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Asthma/Steroid Withdrawal Study

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ClinicalTrials.gov Identifier: NCT00395239
Recruitment Status : Terminated (This project will resume upon the completion of other research committments.)
First Posted : November 2, 2006
Last Update Posted : May 26, 2016
Information provided by (Responsible Party):
Irvin Mayers, University of Alberta

Brief Summary:

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 or disease Intervention/treatment Phase
Asthma Drug: inhaled corticosteroid Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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.
Study Start Date : October 2006
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: inhaled corticosteroid
Fluticasone; Budesonide; Ciclesonide Dosage and frequency is patient dependant.
Other Name: Flovent; Pulmicort; Alvesco.

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

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

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

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.

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

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

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 Posted: November 2, 2006    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: August 2010

Keywords provided by Irvin Mayers, 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