title: Efficacy and tolerability of tratinterol hydrochloride tablets in bronchial asthma: a multicenter, randomized, double-blind, dose-finding clinical trial.
abstract: OBJECTIVE
  The aims of this study were to determine the efficacy and tolerability of different dosages of, and to identify the best dosage of, tratinterol hydrochloride tablets in the treatment of bronchial asthma.
  
  
  METHODS
  This multicenter, randomized, double-blind, dose-finding clinical research study was completed at 3 centers in the People's Republic of China from March 2008 to February 2009. Each center selected patients with bronchial asthma whose forced expiratory volume in 1 second (FEV1) values were <80% of predicted normal (pretreatment). Patients were assigned to 1 of 3 groups, based on daily dosage: low, 50 μg/d; intermediate, 100 μg/d; and high, 150 μg/d. Doses were administered orally twice daily for 10 days. The primary end points were the changes from baseline (0 minutes) in peak expiratory flow (PEF) and FEV1 at 30 minutes and 1, 2, 4, 6, and 12 hours after administration. Secondary end points were changes from baseline in forced vital capacity and asthma scores. Tolerability was monitored throughout the study period using physical examinations, laboratory testing, and spontaneous reporting.
  
  
  RESULTS
  A total of 72 patients were selected in this study (24 per group; 40 men; 32 women; mean age, 43.48 years). The efficacy analysis (per-protocol set) included 20, 20, and 22 patients in the low-, intermediate-, and high-dosage groups, respectively. In terms of the primary and secondary end points, the intermediate dosage was most efficacious, followed by the high and low dosages, respectively. All 3 dosages were well-tolerated.
  
  
  CONCLUSIONS
  In these patients with bronchial asthma, 100 μg/d was the dosage of tratinterol hydrochloride tablets most efficacious in terms of improvement in lung function. All 3 dosages were well-tolerated.
authors.affiliation: The First Hospital, China Medical University, Shenyang, People's Republic of China.
authors.forename: Lingfei
authors.initials: L
authors.lastname: Kong
authors.affiliation: The First Hospital, China Medical University, Shenyang, People's Republic of China.
authors.forename: Yuan
authors.initials: Y
authors.lastname: Yuan
authors.affiliation: The Second Hospital, Harbin Medical University, Harbin, People's Republic of China.
authors.forename: Yuxia
authors.initials: Y
authors.lastname: Shao
authors.affiliation: The Third Xiangya Hospital, Xiangya, People's Republic of China.
authors.forename: Shenghua
authors.initials: S
authors.lastname: Sun
authors.affiliation: The First Hospital, China Medical University, Shenyang, People's Republic of China.
authors.forename: Jiaming
authors.initials: J
authors.lastname: Liu
authors.affiliation: The First Hospital, China Medical University, Shenyang, People's Republic of China. Electronic address: kangjian58@163.com.
authors.forename: Jian
authors.initials: J
authors.lastname: Kang
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000814:Aniline Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002681:China; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate; D010626:Phenylethyl Alcohol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D012720:Severity of Illness Index; D013607:Tablets; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D000814:Aniline Compounds; D001993:Bronchodilator Agents; D013607:Tablets; C000606156:tratinterol; D010626:Phenylethyl Alcohol
keywords: asthma; randomized multicenter clinical study; tratinterol hydrochloride; β(2)-adrenergic receptor agonist