Overview

This trial is active, not recruiting.

Condition asthma
Sponsor National Jewish Health
Collaborator MedImmune LLC
Start date January 2012
End date June 2016
Trial size 110 participants
Trial identifier NCT01589198, NJH HS-2639

Summary

The purpose of this study is to learn more about asthma in people who are not well-controlled with current asthma medication (refractory asthma). The investigators will compare data from refractory asthmatic patients here at National Jewish Health to mild asthmatics subjects and to people without asthma. Study experiments involve looking at samples from all 3 groups and comparing them at a molecular level. These laboratory experiments may help identify subtypes of refractory asthmatics that require different treatments.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
Determining phenotypes non-invasively
time frame: October, 2015

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Able to receive Informed Consent - At least 18 years of age - ICS < 880 mcg (FP equivalents) - PC20<=16 mg/mL - No more than 1 oral steroid bursts in previous 12 months - Less that 3 urgent care visit in previous 12 months - No deterioration with <=25% decrease in steroids - No near fatal asthma event Exclusion Criteria: - Pregnancy - Current smoker, smoking within the past year or pack/year history >10 years - Respiratory infection within past 6 weeks - Antibiotics within the past 6 weeks - Active lung disease other than asthma - Cancer within past 5 years (excluding basal cell skin cancer) - Active or chronic infection - Hematological or autoimmune disease - Unable to safely undergo bronchoscopy as determined by doctor or study doctor

Additional Information

Official title Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma
Principal investigator Richard Martin, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by National Jewish Health.