Evaluating the Asthmatic Response to an Experimental Infection With Rhinovirus in the Atopic

NCT02111772 | Completed Results

• 2 other identifiers: 12673R01AI020565
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with asthma, reactions to allergens in the environment (such as mold, pollen, weed, domestic pets, and dust allergens) play an important role in causing asthma symptoms. However, upper respiratory tract infections, typically those caused by the common cold virus, rhinovirus, can also cause asthma to get worse. In previous studies at the University of Virginia, it was found that mild asthmatics, who had high levels of the allergy antibody (called IgE) in their blood, developed more persistent cold and chest symptoms when they were given an infection with rhinovirus (the most frequent cause of the common cold). The cold symptoms produced by rhinovirus tend to peak during the first 4 -7 days of the cold. These symptoms, including nasal congestion, are similar to what you have experienced with previous colds. This study is being done to learn how a common cold caused by a viral infection affects people with asthma. The goal is to learn how to improve the care of asthma symptoms caused by the common cold virus (called rhinovirus). Most adults experience one or two colds caused by rhinovirus every year. In addition, 75-80% of asthma exacerbations caused by viral infections are caused by this virus, primarily in children. Adults are less likely to experience significant changes in their asthma symptoms when they get colds, because they have developed protective immune responses from previous colds which help diminish symptoms.

Conditions

Asthma

Keywords

mild asthma, rhinovirus, young adults

Outcome Measures

Primary Outcomes (1)

• Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection

  The primary endpoint will be based on the comparison of cumulative lower respiratory tract symptom scores (CLRTS) in the asthmatic subjects compared to the non-asthmatic subjects over the first 4 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, shortness of breath, and cough. Symptom scores, including wheeze, shortness of breath, and chest discomfort were recorded by subjects twice daily. Each symptom was scored on a scale of 1-3. Therefore, the total maximum (worst) score for a day would be 24. The scores recorded daily could range from 0 to 24.

  4 days

Secondary Outcomes (1)

• Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection Evaluated Without Cough.

  4 days

Study Arms (2)

Asthmatic subjects

EXPERIMENTAL

Subjects with Asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus.

Biological: Rhinovirus

Without Asthma

ACTIVE COMPARATOR

Subjects without asthma whose cold and chest symptoms will be evaluated one week before and 4 weeks after an inoculation with rhinovirus

Biological: Rhinovirus

Interventions

Rhinovirus BIOLOGICAL

Asthmatic subjects; Without Asthma

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be able to understand and provide written informed consent
• Age 18 to \< 40 years of age, any gender, any racial/ethnic origin.
• Participant must be willing to comply with study procedures and requirements. Participant must be considered eligible for participation based on results of screening procedures conducted by protocol number 20100686 at VCU and IRB# 12656 at UVA.
• Subjects with asthma
• with physician-diagnosed, mild asthma who are only using bronchodilators (e.g. albuterol) for symptom control.
• Asthma Control Test (ACT) Questionnaire Score a \> 19 at enrollment (See Appendix: Asthma Control Test).
• Short-acting beta-agonist use \< daily in last 4 weeks
• FEV1 \> 70%, or FEV1/FVC ratio \> 75% for subjects with FVC values between 80 and 87% predicted whose FEV1 values fall below 70%. a positive methacholine challenge test (i.e. at least a 20% fall in FEV1) at a methacholine concentration of 16 mg/ml or less (15). The methacholine test will not be done if subjects have used albuterol within 4 hours of the test procedure.Evidence for atopy demonstrated during screening (under IRB protocol# 12656) as judged by positive prick skin tests to one or more aero-allergens.

You may not qualify if:

• Inability or unwillingness of a participant or subject's legal representative to give written informed consent and HIPPA authorization
• Positive test for serum neutralizing antibody to RV-16. Subjects with a neutralizing antibody titer \> 1:4 will be excluded.
• Chronic heart disease, lung diseases other than asthma, or other chronic illnesses, including primary and/or secondary immunodeficiency.
• An upper or lower respiratory tract infection within six weeks prior to enrollment
• Who have required nasal or sinus surgery, excluding surgery for a deviated septum within 12 months prior to enrollment.
• Who have a 5 pack/year history of smoking, or any smoking within the last 6 months.
• Female subjects who are or who plan to become pregnant during the study, or who are nursing a baby. Additionally, to be included in this study, a woman of child-bearing potential must have a negative urine pregnancy test at screening, during the run-in, and prior to viral inoculation and agree to use an effective method of birth control such as, but not limited to, birth control pills, contraceptive foam, diaphragm, IUD, abstinence, or condoms.
• Absolute neutrophil count (ANC) \< 1800 cells/mm3 (or 1.8 K/uL) detected during screening within 6 weeks of enrollment.
• Subjects with asthma
• Who have required inhaled steroids (used for asthma), nasal steroids (used for allergic rhinitis), cromolyn, nedocromil sodium, ipratropium bromide, or leukotriene modifiers during the month prior to enrollment, oral steroids within 6 weeks of enrollment, omalizumab (Xolair®) within 12 months prior to enrollment, or who are currently using beta adrenergic blocking agents.
• Who have been hospitalized or treated in the emergency room (unless the treatment involved the use of a bronchodilator only) for asthma within the last three years.
• To avoid RV-16 inoculations in subjects with more restrictive lung volumes, those whose FVC is \< 80% predicted will be excluded. Subjects who are currently receiving allergen immunotherapy (IT), or who have received allergen IT within the last 3 years.
• Subjects who have had one or more night time awakenings caused by asthma symptoms and/or who have needed their SABA (albuterol) inhaler for asthma symptoms \> 4 days during the week before enrollment, or during the week before the inoculation with RV-16.
• Control subjects
• Who have a positive methacholine test, or positive prick skin tests at screening under IRB protocol # 12656.

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Peter W. Heymann
• Organization: University of Virginia

pwh5a@virginia.edu

434-242-8209

Study Officials

• Heymann W Peter, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Pediatric Allergy and Immunology

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 11, 2014
• Study Start: September 1, 2013
• Primary Completion: April 20, 2017
• Study Completion: April 27, 2017
• Last Updated: July 9, 2018
• Results First Posted: May 29, 2018

Record last verified: 2018-07

Locations

US (1)