LOMA: Long-Term Management of Asthma

NCT00182481 | Completed

• 2 other identifiers: RP#97-1549MCT-44158
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (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 Outcomes (11)

• 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,

Interventions

Induced sputum cell counts PROCEDURE

inhaled corticosteroids and other asthma drugs DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

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

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (10)

• 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.

  PMID: 8977499 BACKGROUND

• 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.

  PMID: 10392993 BACKGROUND

• 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.

  PMID: 10759441 BACKGROUND

• 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.

  PMID: 10673188 BACKGROUND

• 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.

  PMID: 11348936 BACKGROUND

• 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.

  PMID: 12480423 BACKGROUND

• 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.

  PMID: 12361359 BACKGROUND

• 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

  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.

  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.

  PMID: 16507847 RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 1999
• Study Completion: September 1, 2001
• Last Updated: December 16, 2005

Record last verified: 2003-10

Locations

CA (1)