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Trial NCT00182481

Resource URI: http://static.linkedct.org/resource/trials/NCT00182481
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linkedct:brief_title LOMA: Long-Term Management of Asthma
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/1253>
linkedct: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.
linkedct: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 patientÂ’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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 70 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date September 2001
linkedct:enrollment 112 (xsd:int)
linkedct:firstreceived_date September 12, 2005
linkedct:id NCT00182481
rdfs:label Trial NCT00182481
linkedct:lastchanged_date December 15, 2005
linkedct:lead_sponsor_agency Hamilton Health Sciences
linkedct:location <http://static.linkedct.org/resource/location/19799>
linkedct:nct_id NCT00182481
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Long Term Management of Asthma (LOMA) Study- How Useful is the Sputum Count Compared With the Usual Clincal Variables?
linkedct:org_study_id RP#97-1549
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/16409>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/18623>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/2346>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/35876>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/37180>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/8087>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/415>
foaf:page <http://clinicaltrials.gov/show/NCT00182481>
linkedct:phase N/A
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/18636>
linkedct:reference <http://static.linkedct.org/resource/reference/10104>
linkedct:reference <http://static.linkedct.org/resource/reference/15718>
linkedct:reference <http://static.linkedct.org/resource/reference/4859>
linkedct:reference <http://static.linkedct.org/resource/reference/51363>
linkedct:reference <http://static.linkedct.org/resource/reference/6371>
linkedct:reference <http://static.linkedct.org/resource/reference/6853>
linkedct:reference <http://static.linkedct.org/resource/reference/992>
linkedct:secondary_id MCT-44158
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/103444>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/105924>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/108971>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/111633>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/112149>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/114764>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/32069>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/44770>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/46334>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/66777>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/92717>
linkedct:source McMaster University
linkedct:start_date September 1999
linkedct:study_design Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date October 2003