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Asthma/Steroid Withdrawal Study

This study has been terminated.
(This project will resume upon the completion of other research committments.)
Information provided by (Responsible Party):
Irvin Mayers, University of Alberta Identifier:
First received: November 1, 2006
Last updated: May 24, 2016
Last verified: August 2010

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
Drug: inhaled corticosteroid
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Alberta:

Primary Outcome Measures:
  • Metabolite changes in induced sputum [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Metabolite changes in urine [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related quality of life status [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Peak expiratory flow measurements [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00395239

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

Responsible Party: Irvin Mayers, Dr. Irvin Mayers, University of Alberta Identifier: NCT00395239     History of Changes
Other Study ID Numbers: Asthma/Steroid Withdrawal 
Study First Received: November 1, 2006
Last Updated: May 24, 2016
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Inhaled corticosteroid
Induced sputum
Virtual Asthma Clinic

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on October 26, 2016