AsthmaNCT00182481
LOMA: Long-Term Management of Asthma
A study testing Induced sputum cell counts and inhaled corticosteroids and other asthma drugs in people with Asthma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Induced sputum cell counts and inhaled corticosteroids and other asthma drugs
- Type of treatment
- Surgery or procedure
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- Sep 1999to Sep 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Firestone Institute for Respiratory Health, St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
About this study
Official title: Long Term Management of Asthma (LOMA) Study- How Useful is the Sputum Count Compared With the Usual Clincal Variables?
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Induced sputum cell counts, inhaled corticosteroids and other asthma drugs
- Keywords
- asthma treatment, induced sputum cell counts, asthma exacerbations, eosinophilic bronchitis, non-eosinophilic bronchitis
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced sputum cell countsProcedure or surgery
inhaled corticosteroids and other asthma drugsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Quality of life,
FEV1
Methacholine PC20,
Exhaled NO,
Cost effectiveness and cost benefit of sputum cell counts, Airway structural changes
Skin bruising score.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 1999
- Study completionSep 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 112 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Frederick E Hargreave, MD, Principal investigator, McMaster UniversityLouis-Philippe Boulet, MD, Principal investigator, Laval University, Sainte-Foy, QuebecAndre Cartier, MD, Principal investigator, Hopital du Sacre Coeur, Montreal, PQCatherine Lemiere, MD, Principal investigator, Hopital du Sacre Coeur, Montreal, PQMarcia Pizzichini, MD, Principal investigator, Universidade Federal de Santa Catarina, Florianopolis, BrazilEmilio Pizzichini, MD, Principal investigator, Universidade Federal de Santa Catarina, Florianopolis, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182481
- Sponsor's protocol ID
- RP#97-1549
- Other IDs
- MCT-44158
- Status last verified
- Oct 2003
- First submitted
- 12 Sep 2005
- Last updated
- 16 Dec 2005
- Results posted
- No
Publications
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.
PubMed 8977499Pavord 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.
PubMed 10392993Parameswaran 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.
PubMed 10759441Belda 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.
PubMed 10673188Gibson 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.
PubMed 11348936Green 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.
PubMed 12480423Djukanovic 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.
PubMed 12361359Pizzichini 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.
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.
PubMed 16507847
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Management of Asthma (LOMA) Study- How Useful is the Sputum Count Compared With the Usual Clincal Variables?
- ClinicalTrials.gov ID
- NCT00182481
- Acronym / sponsor ID
- RP#97-1549
- Conditions
- Asthma
- Keywords
- asthma treatment, induced sputum cell counts, asthma exacerbations, eosinophilic bronchitis, non-eosinophilic bronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 1999
- Study completion
- Sep 2001
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induced sputum cell counts | Procedure or surgery | – |
| inhaled corticosteroids and other asthma drugs | Drug | – |
Primary outcome
Relative risk reduction for the occurence of the first exacerbation and the length of time without exacerbation during Phase 2 of the study.
11 secondary outcomes
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,
Quality of life,
FEV1
Methacholine PC20,
Exhaled NO,
Cost effectiveness and cost benefit of sputum cell counts, Airway structural changes
Skin bruising score.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2005.
- Background: PubMed 8977499Cockcroft 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.
- Background: PubMed 10392993Pavord 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.
- Background: PubMed 10759441Parameswaran 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.
- Background: PubMed 10673188Belda 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.
- Background: PubMed 11348936Gibson 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.
- Background: PubMed 12480423Green 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.
- Background: PubMed 12361359Djukanovic 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.
- Results publicationPizzichini 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
- Results publicationPizzichini 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.
- Results publication: PubMed 16507847Jayaram 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick E Hargreave, MD principal investigator
McMaster University
Louis-Philippe Boulet, MD principal investigator
Laval University, Sainte-Foy, Quebec
Andre Cartier, MD principal investigator
Hopital du Sacre Coeur, Montreal, PQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induced sputum cell counts and inhaled corticosteroids and other asthma drugs in people with Asthma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative risk reduction for the occurence of the first exacerbation and the length of time without exacerbation during Phase 2 of the study.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182481, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2005.