History of Changes for Study: NCT01589198
Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma
Latest version (submitted March 27, 2017) on
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Study Record Versions
Version A B Submitted Date Changes
1 April 30, 2012 None (earliest Version on record)
2 November 26, 2012 Study Status
3 January 28, 2014 Study Status
4 September 24, 2014 Study Status and Outcome Measures
5 April 14, 2015 Study Status
6 March 23, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 March 27, 2017 Recruitment Status and Study Status
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Study NCT01589198
Submitted Date:  April 30, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: NJH HS-2639
Brief Title: Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma
Official Title: Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2012
Overall Status: Recruiting
Study Start: January 2012
Primary Completion: January 2014 [Anticipated]
Study Completion: January 2014 [Anticipated]
First Submitted: April 27, 2012
First Submitted that
Met QC Criteria:
April 30, 2012
First Posted: May 1, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 30, 2012
Last Update Posted: May 1, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Jewish Health
Responsible Party: Sponsor
Collaborators: MedImmune LLC
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Asthma
Keywords: Asthma
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Prospective
Biospecimen Retention: Samples Without DNA
Biospecimen Description: Blood and lung samples will be retained for RNA purposes.
Enrollment: 110 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Open or close this module Eligibility
Study Population: We are looking for mild non-smoking asthmatic adults who are well-controlled with their asthma therapy (non-refractory asthmatics).
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts 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
Open or close this module Contacts/Locations
Central Contact Person: Jennifer Brandorff, BA
Telephone: 303-398-1443
Central Contact Backup: Juno Pak, BS
Telephone: 303-398-1443
Study Officials: Richard Martin, MD
Principal Investigator
National Jewish Health
Locations: United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80121
Contact:Contact: Jennifer Brandorff, BA 303-398-1443
Contact:Contact: Juno Pak, BS 303-398-1443
Contact:Principal Investigator: Martin Richard, MD
Contact:Sub-Investigator: Good, Jr James, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Available IPD/Information:

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