Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Jewish Health
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
National Jewish Health
ClinicalTrials.gov Identifier:
NCT01589198
First received: April 27, 2012
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • Determining phenotypes non-invasively [ Time Frame: October, 2015 ] [ Designated as safety issue: Yes ]
    Comparing invasive phenotyping to non-invasive


Biospecimen Retention:   Samples Without DNA

Blood and lung samples will be retained for RNA purposes.


Estimated Enrollment: 110
Study Start Date: January 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We are looking for mild non-smoking asthmatic adults who are well-controlled with their asthma therapy (non-refractory asthmatics).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589198

Contacts
Contact: Jennifer Brandorff, BA 303-398-1443 brandorffj@njhealth.org
Contact: Juno Pak, BS 303-398-1443 pakj@njhealth.org

Locations
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80121
Contact: Jennifer Brandorff, BA    303-398-1443    brandorffj@njhealth.org   
Contact: Juno Pak, BS    303-398-1443    pakj@njhealth.org   
Principal Investigator: Martin Richard, MD         
Sub-Investigator: Good, Jr James, MD         
Sponsors and Collaborators
National Jewish Health
MedImmune LLC
Investigators
Principal Investigator: Richard Martin, MD National Jewish Health
  More Information

No publications provided

Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT01589198     History of Changes
Other Study ID Numbers: NJH HS-2639
Study First Received: April 27, 2012
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by National Jewish Health:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014