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LOMA: Long-Term Management of Asthma

NCT ID: NCT00182481

Last Updated: 2005-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2001-09-30

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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asthma treatment induced sputum cell counts asthma exacerbations eosinophilic bronchitis non-eosinophilic bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Induced sputum cell counts

Intervention Type PROCEDURE

inhaled corticosteroids and other asthma drugs

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Principal Investigators

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Frederick E Hargreave, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Louis-Philippe Boulet, MD

Role: PRINCIPAL_INVESTIGATOR

Laval University, Sainte-Foy, Quebec

Andre Cartier, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital du Sacre Coeur, Montreal, PQ

Catherine Lemiere, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital du Sacre Coeur, Montreal, PQ

Marcia Pizzichini, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Santa Catarina, Florianopolis, Brazil

Emilio Pizzichini, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Santa Catarina, Florianopolis, Brazil

Locations

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Firestone Institute for Respiratory Health, St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 10673188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11348936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12480423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12361359 (View on PubMed)

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

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 16507847 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8977499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10392993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10759441 (View on PubMed)

Other Identifiers

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MCT-44158

Identifier Type: -

Identifier Source: secondary_id

RP#97-1549

Identifier Type: -

Identifier Source: org_study_id