Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06024707
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-01
First Post:
2023-06-20
Brief Title:
Fluctuation Analyses of Asthma Patients With Biologics Use
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Early Detection of the Effectiveness of Treatment With Biologicals in Patients With Severe Asthma Using Fluctuation Analysis of Biomarkers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
FABLE
Brief Summary:
The goal of this observational study is to compare the fluctuation patterns of biomarkers Spirometry FeNO IOS of responders and non-responders in asthma patients who will start treatment with a biologic The main question it aims to answer is Can fluctuation patterns of parameters for spirometry FeNO and IOS before and after starting treatment with biologics in patients with severe asthma be used to predict a successful intervention
Participants will measure Spirometry FeNO and IOS twice a day at home for 2 or 3 months starting one month before starting treatment with a biological
Participants will measure Spirometry FeNO and IOS twice a day at home for 2 or 3 months starting one month before starting treatment with a biological
Detailed Description:
SUMMARY
Rationale Treatment of patients with severe asthma has taken a new avenue with the introduction of biologics Currently treatment success with biologics may be around 75 and is determined by assessing various biomarkers after 4 to 6 months of treatment At a stable state biological processes dynamically fluctuate within certain borders which differ between asthma and healthy controls By exposure to the common cold virus we have shown that destabilizing the condition of asthma patients and healthy controls directly but temporarily changes the fluctuation patterns of biological processes We propose that treatment success also changes fluctuation patterns and that this occurs relatively fast after treatment is started By daily measurements of spirometry fraction of exhaled nitric oxide FeNO and impulse oscillometry IOS using the Respicorder device we expect to determine the effect of treatment at an early stage and limit prolonged treatment of patients with a non-effective biologic and the very high costs of these biologics
Objective To investigate the fluctuation patterns of different pulmonary parameters in patients with severe asthma before and after starting a treatment with biologics using daily measurements with the Respicorder device
Study design The study design is an observational cohort study that will include patients that are scheduled for an intervention with biologic treatment in standard care Patients will receive their standard treatment and will perform some extra measurements during their regular visits and they will perform measurements with the Respicorder device twice a day at home
Study population 48 patients with severe asthma between 18-60 years old who will start treatment with biologics
Main study parametersendpoints The Respicorder device measures standard spirometry FEV1 FVC IOS parameters and FeNO which will be used for fluctuation analysis The Asthma Control Questionnaire ACQAsthma Quality of Life Questionnaire AQLQ and Severe Asthma Questionnaire SAQ will be used to quantify asthma status Patients will be evaluated by their treating clinician after 4 and 6 months of treatment with a biological The outcome will be linked to the fluctuation patterns such that can be evaluated whether these patterns can be used to predict a successful treatment with a biologic
Secondary study parameters
Spirometry IOS and FeNO measurements with standard devices as done in standard care in the hospital will be used to compare with the Respicorder measurements Subjects will also be asked about their experience with the Respicorder
Nature and extent of the burden and risks associated with participation benefit and group relatedness The risk for adverse events due to participation in this study is minimal The daily additional measurements with the Respicorder device can be a burden to patients The Respicorder measurements take about 5 minutes which we consider as an acceptable burden given the expected impact of the study Subjects will also be subjected to measurements according to the standard protocol in clinical care
Rationale Treatment of patients with severe asthma has taken a new avenue with the introduction of biologics Currently treatment success with biologics may be around 75 and is determined by assessing various biomarkers after 4 to 6 months of treatment At a stable state biological processes dynamically fluctuate within certain borders which differ between asthma and healthy controls By exposure to the common cold virus we have shown that destabilizing the condition of asthma patients and healthy controls directly but temporarily changes the fluctuation patterns of biological processes We propose that treatment success also changes fluctuation patterns and that this occurs relatively fast after treatment is started By daily measurements of spirometry fraction of exhaled nitric oxide FeNO and impulse oscillometry IOS using the Respicorder device we expect to determine the effect of treatment at an early stage and limit prolonged treatment of patients with a non-effective biologic and the very high costs of these biologics
Objective To investigate the fluctuation patterns of different pulmonary parameters in patients with severe asthma before and after starting a treatment with biologics using daily measurements with the Respicorder device
Study design The study design is an observational cohort study that will include patients that are scheduled for an intervention with biologic treatment in standard care Patients will receive their standard treatment and will perform some extra measurements during their regular visits and they will perform measurements with the Respicorder device twice a day at home
Study population 48 patients with severe asthma between 18-60 years old who will start treatment with biologics
Main study parametersendpoints The Respicorder device measures standard spirometry FEV1 FVC IOS parameters and FeNO which will be used for fluctuation analysis The Asthma Control Questionnaire ACQAsthma Quality of Life Questionnaire AQLQ and Severe Asthma Questionnaire SAQ will be used to quantify asthma status Patients will be evaluated by their treating clinician after 4 and 6 months of treatment with a biological The outcome will be linked to the fluctuation patterns such that can be evaluated whether these patterns can be used to predict a successful treatment with a biologic
Secondary study parameters
Spirometry IOS and FeNO measurements with standard devices as done in standard care in the hospital will be used to compare with the Respicorder measurements Subjects will also be asked about their experience with the Respicorder
Nature and extent of the burden and risks associated with participation benefit and group relatedness The risk for adverse events due to participation in this study is minimal The daily additional measurements with the Respicorder device can be a burden to patients The Respicorder measurements take about 5 minutes which we consider as an acceptable burden given the expected impact of the study Subjects will also be subjected to measurements according to the standard protocol in clinical care
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