Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

Asthma Clinical Trial

Official title:

Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589198
• Other study ID #: NJH HS-2639
• Status: Completed
• Phase: N/A
• First received: April 27, 2012
• Last updated: March 27, 2017
• Start date: January 2012
• Est. completion date: June 2016

Study information

• Verified date: March 2017
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

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