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Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371527
First Posted: September 4, 2006
Last Update Posted: October 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kaiser Permanente
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00371527     History of Changes
Other Study ID Numbers: CN 01TMcIl 01 B
First Submitted: August 31, 2006
First Posted: September 4, 2006
Last Update Posted: October 17, 2008
Last Verified: August 2006

Keywords provided by Kaiser Permanente:
Bronchitis
Acute bronchitis
Ipratropium
Cough
Metered dose inhaler
Antibiotic prescriptions
Sputum production

Additional relevant MeSH terms:
Lung Diseases
Bronchitis
Acute Disease
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Ipratropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action