LOMA: Long-Term Management of Asthma

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182481
First received: September 12, 2005
Last updated: December 15, 2005
Last verified: October 2003
  Purpose

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.


Condition Intervention
Asthma
Procedure: Induced sputum cell counts
Drug: inhaled corticosteroids and other asthma drugs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Long Term Management of Asthma (LOMA) Study- How Useful is the Sputum Count Compared With the Usual Clincal Variables?

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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:
  • 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,
  • Quality of life,
  • FEV1
  • Methacholine PC20,
  • Exhaled NO,
  • Cost effectiveness and cost benefit of sputum cell counts, Airway structural changes
  • Skin bruising score.

Estimated Enrollment: 112
Study Start Date: September 1999
Estimated Study Completion Date: September 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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 ClinicalTrials.gov identifier: NCT00182481

Locations
Canada, Ontario
Firestone Institute for Respiratory Health, St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00182481     History of Changes
Other Study ID Numbers: RP#97-1549, MCT-44158
Study First Received: September 12, 2005
Last Updated: December 15, 2005
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
asthma treatment
induced sputum cell counts
asthma exacerbations
eosinophilic bronchitis
non-eosinophilic bronchitis

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2014