Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease
ABSTRACT CONTEXT: Inappropriate antibiotic prescriptions for acute bronchitis is a major public health concern because of antibiotic resistance. Effective therapies for managing the symptoms of acute bronchitis are lacking, however.
OBJECTIVE: Determine if patients with acute bronchitis have better symptom control when treated with inhaled ipratropium.
DESIGN, SETTING, PARTICIPANTS: COUGH STOP was a randomized, double blind, placebo controlled trial comparing ipratropium with placebo in acute bronchitis. Subjects were referred by their primary care provider or from urgent care clinics at a single institution. Subjects had been diagnosed with acute bronchitis and had no significant co-morbidities.
INTERVENTION: Subjects received ipratropium or placebo inhalers, administering 2 puffs four times daily. A structured telephone interview took place 2, 4, and 8 days after enrollment. Medical records were reviewed at 60 days.
OUTCOME: The primary endpoint was improvement in cough symptomology; secondary endpoints included subsequent antibiotic prescriptions and "well being."
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease|
- Improvement in cough symptomology
- Subsequent antibiotic prescriptions
- Frequency of follow up visits for similar complaints in the subsequent two months
- Sense of well being
- Time away from work or usual activities.
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||January 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00371527
|United States, California|
|South Sacramento Kaiser Permanente|
|Sacramento, California, United States, 95823|
|Principal Investigator:||Thomas B McIlraith, MD||Mercy Medical Group|
|Principal Investigator:||Norman Chow, MD||Kaiser Permanente|