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Effects of Allergen Inhalation on Adenosine Receptor Expression in Sputum and Peripheral Blood

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00116311
Recruitment Status : Unknown
Verified March 2007 by Groningen Research Institute for Asthma and COPD.
Recruitment status was:  Active, not recruiting
First Posted : June 29, 2005
Last Update Posted : March 21, 2007
Sponsor:
Information provided by:
Groningen Research Institute for Asthma and COPD

Tracking Information
First Submitted Date June 28, 2005
First Posted Date June 29, 2005
Last Update Posted Date March 21, 2007
Study Start Date July 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Allergen Inhalation on Adenosine Receptor Expression in Sputum and Peripheral Blood
Official Title Effects of Allergen Inhalation on Adenosine Receptor Expression and Mast Cell Activation in Peripheral Blood and Sputum of Asthmatics and Healthy Subjects
Brief Summary

The purpose of this study is to determine whether asthmatics have different adenosine receptor expression profiles than healthy controls. We hypothesize that asthmatics will have increased adenosine receptor expression versus control subjects.

We also want to study the effects of allergen inhalation on adenosine receptor expression in asthmatics. We believe that adenosine receptor expression will be upregulated after allergen inhalation.

Both hypotheses are being tested in sputum and peripheral blood.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Asthma
  • Healthy
Intervention
  • Behavioral: allergen inhalation
  • Behavioral: withdrawal of medication
  • Procedure: sputum induction
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: June¬†28,¬†2005)
20
Original Enrollment Same as current
Study Completion Date February 2007
Primary Completion Date Not Provided
Eligibility Criteria

Asthmatic Subjects - Inclusion Criteria:

  • Clinical diagnosis of asthma
  • Steroid naive or subjects not using their inhaled steroids for the last 4 weeks, short-acting beta-agonist for rescue medication
  • FEV1 > 70% of predicted
  • Positive skin prick test for house dust mite, cat or grass pollen
  • PC20 methacholine or histamine < 8 mg/ml

Asthmatic Subjects - Exclusion Criteria:

  • Use of systemic steroids in the previous 6 weeks
  • Asthma exacerbations in the previous 6 weeks
  • Current or ex-smokers with ≥ 10 pack-years (≥ 2 pipe pack-years), ex smokers who stopped less than 1 year ago

Healthy Subjects - Inclusion Criteria:

  • No airway complaints
  • FEV1 > 90% of predicted
  • Negative skin prick test
  • PC20 methacholine or histamine > 8 mg/ml

Healthy Subjects - Exclusion Criteria:

  • Use of steroids in the previous 6 weeks
  • Current or ex-smokers with ≥ 10 pack-years (≥ 2 pipe pack-years), ex smokers who stopped less than 1 year ago
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT00116311
Other Study ID Numbers METc2004-253
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Groningen Research Institute for Asthma and COPD
Collaborators Not Provided
Investigators
Principal Investigator: Dirkje S Postma, prof. MD PhD University Medical Center Groningen, Department of Pulmonology, hanzeplein 1, 9713 GZ Groningen, The Netherlands
PRS Account Groningen Research Institute for Asthma and COPD
Verification Date March 2007