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Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

This study is currently recruiting participants.
Verified April 2012 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: November 26, 2012
Last verified: April 2012
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by National Jewish Health:

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: January 2014
Estimated Primary Completion Date: January 2014 (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
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: November 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by National Jewish Health:
Asthma

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

ClinicalTrials.gov processed this record on May 16, 2013