Overview

Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease

Status:
Completed
Trial end date:
2004-01-01
Target enrollment:
0
Participant gender:
All
Summary
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."
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Kaiser Permanente
Treatments:
Ipratropium
Criteria
Inclusion Criteria:

- cough with or without sputum production for less than 30 days duration; were age 18
through 65; and were willing to follow up by phone for a brief interview at 2, 4, and
8 days after enrollment

Exclusion Criteria:

- history of COPD; asthma; or other lung disease; had localized lung findings on exam to
suggest pneumonia or asthma; chest X-ray (if done) with evidence of pneumonia;
purulent nasal discharge or other evidence of bacterial sinus infection; evidence of
streptococcal pharyngitis; temperature greater than 101.5 in the preceding 72 hours;
treatment of a respiratory tract infection in the last 30 days; pregnancy; breast
feeding; actively trying to become pregnant; history of heart failure; history of
renal failure or insufficiency with a creatinine greater than 2.0 mg/dl; history of
psychiatric illness other than minor depression; currently incarcerated; or were
unwilling to sign the consent form.