Advertisement
Research Article| Volume 37, ISSUE 6, P1248-1258, June 01, 2015

Download started.

Ok

Randomized, Multicenter Clinical Study of Tratinterol Hydrochloride Tablets for the Treatment of Bronchial Asthma

      Abstract

      Purpose

      The aim of this study was to determine the efficacy and safety profile of tratinterol hydrochloride tablets in the treatment of bronchial asthma.

      Methods

      This multicenter, randomized, double-blind clinical research study was completed at 6 centers in the People’s Republic of China from March 2009 to June 2010, and a randomized trial of procaterol hydrochloride tablets produced by Otsuka Pharmaceutical Co Ltd was conducted. The study was approved by the Medical Ethics Committee of the First Hospital of China Medical University. The clinical trial registration number is 2007L04263.

      Findings

      A total of 223 patients were selected for this study, with 112 patients in the treatment group and 111 in the control group. The lung function of the 2 groups after treatment significantly increased in all (P < 0.05); however, there was no significant difference in the changes between the 2 groups (P > 0.05). The occurrence of related adverse events at varying degrees in the control group was higher than in the treatment group.

      Implications

      It is safe and effective to use tratinterol hydrochloride tablets to treat bronchial asthma.

      Key words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Clinical Therapeutics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Cazzola M.
        • Page C.P.
        • Rogliani P.
        • et al.
        β2-agonist therapy in lung disease.
        Am J Respir Crit Care Med. 2013; 187: 690-696
      1. Deng Weiwu, Zhang Liye, et al. Studies on procaterol in 172 bronchial asthma and asthmatic bronchitis patients. New Drugs Clin Rem1993,12:258-259.

        • Lou Weici Liu Bingkun
        • Erzhang Chen
        • et al.
        Clinical observation of procaterol in the treatment of bronchial asthma.
        Clin Medicine China. 1992; 8: 320-321
        • Cui Yimin Zhao Xia
        • Peihong S.u.n.
        • et al.
        Tolerability and pharmacokinetics of tratinterol hydrochloride tablets in healthy subjects after a single dose administration.
        Chin J Clin Pharmacol. 2008; 24: 25-28
        • Zhou Ying Zhao Xia
        • Hongpei S.u.n.
        • et al.
        Tolerability and pharmacokinetics of tratinterol hydrochloride tablets in healthy subjects after multiple dose administration.
        Chin J Clin Pharmacol. 2008; 24: 407-409
        • Gan L.L.
        • Wang M.W.
        • Cheng M.S.
        • Pan L.
        Trachea relaxing effects and beta2-selectivity of SPFF, a newly developed bronchodilating agent, in guinea pigs and rabbits.
        Biol Pharm Bull. 2003; 26: 323-328
        • Hao Z.
        • Zhang Y.
        • Pan L.
        • et al.
        Comparison of enantiomers of SPFF, a novel beta2-Adrenoceptor agonist, in bronchodilating effect in guinea pigs.
        Biol Pharm Bull. 2008; 31: 866-872
        • Li K.
        • Wang Y.
        • Zhang L.
        • et al.
        Simultaneous determination of tratinterol and its metabolites in rat urine and feces by liquid chromatography–tandem mass spectrometry.
        J Chromatogr B. 2013; 934: 89-96
        • Kong L.
        • Yuan Y.
        • Shao Y.
        • et al.
        Efficacy and tolerability of tratinterol hydrochloride tablets in bronchial asthma: a multicenter, randomized, double-blind, dose-finding clinical trial.
        Clin Ther. 2014 Sep 1; 36: 1195-1204
      2. Global Initiative for Asthma. Global strategy for asthma management and prevention. Updated 2006. http://www.ginasthma.org. Accessed September 5, 2014.

        • Bara I.
        • Ozier A.
        • De Lara J.M.T.
        • et al.
        Pathophysiology of bronchial smooth muscle remodelling in asthma.
        Eur Respir J. 2010; 36: 1174-1184
        • Chazan R.
        • Droszcz W.
        • Maruchin J.E.
        Pharmacodynamics of salbutamol in humans.
        Int J Clin Pharmacol Ther Toxicol. 1988; 26: 385-387
        • Slattery D.
        • Wong S.W.
        • Colin A.A.
        Levalbuterol hydrochloride.
        Pediatr Pulmonol. 2002; 33: 151-157
        • Nyberg L.
        • Wong C.
        Advances in terbutaline pharmacokinetics.
        Eur J Respir Dis. 1984; 65: 134
        • Gumbhir-Shah K.
        • Kellerman D.J.
        • DeGraw S.
        • et al.
        Pharmacokinetics and pharmacodynamics of cumulative single doses of inhaled salbutamol enantiomers in asthmatic subjects.
        Pulm Pharmacol Ther. 1999; 12: 353-362
        • Siegel S.C.
        • Katz R.M.
        • Rachelefsky G.S.
        • et al.
        A placebo-controlled trial of procaterol: A new long-acting oral beta 2-agonist in bronchial asthma.
        J Allergy Clin Immunol. 1985; 75: 698-705
        • Kohyama T.
        • Yamauchi Y.
        • Takizawa H.
        • et al.
        Procaterol inhibits lung fibroblast migration.
        Inflammation. 2009; 32: 387-392
        • Huang C.H.
        • Chu Y.T.
        • Kuo C.H.
        • et al.
        Effect of procaterol on Th2‐related chemokines production in human monocyte and bronchial epithelial cells.
        Pediatr Pulmonol. 2010; 45: 977-984
        • Yamaya M.
        • Nishimura H.
        • Hatachi Y.
        • et al.
        Procaterol inhibits rhinovirus infection in primary cultures of human tracheal epithelial cells.
        Eur J Pharmacol. 2011; 650: 431-444
        • Deng Z.
        • Gao Z.C.
        • Ge H.Q.
        • et al.
        Treatment responses of procaterol and CD38 inhibitors in an ozone-induced airway hyperresponsiveness mice model.
        Biol Pharm Bull. 2012; 36: 1348-1355
        • Komatani-Tamiya N.
        • Daikoku E.
        • Takemura Y.
        • et al.
        Procaterol-stimulated Increases in Ciliary Bend Amplitude and Ciliary Beat Frequency in Mouse Bronchioles.
        Cell Physiol Biochem. 2012; 29: 511-522
        • Tashimo H.
        • Yamashita N.
        • Ishida H.
        • et al.
        Effect of procaterol, a beta (2) selective adrenergic receptor agonist, on airway inflammation and hyperresponsiveness.
        Allergol Int. 2007; 56: 241-247