Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-08
Brief Title:
Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients With Severe Asthma on Biologics
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients With Severe Asthma on Biologics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
OUTERSPACE-3
Brief Summary:
Severe refractory asthma affects about 35 of asthma patients often necessitating biologic therapy in addition to standard treatment However little is understood about maintenance and reliever inhalation medication adherence in these cases which might impact overall biologic response Objectively monitoring inhalation medication adherence remains a significant challenge The Smart AeroChamber device capable of measuring adherence and inhalation technique is untested in severe asthma patients on biologics presenting a potentially cost-effective solution to monitor adherence and better understand treatment response
This study aims to assess the feasibility of the Smart AeroChamber device in severe asthma patients on biologic therapy with objectives to
1 Evaluate inhalation medication adherence patterns and inhaler technique and comparing that adherence data with traditional measures eg the Test of Adherence to Inhalers TAI and an inhalation technique checklist
2 Investigate the association between inhaled medication adherence and clinical outcomes such as exacerbations short-acting beta-agonists SABA use oral corticosteroids use OCS Fractional Exhaled Nitric Oxide FeNO blood eosinophil count and Asthma Control Questionnaire ACQ scores
3 Assess patient and healthcare provider satisfaction and usability of the Smart AeroChamber device
The study design is prospective and observational with a sample size of 110 adult patients diagnosed with severe asthma using biologic therapy Participants will be followed for 12 months during which they will receive Smart AeroChamber devices These devices will measure medication adherence and inhaler technique and undergo assessments of clinical outcomes at regular intervals Usability and satisfaction will also be evaluated using the Systems Usability Scale SUS in patients and healthcare professionals
The study will be conducted across five severe asthma clinics in the Netherlands Data analysis will involve comparing the inhalation medication adherence data with traditional measures for adherence and inhalation technique assessing clinical outcomes and evaluating usability and satisfaction The findings from this study will provide insights into the feasibility and effectiveness of using digital devices like the Smart AeroChamber to support medication adherence and possibly improve outcomes in patients with severe asthma on biologic therapy
This study aims to assess the feasibility of the Smart AeroChamber device in severe asthma patients on biologic therapy with objectives to
1 Evaluate inhalation medication adherence patterns and inhaler technique and comparing that adherence data with traditional measures eg the Test of Adherence to Inhalers TAI and an inhalation technique checklist
2 Investigate the association between inhaled medication adherence and clinical outcomes such as exacerbations short-acting beta-agonists SABA use oral corticosteroids use OCS Fractional Exhaled Nitric Oxide FeNO blood eosinophil count and Asthma Control Questionnaire ACQ scores
3 Assess patient and healthcare provider satisfaction and usability of the Smart AeroChamber device
The study design is prospective and observational with a sample size of 110 adult patients diagnosed with severe asthma using biologic therapy Participants will be followed for 12 months during which they will receive Smart AeroChamber devices These devices will measure medication adherence and inhaler technique and undergo assessments of clinical outcomes at regular intervals Usability and satisfaction will also be evaluated using the Systems Usability Scale SUS in patients and healthcare professionals
The study will be conducted across five severe asthma clinics in the Netherlands Data analysis will involve comparing the inhalation medication adherence data with traditional measures for adherence and inhalation technique assessing clinical outcomes and evaluating usability and satisfaction The findings from this study will provide insights into the feasibility and effectiveness of using digital devices like the Smart AeroChamber to support medication adherence and possibly improve outcomes in patients with severe asthma on biologic therapy
Detailed Description:
Rationale
Despite the availability of effective inhaled medications 15 of asthma patients remain uncontrolled on medium to high dose inhaled corticosteroids ICS and LABA comprising difficult-to-treat asthma and severe refractory asthma groups GINA guidelines stress the importance of assessing adherence and technique before step-up treatment due to associated risks and costs
Research underscores the efficacy and cost-effectiveness of investing in adherence and technique support particularly in this population However there is limited understanding of ICS adherence during biologic therapy despite its increasing use Studies on biologics like mepolizumab suggest associations between ICS adherence and improved outcomes while data on others like benralizumab are less conclusive
Indeed non-adherence and poor technique is widely reported in patients with all severities of asthma and is associated with increased morbidity and economic burden Objectively assessing and enhancing adherence remains one of the major challenges for physicians pharmacists and nurses Limited studies on digital tools for adherence management exist particularly for pMDIs in combination with spacers Digital technologies are promising in addressing these challenges but studies on devices capable of objectively measuring adherence and technique especially in patients using pMDIs are lacking The Smart AeroChamber device presents an innovative solution showing potential in clinical trials for asthma and COPD The Smart AeroChamber is a CE-certified device However its application in severe asthma patients on biologics remains unexplored presenting an opportunity to enhance adherence support and treatment outcomes in this cost-sensitive population
The aim
This study aims to evaluate the feasibility of using a Smart Spacer device in patients with severe asthma who are on biologic therapy The research aims to achieve several objectives
1 Assess medication adherence patterns and inhaler technique using the Smart Spacer device and compare the data with traditional adherence measures such as the Test of Adherence to Inhalers TAI and an inhalation technique checklist
2 Evaluate the association between adherence measured by the Smart Spacer device and various clinical outcomes including exacerbations use of short-acting beta agonists SABA and oral corticosteroids OCS Fractional exhaled Nitric Oxide FeNO results blood eosinophil count and asthma control questionnaire ACQ scores
3 Assess the usability and satisfaction of patients and healthcare providers with the Smart Spacer device using the System Usability Scale SUS
Study Design
