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OpenTrials
Completed

NCT Number: NCT00528814

Effectiveness of a School-Based Hand Sanitizer Program on Reducing Asthma Exacerbations

Asthma is a common, serious illness among children in the United States. Improving hand cleanliness and hygiene may prevent the spread of viruses that can cause asthma exacerbations. This study will evaluate the effectiveness of a school-based hand sanitizer program at reducing the frequency of exacerbations in children with asthma.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Lung Health Center

Birmingham, Alabama, 35233, United States

About this study

In the United States, almost 9 million children have been diagnosed with asthma. It is a leading cause of hospitalizations and school absenteeism among children. Asthma symptoms are often seasonal, with the greatest number of exacerbations occurring in autumn and the fewest in mid-summer. Elementary school children are the most vulnerable to these seasonal changes, and many children experience an increase in exacerbations at the beginning of the school year. Recent research suggests that this seasonal peak in exacerbations is primarily caused by viral respiratory tract infections that are spread among children in school. Regular handwashing has been widely recognized as the most effective way to stop the spread of viruses and infectious illnesses. However, effective handwashing methods among school-age children can be inconsistent. Time constraints, a frequent lack of soap and towels, inconveniently located sinks, and water-saving faucets are all barriers to thorough handwashing. Improving hand hygiene through the use of antimicrobial rinse-free hand sanitizers in school classrooms may be a simple and effective way to reduce the risk of transmitting viruses that can cause asthma exacerbations. The purpose of this study is to evaluate the effectiveness of a school-based hand sanitizer program at decreasing exacerbations in children with asthma.

This study will enroll children with asthma who are attending one of the 32 participating schools. Each school will be randomly assigned to either use their usual hand hygiene practices in Year 1, followed by a two-step hand hygiene program including hand washing plus hand sanitizer in Year 2, or vice versa. Each participant will log in to an Internet-based data collection system on a daily basis to document their asthma symptoms and peak flow meter readings. Teachers will also log in daily to verify participants' data and to document participants' absences and the reason for the absence. Quick relief medication use will be recorded and measured through the use of a Doser device on participants' inhalers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with asthma
  • Enrolled in a participating elementary school

Treatment and study plan

Active Hand Sanitizer

Other

Active Hand Sanitizer

Other names: Purell

Primary outcomes

  1. Asthma exacerbations

    Time frame: Measured at Years 1 and 2

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Blue Cross Blue Shield
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Schering-Plough

Registry information

Official study title

Effect of a School Based Hand Sanitizer Program on Asthma

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 12, 2007
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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