The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up: Effectiveness of early intervention with budesonide in mild persistent asthma

• Published in: Journal of allergy and clinical immunology Vol. 121; no. 5; pp. 1167 - 1174
• Main Authors: Busse, William W., MD, Pedersen, Søren, MD, Pauwels, Romain A., MD, Tan, Wan C., MD, Chen, Yu-Zhi, MD, Lamm, Carl Johan, PhD, O'Byrne, Paul M., MD
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.05.2008; Elsevier; Elsevier Limited
• Subjects: Administration, Inhalation; Adolescent; Adult; Aged; Airway management; Allergy and Immunology; Asthma; Asthma - drug therapy; Biological and medical sciences; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Budesonide - administration & dosage; Budesonide - adverse effects; budesonide dry-powder inhaler; Child; Child, Preschool; Double-Blind Method; Drug therapy; Female; Follow-Up Studies; Forced Expiratory Volume - drug effects; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Health facilities; Humans; Immunopathology; inhaled corticosteroid; Male; Medical sciences; Middle Aged; Mild persistent asthma; Mortality; Placebos; recent-onset asthma; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Treatment Outcome; Prevention of Early Asthma in Kids; OR; Severe asthma-related event; Childhood Asthma Management Program; SARE; recent-onset asthma; inhaled corticosteroid; Inhaled Steroid Treatment As Regular Therapy in Early Asthma; budesonide dry-powder inhaler; ICS; Odds ratio; PEAK; START; Mild persistent asthma; CAMP; Steroid; Lung disease; Budesonide; Corticosteroid; Immunopathology; Respiratory disease; Powder; Asthma; Inhalation; Immunology; Treatment; Age of onset; Efficiency; Follow up study; Inhaler; Bronchus disease; Early; Obstructive pulmonary disease
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/j.jaci.2008.02.029

Background The Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study enrolled 7241 patients aged 5 to 66 years with recent-onset, mild persistent asthma to assess early intervention with the inhaled corticosteroid budesonide on long-term asthma control. Objective The open-label phase of the START study was included to determine the effect on lung function and asthma control of adding budesonide to the reference group patients who had not initially received inhaled corticosteroids. Methods Patients were randomized to double-blind treatment with budesonide, 200 μg (those aged <11 years) or 400 μg once daily, or placebo plus the usual asthma therapy for 3 years, after which all patients received 2 years of open-label treatment with budesonide once daily. Results During the full 5-year study period, postbronchodilator FEV1 percent predicted decreased, irrespective of randomized treatment during the double-blind phase, by an average of 2.22% (SE, 0.15%). However, patients with inhaled budesonide in the double-blind phase had a significantly lower risk (odds ratio, 0.61; P < .001) of a severe asthma-related event during the full 5-year study period than those in the reference group. Moreover, patients in the reference group used more additional asthma medications during both the open-label and double-blind phases. Conclusions In mild persistent asthma early intervention with inhaled budesonide was associated with improved asthma control and less additional asthma medication use.