Study Population

Male and female ambulatory outpatients, aged 29 to 83 years, who had chronic stable bronchitis, as defined by criteria of the American Thoracic Society, entered this eight-week study. All candidates admitted to bringing up mucus on most days, but many also complained of cough with difficult expectoration after waking in the morning, or episodes of repeated coughing and little or no effective expectoration. A physical examination was performed and a medical history was obtained for each patient at the initial visit. To be eligible, each patient had to have a pre-bronchodilator forced expiratory volume (FEV,) of less than 75 percent of the predicted value, as documented by medical history within the past 12 months or at the time of entry into the study. A post-bronchodilator FEV, also was to be documented for each patient in a similar manner. Patients who smoked were asked not to alter their usual consumption for the duration of the study.

Pregnant or nursing women and subjects with a history or evidence of sensitivity to iodide or other halogens, or any iodide- containing compounds, were excluded from the study. Subjects with concomitant illnesses that could either confound an evaluation of response to treatment or affect their ability to comply with the study requirements were not enrolled. The study excluded patients with a diagnosis of asthma and patients who had experienced an acute exacerbation of chronic bronchitis in the four weeks prior to study entry. Brents with a history of drug addiction, alcohol abuse, or noncompliance were excluded from the study. Patients who required antibiotic therapy at entry or those using inhaled anticho­linergic therapy were excluded, unless treatment ceased at least one week prior to entry.
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Glucocorticosteroids and xanthine bronchodilators were permit­ted if a patient was stabilized and on a maintenance dosage prior to entering the study and remained on the maintenance regimen throughout the study. Patients were permitted to use betas agonist therapy. Non-prescription analgesics, short-acting antihistamines or anxiolytics, or dextromethorphan were allowed during the study, as needed. Informed consent was obtained from all patients who entered the study. The Western Institutional Review Board (Olym- pia, WA) reviewed and approved the protocol and the study investigators.

Study Design

Each entering patient received two tablets four-times-daily, in accordance with a computer generated randomization schedule. The assigned regimen was administered to each patient for eight weeks in a double-blind, placebo-controlled, parallel study design. The active treatment group received Organidin tablets, each con­taining 30-mg of iodinated glycerol and the inactive treatment group received identically-appearing placebo tablets, which contained the same excipients as the iodinated glycerol tablets. Patients were instructed to take each 60 mg dose of iodinated glycerol or placebo with at least one-half glass of nonalcoholic beverage at breakfast, lunch, dinner, and at bedtime.

At the start of treatment (visit 1), each patient was given sufficient drug for 35 days of continuous therapy and asked to return at week 4 (visit 2) for a patient and investigator evaluation of treatment. Patients were given sufficient drug for another 35 days of treatment and asked to return at week 8 (visit 3) of the study for a final evaluation of therapy. Compliance was determined during the trial by a count of returned medication at each visit. canadian pharmacy cialis

The primary objective of this study was to assess the safety and efficacy of orally administered iodinated glycerol tablets vs placebo as adjunctive therapy in the management of patients with stable, chronic bronchitis. A second objective of the study was to ascertain whether any subgroups were responsive to therapy based on the assessment of protocol defined primary and secondary efficacy parameters.

Category: Diseases / Tags: lodinated Glycerol, Mucolytic Study, Obstructive Bronchitis, placebo-controlled study

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