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LOMA: Long-Term Management of Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182481
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 16, 2005
Canadian Institutes of Health Research (CIHR)
Information provided by:
McMaster University

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Procedure: Induced sputum cell counts Drug: inhaled corticosteroids and other asthma drugs Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Long Term Management of Asthma (LOMA) Study- How Useful is the Sputum Count Compared With the Usual Clincal Variables?
Study Start Date : September 1999
Study Completion Date : September 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. 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 :
  1. Secondary outcomes were
  2. The cellular type of exacerbation that was influenced,
  3. The severity of asthma that was helped,
  4. The dose of inhaled corticosteroid that was required,
  5. Symptom control,
  6. Quality of life,
  7. FEV1
  8. Methacholine PC20,
  9. Exhaled NO,
  10. Cost effectiveness and cost benefit of sputum cell counts, Airway structural changes
  11. Skin bruising score.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00182481

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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)
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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 of Results:
Pizzichini MMM, Jayaram L, Pizzichini E, Boulet LP, Lemière C, Efithmiades A, Cartier A, Hargreave FE. O exame das células no escarro induzido pode alterar as exacerbações da asma? O estudo LOMA. Respirtory Society Meeting. Bahia- Brazil. J Bras Pneum 2004, 30: S24
Pizzichini MMM, Pizzichini E, Jayaram L, Boulet LP, Lemière C, Efithmiades A, Cartier A, Hargreave FE. Monitorando o tratamento da asma através do escarro induzido : efeito nas exacerbações. Latina America Thoracic Society Meeting, ALAT. Buenos Aires-Argentina. Arch de Bronconeumologia 2004, 40 S88-89.

Other Publications:
Layout table for additonal information Identifier: NCT00182481    
Other Study ID Numbers: RP#97-1549
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 16, 2005
Last Verified: October 2003
Keywords provided by McMaster University:
asthma treatment
induced sputum cell counts
asthma exacerbations
eosinophilic bronchitis
non-eosinophilic bronchitis
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases