Gambaro G.8,Girbino G.5,Marchioni F.G.9,Marzo C.3,Maselli R.3,Mattiello A.2,Mistretta A.6,Muratori M.9,Palermo B.6,Panzera F.10,Piacenza G.7,Pinizzotto G.10,Robuschi M.8,Russo P.10,Sanduzzi A.2,Spagnotto S.8,Valenti S.11,Viggiani P.12,Zanon P.12

Affiliation:

1. Clinica del Lavoro’ Foundation, Medical Centre of Cassano Murge, Cassano Murge (Bari), Italy

2. Respiratory Diseases Clinic, Second Faculty of Medicine, University of Naples, Naples, Italy

3. Respiratory Diseases Institute, First Faculty of Medicine, University of Naples, Naples, Italy

4. Medical Department, Farmades SpA, Rome, Italy

5. Respiratory Diseases Institute, University of Messina, Messina, Italy

6. Respiratory Diseases Institute, University of Catania, Catania, Italy

7. Pneumology Division, City Hospital of Alessandria, Alessandria, Italy

8. Respiratory Diseases Institute, University of Milan, Milan, Italy

9. Respiratory Diseases Institute, University of Modena, Modena, Italy

10. Occupational Medicine Institute, University of Messina, Messina, Italy

11. Tuberculosis Clinic, University of Genoa, Genoa, Italy

12. Tuberculosis Clinic, University of Pavia, Pavia, Italy

Abstract

The prophylactic effectiveness of the phthalazinone derivative, azelastine was compared with ketotifen. A total of 111 patients, aged 18 – 65 years, from 10 centres was entered into this randomized, double-blind study. All patients had reversible asthma. After 1 week on placebo, patients were allocated to either 8 mg/day azelastine once or twice daily, or to 1 mg ketotifen, twice daily, for a further 12 weeks. Azelastine was more effective in improving respiratory function (forced expiratory flow in 1 s and peak expiratory flow rate) when given in the once daily regimen, whereas clinical measures (number of weekly asthma attacks) were most improved by twice daily dosing. There was no significant difference between the effectiveness of azelastine and that of ketotifen. Treatments were equally well tolerated and a low incidence of side-effects was reported. In conclusion, 8 mg/day azelastine, in either a single or twice daily dosage regimen may be regarded as providing effective prophylaxis against bronchial asthma.

Publisher

SAGE Publications

Subject

Biochemistry (medical),Cell Biology,Biochemistry,General Medicine

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