Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health

Denver, Colorado, 80121, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Determining phenotypes non-invasively

Time frame: October, 2015

Comparing invasive phenotyping to non-invasive

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

MedImmune LLC

Registry information

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: May 1, 2012
Registry last updated: Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed