Chronic obstructive bronchitis within the spectrum of chronic obstructive pulmonary disease (COPD) occurs as a result of a complex interplay of inflammatory and morphologic changes in the airways and an associated loss of ciliary function. Obstruction of the peripheral airways appears to be a major cause of airflow limitation. Mucus gland hypertrophy and hyperplasia, and goblet cell metaplasia, are strong morphologic correlates of chronic obstructive bronchitis. While the exact mechanisms of obstruction are not well understood and most likely multifactorial, the importance of mucus is underscored by studies suggesting that goblet cell metaplasia in bronchioles contribute to airflow obstruction. Further, increasing amounts of sputum production are associated with increasing airflow limitation.
Smoking cessation, bronchodilators, glucocorticos- teroids and antibiotics provide a potent armamentarium for the treatment of the symptomatic and airflow abnormalities of COPD in all stages of disease. Treatment is most successful when instituted early, before irreversible changes in airways and alveoli occur. The mucus component of airflow obstruction offers still another treatment strategy. Although it is often neglected in the management of patients, the fact that sputum is a reversible component of COPD should not be overlooked. Mucolytic-expectorant therapy has been largely overlooked because of the difficulty associated with demonstrating effectiveness by objective criteria, the lack of definitive clinical data, and uncertainty about the type of patients who are likely to benefit from this therapeutic modality. If mucus can be effectively cleared, both symptoms and airflow may be improved. Preliminary studies are consistent in demonstrating an improvement in the clinical status of patients with COPD following therapeutic intervention with iodinated glycerol.
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In a double-blind, placebo-controlled study, Pavia et al showed a significant correlation (r = 0.82; p<0.01) between the amount of sputum expectorated and improvement of tracheobronchial clearance after the administration of iodinated glycerol in chronic bronchitis patients; this same group of patients also exhibited a decrease in cough frequency following one week of therapy. Similarly, Repsher et al showed both clinically and statistically a significant reduction in cough frequency and severity and a significant improvement in both the ease of raising sputum and pulmonary status among asthmatic patients after the administration of iodinated glycerol. Prenner also showed definite clinical improvement in patients with asthma or chronic bronchitis following the administration of iodinated glycerol in an uncontrolled open study; 89 percent of patients in this study reported improvement and relief of clinical symptoms.
Therefore, in an attempt to define the role and to clarify the efficacy of mucoactive therapy in chronic obstructive airways disease, the Steering Committee for this study recognized the importance of symptomatology. Patients often insist that mucoevacuants make them feel better, despite a lack of significant changes in pulmonary function tests or sputum characteristics. The primary efficacy parameters for this study were selected on this basis. In the absence of specific objective noninvasive endpoints, the appropriate method for measuring mucus clearance would be the cardinal symptoms of excess mucus.
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The following large multicenter, randomized, double-blind, placebo-controlled, parallel clinical trial was conducted nationwide in the offices of sub- specialists (pulmonologists/allergist) to compare the efficacy and safety of iodinated glycerol versus placebo, given as adjunctive therapy in patients with chronic obstructive bronchitis and moderately severe airflow obstruction.