The Virtual Asthma Clinic

NCT00562081 | Terminated Phase 4

• 1 other identifier: M-2394
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with asthma can be effectively treated using an Internet-based management system as demonstrated by:

1. 1.Physician utilization (emergency department visits and unscheduled physician visits).
2. 2.Health-related quality of life scores.
3. 3.Global health care costs.
4. 4.Frequency of severe exacerbations and time to first exacerbation.
5. 5.Asthma control days.
6. 6.Patient education.

Conditions

Asthma

Keywords

asthma; Virtual Asthma Clinic; metabolites; asthma education

Outcome Measures

Primary Outcomes (3)

• Emergency department visits and unscheduled physician visits

  One year.

• Good asthma control days

  One year.

• Time to first severe exacerbation

  One year.

Secondary Outcomes (7)

• Morning peak expiratory flow

  One year.

• Percentage of days with symptoms

  One year.

• Percentage of nights with asthma awakenings

  One year.

• Number of rescue inhalations per week

  One year.

• Health related quality of life scores

  One year.

Study Arms (2)

1

PLACEBO COMPARATOR

Patient does not have 24/7 access to a Certified Asthma Educator.

Behavioral: Education

2

ACTIVE COMPARATOR

Patient has 24/7 access to a Certified Asthma Educator.

Behavioral: Education

Interventions

Education BEHAVIORAL

24/7 access to a Certified Asthma Educator

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosis of asthma at the time of enrolment.
• The forced expiratory volume in one second (FEV1) at base line will be at least 50 percent of the predicted value.
• Evidence of at least 12% increase in FEV1 following inhaled bronchodilator or airway hyperreactivity as defined by a standard methacholine challenge study.

You may not qualify if:

• Concurrent disease likely to require regular physician contact (e.g. congestive heart failure).
• A separate diagnosis or other pulmonary disease (e.g. pulmonary fibrosis or chronic bronchitis).
• An inability to access the Internet on a regular basis.
• Inability or unwillingness to give informed consent or to complete online health related quality of life questionnaires.

Sponsors & Collaborators

• University of Alberta: lead
• ASTHMA C Project: collaborator
• AstraZeneca: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Irvin Mayers, MD, FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: March 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 2, 2016

Record last verified: 2009-01

Locations

CA (1)