Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease
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|ClinicalTrials.gov Identifier: NCT00371527|
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : October 17, 2008
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."
|Condition or disease||Intervention/treatment||Phase|
|Bronchitis||Drug: ipratropium||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease|
|Study Start Date :||October 2002|
|Study Completion Date :||January 2004|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|