Clinical trial NCT00182481: LOMA: Long-Term Management of Asthma
Official title: Long Term Management of Asthma (LOMA) Study- How Useful is the Sputum Count Compared With the Usual Clincal Variables?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma treatment
induced sputum cell counts
asthma exacerbations
eosinophilic bronchitis
non-eosinophilic bronchitis
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-16
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
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 outcomes:
measure: Secondary outcomes were
measure: The cellular type of exacerbation that was influenced,
measure: The severity of asthma that was helped,
measure: The dose of inhaled corticosteroid that was required,
measure: Symptom control,
measure: Quality of life,
measure: FEV1
measure: Methacholine PC20,
measure: Exhaled NO,
measure: Cost effectiveness and cost benefit of sputum cell counts, Airway structural changes
measure: Skin bruising score.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health, St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: McMaster University
name: Frederick E Hargreave, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University, Sainte-Foy, Quebec
name: Louis-Philippe Boulet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital du Sacre Coeur, Montreal, PQ
name: Andre Cartier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital du Sacre Coeur, Montreal, PQ
name: Catherine Lemiere, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Santa Catarina, Florianopolis, Brazil
name: Marcia Pizzichini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Santa Catarina, Florianopolis, Brazil
name: Emilio Pizzichini, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Parameswaran K, Pizzichini E, Pizzichini MM, Hussack P, Efthimiadis A, Hargreave FE. Clinical judgement of airway inflammation versus sputum cell counts in patients with asthma. Eur Respir J. 2000 Mar;15(3):486-90. doi: 10.1034/j.1399-3003.2000.15.10.x.
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citation: Djukanovic R, Sterk PJ, Fahy JV, Hargreave FE. Standardised methodology of sputum induction and processing. Eur Respir J Suppl. 2002 Sep;37:1s-2s. doi: 10.1183/09031936.02.00000102. No abstract available.
citation: 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
citation: 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.
citation: Jayaram L, Pizzichini MM, Cook RJ, Boulet LP, Lemiere C, Pizzichini E, Cartier A, Hussack P, Goldsmith CH, Laviolette M, Parameswaran K, Hargreave FE. Determining asthma treatment by monitoring sputum cell counts: effect on exacerbations. Eur Respir J. 2006 Mar;27(3):483-94. doi: 10.1183/09031936.06.00137704.