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NCT00359073 · ClinicalTrials.gov registry record · NA

Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma

A NA study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
NA
Development phase
25
Enrollment target

NCT00359073: Completed NA study, sponsored by University of Wisconsin, Madison.

NCT00359073 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00359073, a NA study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target

Study Summary

People with asthma may have asthma worsening when they have an upper respiratory infection due to a virus or a common cold. Leukotrienes are increased in nasal secretions from children with Respiratory Syncytial Virus (RSV) and lung washings during times of acute lung inflammation. Experimental virus exposure in adults is also associated with increases in nasal leukotrienes. The degree to which leukotrienes play a role in asthma worsening is unknown.There is information linking leukotrienes to viral infections, allergic inflammation, and asthma exacerbation.This information supports the hypothesis that virus-induced leukotrienes contribute to the severity of respiratory infections and in susceptible individuals, lead to lower airway obstruction and exacerbations of asthma. We propose to use montelukast in an experimental viral challenge model to explore this hypothesis.

Primary Outcome

Asthma symptom scores were assessed twice per day with subjects completing a validated daytime diary card before bed and a nocturnal diary card on awakening. Subjects answered 4 questions about their asthma symptoms (0, none of the time; 6, all of the time). Daily score were calculated as the average of the 4 questions and an overall score for the week was assessed as the average of the daily scores. Time frame measurement was Day 7.

Interventions

  • DRUG placebo
  • DRUG montelukast

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2006-10
Est. Completion 2009-01
Phase NA
University of Wisconsin, Madison

1,039 total trials

What the finished NCT00359073 record still lists

NCT00359073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00359073 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00359073 about?

NCT00359073 is a clinical study titled "Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma". People with asthma may have asthma worsening when they have an upper respiratory infection due to a virus or a common cold. Leukotrienes are increased in nasal secretions from children with Respiratory Syncytial Virus (RSV) and lung washings during times of acute lung inflammation. Experimental viru...

What is the current status of trial NCT00359073?

This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2006-10. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00359073?

The interventions under investigation include: placebo (DRUG), montelukast (DRUG).

Who is sponsoring clinical trial NCT00359073?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00359073's enrollment target sits among peer trials

25 1712th of 2000 higher than 265 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00359073, the US trial registry maintained by the National Library of Medicine. NCT00359073 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.