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Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

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ClinicalTrials.gov Identifier: NCT01589198
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease
Asthma

Study Design

Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma
Study Start Date : January 2012
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Determining phenotypes non-invasively [ Time Frame: October, 2015 ]
    Comparing invasive phenotyping to non-invasive


Biospecimen Retention:   Samples Without DNA
Blood and lung samples will be retained for RNA purposes.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589198


Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80121
Sponsors and Collaborators
National Jewish Health
MedImmune LLC
Investigators
Principal Investigator: Richard Martin, MD National Jewish Health
More Information

Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT01589198     History of Changes
Other Study ID Numbers: NJH HS-2639
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

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