Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease
NCT00371527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2008-10-17
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."
Conditions
- Bronchitis
Interventions
- DRUG
-
ipratropium
Sponsors & Collaborators
-
Kaiser Permanente
lead OTHER
Principal Investigators
-
Thomas B McIlraith, MD · Mercy Medical Group
-
Norman Chow, MD · Kaiser Permanente
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2002-10-31
- Completion
- 2004-01-31
Countries
- United States
Study Locations
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