Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma

NCT00359073 | Completed Results

• 2 other identifiers: H-2006-017331799
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

asthma; leukotrienes; rhinovirus

Outcome Measures

Primary Outcomes (1)

• Mean Asthma Symptom Score

  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.

  Day 7

Secondary Outcomes (2)

• Peak Viral Shedding

  Baseline and 7 days

• Sputum Eosinophil Count

  14 days

Study Arms (2)

Montelukast

ACTIVE COMPARATOR

montelukast (10 mg everyday)

Drug: montelukast

Placebo

PLACEBO COMPARATOR

Placebo comparator

Drug: placebo

Interventions

montelukast DRUG

10 mg everyday

Also known as: Singulair

Montelukast

placebo DRUG

like placebo

Also known as: like placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female with no health concerns that might affect the outcome of the study
• Age 18-65 range
• diagnosis of mild persistent asthma based on clinical findings such as cough, wheeze and shortness of breath
• a history of asthma for at least six months prior to screening
• FEV1\> 80% of predicted
• presence of allergy based on at least one positive prick skin test when tested with a standard panel of common allergens
• ability to produce sputum when induced during the baseline assessments
• asthma medications consisting of only inhaled short acting B-agonist taken as needed
• reversible airways disease as indicated by \> 12% reversibility post B-agonist or
• methacholine hyperresponsiveness (PC20 \< 8 mg/ml)
• ability to give valid informed consent to participate by signing and dating a written consent form

You may not qualify if:

• History of severe episodes of asthma with respiratory infections
• Screening serum RV16 antibody titer \> 1
• Current smoker or has a smoking history exceeding 5 pack years
• Currently receiving immunotherapy
• Currently participating in another clinical trial or has participated in an investigational drug trial within one month of screening
• Unable, in the judgment of the investigator, to comply with directions and/or tolerate the procedures required for participation in this trial
• Pregnant or breast-feeding or has a planned pregnancy during the course of the study
• Regular use of an asthma controller such as montelukast or an inhaled corticosteroid.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Kloepfer KM, DeMore JP, Vrtis RF, Swenson CA, Gaworski KL, Bork JA, Evans MD, Gern JE. Effects of montelukast on patients with asthma after experimental inoculation with human rhinovirus 16. Ann Allergy Asthma Immunol. 2011 Mar;106(3):252-7. doi: 10.1016/j.anai.2010.11.021. Epub 2011 Jan 13.

  PMID: 21354028 DERIVED

Related Links

• Allergy,Asthma and Pulmonary Clinical Research Unit website

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Was a pilot study; small sample size limited statistical power; subgroup analysis not applicable

Results Point of Contact

• Title: Gina Crisafi
• Organization: University of Wisconsin Madison

gmc@medicine.wisc.edu

608-262-5240

Study Officials

• James E Gern, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: October 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)