Status:
COMPLETED
Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
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 Respirator...
Detailed Description
Viral infections are important causes of wheezing illnesses throughout childhood and in adults with asthma. There has been progress in identifying mechanisms and risk factors for severe respiratory sy...
Eligibility Criteria
Inclusion
- A subject with mild persistent asthma is eligible for participation in the study if all of the following inclusion criteria apply:
- 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
Exclusion
- A subject is not eligible to participate in this study if any of the following exclusion criteria apply:
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00359073
Start Date
October 1 2006
End Date
January 1 2009
Last Update
March 13 2018
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792