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Asthma/Steroid Withdrawal Study

This study has been terminated.
(This project will resume upon the completion of other research committments.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00395239
First Posted: November 2, 2006
Last Update Posted: May 26, 2016
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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Irvin Mayers, University of Alberta
  Purpose

The investigators propose to study the patterns of metabolite changes in subjects with asthma to determine if there is a predictable pattern prior to, and post, clinical exacerbation.

Hypothesis: 1. Metabolite profiles will change prior to detection of a clinical exacerbation in subjects with asthma.

2. There will be a measurable temporal delay before metabolite profiles return to baseline following anti-inflammatory therapy of an exacerbation of asthma.


Condition Intervention Phase
Asthma Drug: inhaled corticosteroid Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Temporal Sequence of Inflammatory Mediators During a Controlled Exacerbation of Asthma by Steroid Withdrawal.

Further study details as provided by Irvin Mayers, University of Alberta:

Primary Outcome Measures:
  • Metabolite changes in induced sputum [ Time Frame: 20 weeks ]
  • Metabolite changes in urine [ Time Frame: 20 weeks ]

Secondary Outcome Measures:
  • Health related quality of life status [ Time Frame: 20 weeks ]
  • Peak expiratory flow measurements [ Time Frame: 20 weeks ]

Enrollment: 6
Study Start Date: October 2006
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: inhaled corticosteroid
Fluticasone; Budesonide; Ciclesonide Dosage and frequency is patient dependant.
Other Name: Flovent; Pulmicort; Alvesco.

  Show Detailed Description

  Eligibility

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
Criteria

Inclusion Criteria:

  1. Non-smoker (less than 1 pack-year).
  2. Age greater than 18 years old.
  3. Ability to obtain informed consent.
  4. Pulmonary Function Tests demonstrating greater than 12% FEV1 reversibility following beta agonist OR a methacholine challenge consistent with airways hyper-reactivity.
  5. Evidence of atopy on standardized skin test battery.
  6. Mild to moderate persistent asthma classification by GINA guidelines.
  7. No severe exacerbations in the preceding 3 months (defined as emergency room visit, course of oral prednisone or hospitalization).
  8. Access to internet.

Exclusion Criteria:

  1. Unstable asthma.
  2. Patient not on inhaled corticosteroids.
  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): NCT00395239


Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
GlaxoSmithKline
Investigators
Principal Investigator: Irvin Mayers, MD, FRCPC University of Alberta
  More Information

Responsible Party: Irvin Mayers, Dr. Irvin Mayers, University of Alberta
ClinicalTrials.gov Identifier: NCT00395239     History of Changes
Other Study ID Numbers: Asthma/Steroid Withdrawal
First Submitted: November 1, 2006
First Posted: November 2, 2006
Last Update Posted: May 26, 2016
Last Verified: August 2010

Keywords provided by Irvin Mayers, University of Alberta:
Asthma
Inhaled corticosteroid
ICS
Metabolites
Induced sputum
Virtual Asthma Clinic

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