Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Asthma/Steroid Withdrawal Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Alberta.
Recruitment status was  Active, not recruiting
Information provided by:
University of Alberta Identifier:
First received: November 1, 2006
Last updated: August 30, 2010
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: Allocation: Non-Randomized
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.

Resource links provided by NLM:

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 ]

Estimated Enrollment: 20
Study Start Date: October 2006
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: January 2010 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: 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: August 30, 2010
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases processed this record on February 27, 2015