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LOMA: Long-Term Management of Asthma
Long Term Management of Asthma (LOMA) Study- How Useful is the Sputum Count Compared With the Usual Clincal Variables?
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- Firestone Institute for Respiratory Health, St. Joseph's Healthcare
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- History of asthma for at least one year,confirmed objectively.
- New or previously reviewed patients where the minimal treatment requirements have not been established within the last six months.
Exclusion Criteria:
- Smokers or ex-smokers for less than 6 months with a smoking history of more than 10 pack years.
- Other pulmonary co-morbidity (other than mild or moderate chronic airflow limitation).
- Subjects having a co-existing illness that precludes them from the study.
- Inability to give informed consent due to mental or legal reasons.
- Pregnancy or lactation.
- Known non-compliance with medications.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Relative risk reduction for the occurence of the first exacerbation and the length of time without exacerbation during Phase 2 of the study.
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Secundaire uitkomstmaten
Uitkomstmaat |
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FEV1
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Quality of life,
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Secondary outcomes were
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The cellular type of exacerbation that was influenced,
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The severity of asthma that was helped,
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The dose of inhaled corticosteroid that was required,
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Symptom control,
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Methacholine PC20,
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Exhaled NO,
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Cost effectiveness and cost benefit of sputum cell counts, Airway structural changes
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Skin bruising score.
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Frederick E Hargreave, MD, McMaster University
- Hoofdonderzoeker: Louis-Philippe Boulet, MD, Laval University, Sainte-Foy, Quebec
- Hoofdonderzoeker: Andre Cartier, MD, Hopital du Sacre Coeur, Montreal, PQ
- Hoofdonderzoeker: Catherine Lemiere, MD, Hopital du Sacre Coeur, Montreal, PQ
- Hoofdonderzoeker: Marcia Pizzichini, MD, Universidade Federal de Santa Catarina, Florianopolis, Brazil
- Hoofdonderzoeker: Emilio Pizzichini, MD, Universidade Federal de Santa Catarina, Florianopolis, Brazil
Publicaties en nuttige links
Algemene publicaties
- Green RH, Brightling CE, McKenna S, Hargadon B, Parker D, Bradding P, Wardlaw AJ, Pavord ID. Asthma exacerbations and sputum eosinophil counts: a randomised controlled trial. Lancet. 2002 Nov 30;360(9347):1715-21. doi: 10.1016/S0140-6736(02)11679-5.
- 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.
- Pavord ID, Brightling CE, Woltmann G, Wardlaw AJ. Non-eosinophilic corticosteroid unresponsive asthma. Lancet. 1999 Jun 26;353(9171):2213-4. doi: 10.1016/S0140-6736(99)01813-9. No abstract available.
- 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.
- Belda J, Leigh R, Parameswaran K, O'Byrne PM, Sears MR, Hargreave FE. Induced sputum cell counts in healthy adults. Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):475-8. doi: 10.1164/ajrccm.161.2.9903097.
- Cockcroft DW, Swystun VA. Asthma control versus asthma severity. J Allergy Clin Immunol. 1996 Dec;98(6 Pt 1):1016-8. doi: 10.1016/s0091-6749(96)80185-0. No abstract available.
- 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.
- Gibson PG, Simpson JL, Saltos N. Heterogeneity of airway inflammation in persistent asthma : evidence of neutrophilic inflammation and increased sputum interleukin-8. Chest. 2001 May;119(5):1329-36. doi: 10.1378/chest.119.5.1329.
- 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.
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RP#97-1549
- MCT-44158
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