Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Bronchitis Cough

Drug Information available for: Ipratropium bromide Ipratropium

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

Improvement in cough symptomology

Secondary Outcome Measures:

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371527

Locations

United States, California
South Sacramento Kaiser Permanente
Sacramento, California, United States, 95823

Sponsors and Collaborators

Kaiser Permanente

Investigators

Principal Investigator:	Thomas B McIlraith, MD	Mercy Medical Group
Principal Investigator:	Norman Chow, MD	Kaiser Permanente

More Information

No publications provided

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

Keywords provided by Kaiser Permanente:

Bronchitis
Acute bronchitis
Ipratropium
Cough

Metered dose inhaler
Antibiotic prescriptions
Sputum production

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 08, 2010