LOMA: Long-Term Management of Asthma

December 15, 2005 updated by: Hamilton Health Sciences Corporation

Long Term Management of Asthma (LOMA) Study- How Useful is the Sputum Count Compared With the Usual Clincal Variables?

The purpose of this study was to determine whether the use of induced sputum cell counts could guide treatment of asthma more effectively than the use of symptoms and breathing tests. The main outcomes where the time to the first exacerbation and the number of exacerbations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Airway inflammation is an important component of asthma. It influences other components which include symptoms and airway functional (physiological) measurements. It is the primary target of treatment. However, it does not correlate closely with symptoms, need for symptomatic bronchodilator relief, or the physiological abnormalities. Furthermore, it can be of different types. As a result, physicians are poor at recognizing its presence or type. This is important because eosinophilic inflammation is responsive to corticosteroid while non-eosinophilic is not responsive.

The most comprehensive non-invasive or relatively non-invasive measurement of airway inflammation is by spontaneous or induced sputum cell counts. These are reliable, valid and responsive, the qualities of good measurements. They might therefore be clinically useful to guide individual treatment. In the present study we investigated this issue. We compared their use, in comparison with the use only of symptoms and spirometry, in preventing exacerbations of asthma. We chose prevention of exacerbations as the most important clinical outcome because these have the greatest impact on patient's quality of life, morbidity and healthcare utilization. The study comprised two Phases. In Phase 1, the minimum treatment to control sputum eosinophilia (as well as clinical criteria) in the Sputum Strategy, and clinical criteria in the Clinical Strategy, were established. In Phase 2, this minimum treatment was maintained and patients were seen every 3 momths and at exacerbations. The primary outcomes were the relative risk reduction for the occurrence of the first exacerbation and the length of time without exacerbation over 18-20 months in Phase 2 of the study.

Study Type

Interventional

Enrollment

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Firestone Institute for Respiratory Health, St. Joseph's Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. History of asthma for at least one year,confirmed objectively.
  2. New or previously reviewed patients where the minimal treatment requirements have not been established within the last six months.

Exclusion Criteria:

  1. Smokers or ex-smokers for less than 6 months with a smoking history of more than 10 pack years.
  2. Other pulmonary co-morbidity (other than mild or moderate chronic airflow limitation).
  3. Subjects having a co-existing illness that precludes them from the study.
  4. Inability to give informed consent due to mental or legal reasons.
  5. Pregnancy or lactation.
  6. Known non-compliance with medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Relative risk reduction for the occurence of the first exacerbation and the length of time without exacerbation during Phase 2 of the study.

Secondary Outcome Measures

Outcome Measure
FEV1
Quality of life,
Secondary outcomes were
The cellular type of exacerbation that was influenced,
The severity of asthma that was helped,
The dose of inhaled corticosteroid that was required,
Symptom control,
Methacholine PC20,
Exhaled NO,
Cost effectiveness and cost benefit of sputum cell counts, Airway structural changes
Skin bruising score.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Frederick E Hargreave, MD, McMaster University
  • Principal Investigator: Louis-Philippe Boulet, MD, Laval University, Sainte-Foy, Quebec
  • Principal Investigator: Andre Cartier, MD, Hopital du Sacre Coeur, Montreal, PQ
  • Principal Investigator: Catherine Lemiere, MD, Hopital du Sacre Coeur, Montreal, PQ
  • Principal Investigator: Marcia Pizzichini, MD, Universidade Federal de Santa Catarina, Florianopolis, Brazil
  • Principal Investigator: Emilio Pizzichini, MD, Universidade Federal de Santa Catarina, Florianopolis, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Study Completion

September 1, 2001

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 16, 2005

Last Update Submitted That Met QC Criteria

December 15, 2005

Last Verified

October 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP#97-1549
  • MCT-44158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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