Asthma/Steroid Withdrawal Study

NCT00395239 | Terminated Phase 4 DMC

• 1 other identifier: Asthma/Steroid Withdrawal
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Inhaled corticosteroid; ICS; Metabolites; Induced sputum; Virtual Asthma Clinic

Outcome Measures

Primary Outcomes (2)

• Metabolite changes in induced sputum

  20 weeks

• Metabolite changes in urine

  20 weeks

Secondary Outcomes (2)

• Health related quality of life status

  20 weeks

• Peak expiratory flow measurements

  20 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: inhaled corticosteroid

Interventions

inhaled corticosteroid DRUG

Fluticasone; Budesonide; Ciclesonide Dosage and frequency is patient dependant.

Also known as: Flovent; Pulmicort; Alvesco.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unstable asthma.
• Patient not on inhaled corticosteroids.

Sponsors & Collaborators

• University of Alberta: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Budesonide; ciclesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; Pregnanes

Study Officials

• Irvin Mayers, MD, FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Irvin Mayers

Study Record Dates

• First Submitted: November 1, 2006
• First Posted: November 2, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 26, 2016

Record last verified: 2010-08

Locations

CA (1)