Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509197
Status:
TERMINATED
Last Update Posted:
2016-08-15
First Post:
2007-07-27
Brief Title:
Should Non-eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids
Sponsor:
Université de Montréal
Organization:
Université de Montréal
Study Overview
Official Title:
Should Non-eosinophilic Asthmatic Subjects be Treated With Inhaled Corticosteroids
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to complete the recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The efficacy of inhaled corticosteroids ICS in asthmatic subjects showing no sputum eosinophils is controversial The broad aim of this study is to assess whether ICS alone or in combination with long-acting beta-2 agonists are an effective treatment in non-eosinophilic asthmatic subjects Methods The investigators will perform a randomized double-blind placebo-controlled multicenter study comparing the efficacy of ICS and placebo for 4 weeks followed by a 4-week open treatment period with ICSsalmeterol in steroid-naïve asthmatic subjects without sputum eosinophilia The primary outcome will be the the Asthma Control Questionnaire ACQ score after four weeks of treatment by ICS or placebo
This study will determine whether or not non-eosinophilic asthmatic subjects respond to ICS and if they further benefit from the addition of a long-acting beta-2 agonists This study will also determine whether or not the assessment of airway inflammation should be performed in every asthmatic patient in order to give the most appropriate treatment
This study will determine whether or not non-eosinophilic asthmatic subjects respond to ICS and if they further benefit from the addition of a long-acting beta-2 agonists This study will also determine whether or not the assessment of airway inflammation should be performed in every asthmatic patient in order to give the most appropriate treatment
Detailed Description:
General objective To assess whether inhaled corticosteroids alone or in combination with long-acting beta-2 agonists are an effective treatment in non-eosinophilic asthmatic subjects
Specific objective 1 To compare the change in clinical and functional outcomes after treatment with fluticasone or placebo in non-eosinophilic asthmatic subjects
Specific objective 2 To assess whether the combination of inhaled corticosteroids ICS and with long-acting beta-2 agonists provides an improvement of asthma control compared to the treatment with ICS or placebo in non-eosinophilic asthmatics
Hypothesis Treatment with ICS induces a significant clinical and physiologic improvement of non-eosinophilic asthmatic subjects ICSSalmeterol also provides a clinical and physiologic benefit compared to placebo
Primary end point Asthma Control Questionnaire ACQ score after 4 weeks of treatment with ICS or placebo
The Asthma Control Questionnaire has been chosen as a primary outcome since it is the most relevant clinical measure to assess asthma control over a short period of time In patients whose asthma is stable between clinic visits reliability of the ACQ is high intraclass correlation coefficient ICC090 Furthermore the questionnaire is also very responsive to changes in asthma control7 Therefore this is the ideal tool to assess and compare the changes in asthma control over a short period of time This instrument has the advantage of including both asthma symptoms as well as forced expiratory flow in one second FEV1 A change of ACQ of 05 has been shown to be clinically significant Therefore we will be able to assess whether or not a treatment with ICS has the ability to significantly improve asthma control in non-eosinophilic asthmatic subjects The questionnaire is provided in appendix III Other functional and clinical outcomes such as quality of life FEV1 provocative concentration of methacholine inducing a 20 fall in FEV1 PC20 number of rescue medication and number of asthma exacerbations will also be assessed as secondary outcomes
The study has two steps The first step will be a randomized double-blind placebo-controlled multicenter study comparing the efficacy of ICS and placebo for 4 weeks in asthmatic subjects without sputum eosinophilia followed by an open ICSsalmeterol 4-week treatment for all subjects See study design in appendix III
Inclusion criteria One hundred subjects will be enrolled
Specific objective 1 To compare the change in clinical and functional outcomes after treatment with fluticasone or placebo in non-eosinophilic asthmatic subjects
Specific objective 2 To assess whether the combination of inhaled corticosteroids ICS and with long-acting beta-2 agonists provides an improvement of asthma control compared to the treatment with ICS or placebo in non-eosinophilic asthmatics
Hypothesis Treatment with ICS induces a significant clinical and physiologic improvement of non-eosinophilic asthmatic subjects ICSSalmeterol also provides a clinical and physiologic benefit compared to placebo
Primary end point Asthma Control Questionnaire ACQ score after 4 weeks of treatment with ICS or placebo
The Asthma Control Questionnaire has been chosen as a primary outcome since it is the most relevant clinical measure to assess asthma control over a short period of time In patients whose asthma is stable between clinic visits reliability of the ACQ is high intraclass correlation coefficient ICC090 Furthermore the questionnaire is also very responsive to changes in asthma control7 Therefore this is the ideal tool to assess and compare the changes in asthma control over a short period of time This instrument has the advantage of including both asthma symptoms as well as forced expiratory flow in one second FEV1 A change of ACQ of 05 has been shown to be clinically significant Therefore we will be able to assess whether or not a treatment with ICS has the ability to significantly improve asthma control in non-eosinophilic asthmatic subjects The questionnaire is provided in appendix III Other functional and clinical outcomes such as quality of life FEV1 provocative concentration of methacholine inducing a 20 fall in FEV1 PC20 number of rescue medication and number of asthma exacerbations will also be assessed as secondary outcomes
The study has two steps The first step will be a randomized double-blind placebo-controlled multicenter study comparing the efficacy of ICS and placebo for 4 weeks in asthmatic subjects without sputum eosinophilia followed by an open ICSsalmeterol 4-week treatment for all subjects See study design in appendix III
Inclusion criteria One hundred subjects will be enrolled
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