Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

NCT ID: NCT01589198

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role collaborator

National Jewish Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Martin, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

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National Jewish Health

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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NJH HS-2639

Identifier Type: -

Identifier Source: org_study_id

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