Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182481
Status:
COMPLETED
Last Update Posted:
2005-12-16
First Post:
2005-09-12
Brief Title:
LOMA Long-Term Management of Asthma
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Long Term Management of Asthma LOMA Study- How Useful is the Sputum Count Compared With the Usual Clincal Variables
Status:
COMPLETED
Status Verified Date:
2003-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MCT-44158 | None | None | None |