Chest
Clinical Investigations: COPD/REHABIodinated Glycerol Has No Effect on Pulmonary Function, Symptom Score, or Sputum Properties in Patients With Stable Chronic Bronchitis
Section snippets
Study Design
In the previous study6 a significant improvement in well being was demonstrated with IG therapy after 16 weeks. This double-blind, randomized, placebo-controlled, cross-over study is designed to show similar changes after 16 weeks of placebo and IG (30 mg tabs) 60 mg four times daily. The cross-over design has patients serve as their own controls, strengthening the power of the study to detect changes in pulmonary function or sputum properties as a result of therapy.
Patient Selection
Thirty subjects with chronic
RESULTS
Thirty patients were randomized so that half began with the placebo treatment and half with iodinated glycerol therapy. Therapy was crossed over midway through the study. Twenty eight patients completed the iodinated glycerol arm and 26 finished both study arms with complete pulmonary functions recorded and five interval sputum specimens collected. Those who dropped out of the study did so for failure to keep follow up appointments. There were no clinically significant adverse events noted in
DISCUSSION
To our knowledge, this is the first randomized, blinded cross-over trial of a mucoactive agent that simultaneously measured the physical and transport properties of expectorated sputum, pulmonary functions, and well being in patients with chronic bronchitis. In a study of patients with chronic bronchitis taking S-carboxymethylcysteine, an agent thought to reduce sputum viscosity by severing disulfide bonds, Braga and colleagues12 found a reduction in sputum viscosity when patients were on the
ACKNOWLEDGMENT
The authors would like to thank Ms. Titik Dian and John Heller, EE, for help in conducting these studies. We would also like to thank Dr. Jill A. Ohar and Ms. Patricia Dettenmeier, RN, MSN, for providing the sputum specimens from the St. Louis University Pulmonary Clinic.
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Supported by a grant from Wallace Laboratories, Princeton, New Jersey.
revision accepted September 27.