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.

FINDINGS:

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.

CONCLUSION:

Andolast proved to be significantly more effective than placebo in improving airflow, and in controlling asthma symptoms both during day and night.

• Authors: Mario Malerba, Massimo D Amato, Alessandro Radaeli, Giampaolo Giacovelli, Lucio Rovati, Sayed H Arshad, Stephen T Holgate
• Journal: Current pharmaceutical design (Curr Pharm Des) Vol. 21 Issue 26 Pg. 3835-43 ( 2015) ISSN: 1873-4286 [Electronic] United Arab Emirates
• PMID: 25845448 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Asthmatic Agents
• Benzamides
• Tetrazoles
• andolast

Topics

• Adolescent
• Adult
• Aged
• Anti-Asthmatic Agents (administration & dosage, therapeutic use)
• Asthma (drug therapy)
• Benzamides (administration & dosage, therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Forced Expiratory Volume (drug effects)
• Humans
• Male
• Middle Aged
• Tetrazoles (administration & dosage, therapeutic use)
• Treatment Outcome
• Young Adult