Clinical Trial: Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease
Brief 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."
Detailed Summary:
METHODS
COUGH STOP was an investigator-initiated study. We conducted a prospective, randomized, double blind, placebo controlled trial to test the hypothesis that ipratropium would improve cough symptoms in otherwise healthy subjects with acute bronchitis. Subjects were enrolled between October 9th 2002 and November 1 2003, and were included if they had a 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. Subjects were excluded if they had a 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.
The study was reviewed and approved by the IRB for our facility, and approved by the FDA by way of an IND application. Subjects were either referred to one of the study investigators by a practicing physician or nurse practitioner at our facility, or were enrolled by a member of our team directly. Subjects were given a copy of the consent form, asked to review it and ask questions. Those who signed the consent form were randomly assigned to treatment with ipratropium or placebo metered dose inhaler (MDI). The assignment key was maintained by the pharmacy an
Sponsor: Kaiser Permanente
Current Primary Outcome: Improvement in cough symptomology
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
Original Secondary Outcome: Same as current
Information By: Kaiser Permanente
Dates:
Date Received: August 31, 2006
Date Started: October 2002
Date Completion: January 2004
Last Updated: October 16, 2008
Last Verified: August 2006
