Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01589198

Enrollment

110

Registered

2012-05-01

Start date

2012-01-31

Completion date

2016-06-30

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Determining phenotypes non-invasively	October, 2015	Comparing invasive phenotyping to non-invasive

Countries

United States

Outcome results