Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease
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Purpose
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 | Intervention |
|---|---|
|
Bronchitis |
Drug: ipratropium |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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.
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | January 2004 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00371527 History of Changes |
| Other Study ID Numbers: | CN 01TMcIl 01 B, CN 01TMcIl 01 B |
| Study First Received: | August 31, 2006 |
| Last Updated: | October 16, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kaiser Permanente:
|
Bronchitis Acute bronchitis Ipratropium Cough |
Metered dose inhaler Antibiotic prescriptions Sputum production |
Additional relevant MeSH terms:
|
Bronchitis Acute Disease Lung Diseases Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Respiratory Tract Infections Disease Attributes Pathologic Processes Ipratropium Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013