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

NCT00371527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2008-10-17

No results posted yet for this study

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."

Conditions

  • Bronchitis

Interventions

DRUG

ipratropium

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Thomas B McIlraith, MD · Mercy Medical Group

  • Norman Chow, MD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-10-31
Completion
2004-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00371527 on ClinicalTrials.gov