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| Sponsor: | Kaiser Permanente |
|---|---|
| Information provided by: | Kaiser Permanente |
| ClinicalTrials.gov Identifier: | NCT00371527 |
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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease |
| 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:
Exclusion Criteria:
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
| Study ID Numbers: | CN 01TMcIl 01 B, CN 01TMcIl 01 B |
| Study First Received: | August 31, 2006 |
| Last Updated: | October 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00371527 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Bronchitis Acute bronchitis Ipratropium Cough |
Metered dose inhaler Antibiotic prescriptions Sputum production |
|
Acute Disease Respiratory System Agents Neurotransmitter Agents Disease Attributes Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Bronchial Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Cholinergic Agents Pharmacologic Actions |
Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Respiratory Tract Infections Ipratropium Autonomic Agents Therapeutic Uses Lung Diseases Bronchitis Peripheral Nervous System Agents Bronchodilator Agents |