title: Efficacy of Andolast in Mild to Moderate Asthma: A Randomized, Controlled, Double-Blind Multicenter Study (The Andast Trial).
abstract: BACKGROUND
  Andolast is a new airway specific anti-inflammatory agent. The aim of the present multicentered, randomized, placebo controlled study is to investigate whether andolast produces a therapeutic response greater than placebo in asthmatic adult patients.
  
  
  METHODS
  549 symptomatic patients with mild or moderate asthma were randomized to receive andolast at three different doses (2, 4, or 8 mg t.i.d.) or placebo for 12 weeks. Efficacy and safety were evaluated during scheduled visits with pulmonary function tests, peak expiratory flow rate (PEFR), symptoms diary and quality of life questionnaire. The primary outcome included the changes (expressed as percent variation) from baseline of the forced expiratory volume in one second (FEV1) absolute values after 12 weeks of treatment.
  
  
  RESULTS
  One hundred and thirty one (131) patients were treated with andolast at the dose of 2 mg t.i.d., 128 patients at the dose of 4 mg t.i.d., 144 at the dose of 8 mg t.i.d. and 146 with placebo. Andolast produced a dose dependent significant improvement over placebo on airflow obstruction, as shown by the changes in FEV1 (andolast 2, 4, 8 mg vs. placebo: p = 0.011), especially in a subgroup of patients showing moderate airways obstruction (FEV1<80%pred). The mean number of asthma control days and free days significantly increased, the average number of inhaled puffs of short-acting α2-agonists used as rescue medication was significantly reduced as compared with placebo. Andolast also significantly decreased the incidence of asthma exacerbation episodes.
  
  
  CONCLUSIONS
  Andolast proved to be significantly more effective than placebo in improving airflow, and in controlling asthma symptoms both during day and night.
authors.affiliation: Department of Internal Medicine, University of Brescia, Spedali Civili. Pzza Spedali Civili 1. 25100 Brescia -Italy. malerba@med.unibs.it.
authors.forename: Mario
authors.initials: M
authors.lastname: Malerba
authors.forename: Massimo
authors.initials: M
authors.lastname: D Amato
authors.forename: Alessandro
authors.initials: A
authors.lastname: Radaeli
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Giacovelli
authors.forename: Lucio
authors.initials: L
authors.lastname: Rovati
authors.forename: Sayed H
authors.initials: SH
authors.lastname: Arshad
authors.forename: Stephen T
authors.initials: ST
authors.lastname: Holgate
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001549:Benzamides / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D001549:Benzamides; D013777:Tetrazoles; C442702:andolast