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.
Keywords: Asthma treatment, potassium channel opener, randomized controlled trial.
Current Pharmaceutical Design
Title:Efficacy of Andolast in Mild to Moderate Asthma: A Randomized, Controlled, Double-Blind Multicenter Study (The Andast Trial)
Volume: 21 Issue: 26
Author(s): Mario Malerba, Massimo D`Amato, Alessandro Radaeli, Giampaolo Giacovelli, Lucio Rovati, Sayed H. Arshad and Stephen T. Holgate
Affiliation:
Keywords: Asthma treatment, potassium channel opener, randomized controlled 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.
Export Options
About this article
Cite this article as:
Malerba Mario, D`Amato Massimo, Radaeli Alessandro, Giacovelli Giampaolo, Rovati Lucio, Arshad H. Sayed and Holgate T. Stephen, Efficacy of Andolast in Mild to Moderate Asthma: A Randomized, Controlled, Double-Blind Multicenter Study (The Andast Trial), Current Pharmaceutical Design 2015; 21 (26) . https://dx.doi.org/10.2174/1381612821666150407101614
DOI https://dx.doi.org/10.2174/1381612821666150407101614 |
Print ISSN 1381-6128 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4286 |
Call for Papers in Thematic Issues
"Tuberculosis Prevention, Diagnosis and Drug Discovery"
The Nobel Prize-winning discoveries of Mycobacterium tuberculosis and streptomycin have enabled an appropriate diagnosis and an effective treatment of tuberculosis (TB). Since then, many newer diagnosis methods and drugs have been saving millions of lives. Despite advances in the past, TB is still a leading cause of infectious disease mortality ...read more
Current Pharmaceutical challenges in the treatment and diagnosis of neurological dysfunctions
Neurological dysfunctions (MND, ALS, MS, PD, AD, HD, ALS, Autism, OCD etc..) present significant challenges in both diagnosis and treatment, often necessitating innovative approaches and therapeutic interventions. This thematic issue aims to explore the current pharmaceutical landscape surrounding neurological disorders, shedding light on the challenges faced by researchers, clinicians, and ...read more
Emerging and re-emerging diseases
Faced with a possible endemic situation of COVID-19, the world has experienced two important phenomena, the emergence of new infectious diseases and/or the resurgence of previously eradicated infectious diseases. Furthermore, the geographic distribution of such diseases has also undergone changes. This context, in turn, may have a strong relationship with ...read more
Melanoma and Non-Melanoma Skin Cancer Treatment: Standard of Care and Recent Advances
In this thematic issue, we aim to provide a standard of care of the diagnosis and treatment of melanoma and non-melanoma skin cancer. The editor will invite authors from different countries who will write review articles of melanoma and non-melanoma skin cancers. The Diagnosis, Staging, Surgical Treatment, Non-Surgical Treatment all ...read more
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
The Complex Airway in Childhood Asthma
Current Pediatric Reviews A Missed Proteome in Living Organisms: A Hyppo System
Current Proteomics Triterpene Derivatives as Inhibitors of Protein Involved in the Inflammatory Process: Molecules Interfering with Phospholipase A2, Cycloxygenase, and Lipoxygenase
Current Drug Targets Use of Alternative Animals as Asthma Models
Current Drug Targets Recent Patents on the Treatment of Type 1 Diabetes
Recent Patents on Endocrine, Metabolic & Immune Drug Discovery Histamine as a Potential Adjuvant to Immuno and Radiotherapy for Cancer Treatment: Discovering New Functions for the Oldest Biogenic Amine
Current Immunology Reviews (Discontinued) Fermented Foods: Patented Approaches and Formulations for Nutritional Supplementation and Health Promotion
Recent Patents on Food, Nutrition & Agriculture Antisense Strategies
Current Molecular Medicine Clinical Potential of VIP by Modified Pharmaco-kinetics and Delivery Mechanisms
Endocrine, Metabolic & Immune Disorders - Drug Targets Cysteinyl Leukotriene Receptor Antagonists and Thromboxane Synthase Inhibitors: New Targets to Treat Asthma
Current Medicinal Chemistry - Anti-Inflammatory & Anti-Allergy Agents The Cancer Hygiene Hypothesis: From Theory to Therapeutic Helminths
Current Cancer Therapy Reviews Inhalation Cough Challenge
Current Respiratory Medicine Reviews Skin Tests in the Diagnosis of Drug Hypersensitivity Reactions
Current Pharmaceutical Design Genetic Susceptibility to Autoimmune Disorders: Clues from Gene Association and Gene Expression Studies
Current Molecular Medicine Recent Applications of Triazolopyrimidine-Based Bioactive Compounds in Medicinal and Agrochemical Chemistry
Mini-Reviews in Medicinal Chemistry Evaluating Safety of Long-Acting Beta Agonists (LABAs) in Patients with Asthma
Current Drug Safety Non-peptide Antagonists and Agonists of the Bradykinin B2 Receptor
Current Medicinal Chemistry Rhinovirus-Associated Wheeze During Infancy and Asthma Development
Current Respiratory Medicine Reviews Developmental Immunotoxicity (DIT) in Drug Safety Testing: Matching DIT Testing to Adverse Outcomes and Childhood Disease Risk
Current Drug Safety Novel Carriers for Coenzyme Q10 Delivery
Current Drug Delivery