Can Guideline-defined Asthma Control Be Achieved?: The Gaining Optimal Asthma ControL Study

• Published in: American journal of respiratory and critical care medicine Vol. 170; no. 8; pp. 836 - 844
• Main Authors: Bateman, Eric D, Boushey, Homer A, Bousquet, Jean, Busse, William W, Clark, Tim J. H, Pauwels, Romain A, Pedersen, Soren E, GOAL Investigators Group
• Format: Journal Article
• Language: English
• Published: New York, NY Am Thoracic Soc 15-10-2004; American Lung Association; American Thoracic Society
• Subjects: Adrenal Cortex Hormones - administration & dosage; Adrenal Cortex Hormones - therapeutic use; Adult; Albuterol - administration & dosage; Albuterol - adverse effects; Albuterol - analogs & derivatives; Albuterol - therapeutic use; Androstadienes - administration & dosage; Androstadienes - adverse effects; Androstadienes - therapeutic use; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Anti-Asthmatic Agents - administration & dosage; Anti-Asthmatic Agents - adverse effects; Anti-Asthmatic Agents - therapeutic use; Asthma - drug therapy; Asthma - prevention & control; Biological and medical sciences; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Bronchodilator Agents - therapeutic use; Chronic obstructive pulmonary disease, asthma; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Emergency and intensive cardiocirculatory care. Cardiogenic shock. Coronary intensive care; Female; Fluticasone; Forced Expiratory Volume - drug effects; Humans; Intensive care medicine; Male; Medical sciences; Pneumology; Practice Guidelines as Topic; Prospective Studies; Quality of Life; Salmeterol Xinafoate; Surveys and Questionnaires; Time Factors; Treatment Outcome; Corticosteroid; Lung disease; Agonist; Intensive care; antiasthmatic agents; Respiratory disease; Bronchodilator; Antiinflammatory agent; Salmeterol; β2-Adrenergic receptor; β-Adrenergic receptor agonist; Fluticasone; Antiasthma agent; Asthma; Quality of life; fluticasone propionate; Bronchus disease; guidelines; Obstructive pulmonary disease; Resuscitation
• ISSN: 1073-449X; 1535-4970
• DOI: 10.1164/rccm.200401-033OC

For most patients, asthma is not controlled as defined by guidelines; whether this is achievable has not been prospectively studied. A 1-year, randomized, stratified, double-blind, parallel-group study of 3,421 patients with uncontrolled asthma compared fluticasone propionate and salmeterol/fluticasone in achieving two rigorous, composite, guideline-based measures of control: totally and well-controlled asthma. Treatment was stepped-up until total control was achieved (or maximum 500 microg corticosteroid twice a day). Significantly more patients in each stratum (previously corticosteroid-free, low- and moderate-dose corticosteroid users) achieved control with salmeterol/fluticasone than fluticasone. Total control was achieved across all strata: 520 (31%) versus 326 (19%) patients after dose escalation (p < 0.001) and 690 (41%) versus 468 (28%) at 1 year for salmeterol/fluticasone and fluticasone, respectively. Asthma became well controlled in 1,071 (63%) versus 846 (50%) after dose escalation (p < 0.001) and 1,204 (71%) versus 988 (59%) at 1 year. Control was achieved more rapidly and at a lower corticosteroid dose with salmeterol/fluticasone versus fluticasone. Across all strata, 68% and 76% of the patients receiving salmeterol/fluticasone and fluticasone, respectively, were on the highest dose at the end of treatment. Exacerbation rates (0.07-0.27 per patient per year) and improvement in health status were significantly better with salmeterol/fluticasone. This study confirms that the goal of guideline-derived asthma control was achieved in a majority of the patients.