This study adopts a prospective observational design
Inclusion Criteria
Participants eligible for inclusion are adults aged over 18 years diagnosed with severe asthma by a physician according to GINA guidelines They must be using a biologic medication omalizumab mepolizumab reslizumab benralizumab dupilumab or tezepelumab and medium or high dose ICS LABA with or without LAMA andor SABA via pMDI in combination with a spacer Additionally participants must be willing to provide informed consent
Exclusion Criteria
Participants are excluded from participation when they are unable to sufficiently understand and read the Dutch language being pregnant or being terminally ill
Sample Size
The study aims to include a total of 110 patients
Setting
The study is conducted in five severe asthma clinics across various regions of the Netherlands Medical Center Leeuwarden Martini Hospital Groningen Isala Zwolle Sint Franciscus Gasthuis and University Medical Centrer Groningen
Baseline Assessment
Participants undergo characterization during an intake visit to the severe asthma clinic including demographic data medical history spirometry tests FeNO measurement blood eosinophil count ACQ assessment adherence evaluation using TAI and inhaler technique assessment via checklist Subsequently participants receive two fully charged smart spacers one for each period of three months along with instructions for use
Follow-up
After 4 weeks participants are contacted to check the functionality of the smart spacer and receive assistance if needed A follow-up call at 3-months and 9-months into the study remind participants to switch to the next smart spacer A physical visit is scheduled at the 6-month mark for further assessment including ACQ administration and collection of smart spacers for replacement
End of Study Assessment
At the end of the 12-month study period participants undergo a final physical visit for assessment of various parameters including FeNO blood eosinophil count lung function ACQ score inhaler technique and documentation of exacerbations and OCS use Smart spacer data analysis is conducted centrally and feedback is provided to study sites Additionally usability and satisfaction surveys are completed by patients and study nurses
Despite the availability of effective inhaled medications 15 of asthma patients remain uncontrolled on medium to high dose inhaled corticosteroids ICS and LABA comprising difficult-to-treat asthma and severe refractory asthma groups GINA guidelines stress the importance of assessing adherence and technique before step-up treatment due to associated risks and costs
Research underscores the efficacy and cost-effectiveness of investing in adherence and technique support particularly in this population However there is limited understanding of ICS adherence during biologic therapy despite its increasing use Studies on biologics like mepolizumab suggest associations between ICS adherence and improved outcomes while data on others like benralizumab are less conclusive
Indeed non-adherence and poor technique is widely reported in patients with all severities of asthma and is associated with increased morbidity and economic burden Objectively assessing and enhancing adherence remains one of the major challenges for physicians pharmacists and nurses Limited studies on digital tools for adherence management exist particularly for pMDIs in combination with spacers Digital technologies are promising in addressing these challenges but studies on devices capable of objectively measuring adherence and technique especially in patients using pMDIs are lacking The Smart AeroChamber device presents an innovative solution showing potential in clinical trials for asthma and COPD The Smart AeroChamber is a CE-certified device However its application in severe asthma patients on biologics remains unexplored presenting an opportunity to enhance adherence support and treatment outcomes in this cost-sensitive population
The aim
This study aims to evaluate the feasibility of using a Smart Spacer device in patients with severe asthma who are on biologic therapy The research aims to achieve several objectives
1 Assess medication adherence patterns and inhaler technique using the Smart Spacer device and compare the data with traditional adherence measures such as the Test of Adherence to Inhalers TAI and an inhalation technique checklist
2 Evaluate the association between adherence measured by the Smart Spacer device and various clinical outcomes including exacerbations use of short-acting beta agonists SABA and oral corticosteroids OCS Fractional exhaled Nitric Oxide FeNO results blood eosinophil count and asthma control questionnaire ACQ scores
3 Assess the usability and satisfaction of patients and healthcare providers with the Smart Spacer device using the System Usability Scale SUS
Study Design
This study adopts a prospective observational design
Inclusion Criteria
Participants eligible for inclusion are adults aged over 18 years diagnosed with severe asthma by a physician according to GINA guidelines They must be using a biologic medication omalizumab mepolizumab reslizumab benralizumab dupilumab or tezepelumab and medium or high dose ICS LABA with or without LAMA andor SABA via pMDI in combination with a spacer Additionally participants must be willing to provide informed consent
Exclusion Criteria
Participants are excluded from participation when they are unable to sufficiently understand and read the Dutch language being pregnant or being terminally ill
Sample Size
The study aims to include a total of 110 patients
Setting
The study is conducted in five severe asthma clinics across various regions of the Netherlands Medical Center Leeuwarden Martini Hospital Groningen Isala Zwolle Sint Franciscus Gasthuis and University Medical Centrer Groningen
Baseline Assessment
Participants undergo characterization during an intake visit to the severe asthma clinic including demographic data medical history spirometry tests FeNO measurement blood eosinophil count ACQ assessment adherence evaluation using TAI and inhaler technique assessment via checklist Subsequently participants receive two fully charged smart spacers one for each period of three months along with instructions for use
Follow-up
After 4 weeks participants are contacted to check the functionality of the smart spacer and receive assistance if needed A follow-up call at 3-months and 9-months into the study remind participants to switch to the next smart spacer A physical visit is scheduled at the 6-month mark for further assessment including ACQ administration and collection of smart spacers for replacement
End of Study Assessment
At the end of the 12-month study period participants undergo a final physical visit for assessment of various parameters including FeNO blood eosinophil count lung function ACQ score inhaler technique and documentation of exacerbations and OCS use Smart spacer data analysis is conducted centrally and feedback is provided to study sites Additionally usability and satisfaction surveys are completed by patients and study nurses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None