AzTrials
AzTrials

AsthmaFABLENCT06024707

Fluctuation Analyses of Asthma Patients With Biologics Use

An observational study of Asthma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Asthma
What is being tested?
Biological Drug
How many people
48 participants
Where
No sites listed yet
Study dates
Dec 2023to 30 Sep 2024
Phase
Observational
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Patients with severe asthma who will start treatment with a biological from 18-60 years old.

Who may be able to join

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • Severe asthma based on the definition by the 2022 GINA guidelines.
  • Will start treatment with a biological
  • 18-60 years old
  • Subject should be willing and able to perform the lung function tests and other study-related procedures and comply with study protocol requirements.
  • Apart from their asthma, subjects should be generally healthy with no history of a clinically relevant medical condition that in the opinion of the investigator might interfere with successful study conduct and no clinically relevant abnormalities on medical history.
  • Subjects should provide a signed and dated informed consent

Who cannot join

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • Has been tested positively for COVID-19 in the past month or has not fully recovered from an earlier COVID-19 infection (e.g. post-covid syndrome)
  • Has been treated with oral corticosteroids as high-dose therapy in the 6 weeks before visit 1.
  • Has been treated with another biologic within 3 months before start treatment with new biological (e.g. 2 months before the start of the study participation)
  • Not able to perform spirometry/IOS/FeNO tests correctly
  • Not able to handle Respicorder well
Show all 10Show fewer
  • Subject is a current smoker/vaper, uses recreational drugs, or has >10 packyears
  • Subject is anticipated not to comply with study protocol or other aspects of the study (at the discretion of the investigator)
  • Participation to the study is not medically responsible according to the study physician and/or principle investigator
  • Inability to read and/or understand the Dutch language

Trial locations and contacts

No sites are listed yet.

Arjen Pelgröm, MSc. contact

+31650922580

a.t.pelgrom@amsterdamumc.nl

Rene Lutter, Dr. contact

r.lutter@amsterdamumc.nl

About this study

Official title: Early Detection of the Effectiveness of Treatment With Biologicals in Patients With Severe Asthma Using Fluctuation Analysis of Biomarkers

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.

Read the 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 parameters/endpoints: The Respicorder device measures standard spirometry (FEV1, FVC), IOS parameters and FeNO, which will be used for fluctuation analysis. The Asthma Control Questionnaire (ACQ),Asthma 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.

Conditions
Asthma
Being tested
Biological Drug
Keywords
Fluctuation Pattern, Spirometry, FeNO, Impulse oscillometry
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological DrugDrug

    Also called Mepolizumab, Omalizumab, Benralizumab, Dupilimab

    This intervention is part of regular treatment, subjects will be included if they get this treatment.

Study groups in NCT06024707
Study groupRoleWhat they receive
Asthma patientsAll asthma patients will be observed and receive their regular treatment
Receives: Drug: Biological Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fluctuation pattern of spirometry

    Subjects will perform spirometry measurements 2x a day. This data will be used to create a fluctuation pattern of the FEV1(L) and FVC (L). The change in fluctuation pattern before and after start of treatment will be compared between responders and non-responders to treatment with a biological. The fluctuation pattern cannot be described as one parameter, but is a combination of several properties (phase-space plot, entropy). This study has an explorative nature that will aim to assess how such a fluctuation pattern can be described.

    Measured: 2-3 months

  2. Fluctuation pattern of FeNO

    Subjects will perform FeNO measurements 2x a day. This data will be used to create a fluctuation pattern of FeNO (ppb). The change in fluctuation pattern before and after start of treatment will be compared between responders and non-responders to treatment with a biological. The fluctuation pattern cannot be described as one parameter, but is a combination of several properties (phase-space plot, entropy). This study has an explorative nature that will aim to assess how such a fluctuation pattern can be described.

    Measured: 2-3 months

  3. Fluctuation pattern of IOS

    Subjects will perform impulse oscillometry (IOS) measurements 2x a day. This data will be used to create a fluctuation pattern of the IOS parameters (R5, R20, X5, Fs, AX etc). The change in fluctuation pattern before and after start of treatment will be compared between responders and non-responders to treatment with a biological. The fluctuation pattern cannot be described as one parameter, but is a combination of several properties and parameters (phase-space plot, entropy). This study has an explorative nature that will aim to assess how such a fluctuation pattern can be described.

    Measured: 2-3 months

  4. Treatment success with biological

    Treatment success is defined if two or more of the following are true:

    • A decrease of ACQ score of 0,5 points or an ACQ≤1,5 after 4-6 months compared to visit 2 (start of treatment with biological) and/or
    • An increase of SAQ score of 0,5 points after 4-6 months compared to visit 2 (start of treatment with biological) and/or
    • Minimal 30% reduction of dose of maintenance treatment with OCS after 4-6 months compared to visit 2 (start of treatment with biological)
    • and/or Decrease in exacerbation rate in the 4-6 months after visit 2 compared to the same period (4-6 months) before visit 2

    Measured: at 4-6 months after start treatment with biological

  5. trend of Asthma Control Questionnaire

    average of 7 questions regarding asthma control (scorerange 0-6), higher score means worse asthma control

    Measured: 1x a week for 2-3 months + at 4-6 months after start treatment with biological

  6. trend of Asthma Quality of Life Questionnaire

    average of 32 questions regarding impact of asthma on quality of life (scorerange 1-7), higher score means better quality of life

    Measured: 1x a week for 2-3 months + at 4-6 months after start treatment with biological

  7. trend of Severe Asthma Questionnaire

    SAQ-score: average of 16 questions regarding severe asthma (scorerange 1-7), higher score means better quality of life.

    SAQ-global: score representing overall satisfaction (scorerange 0-100)

    Measured: 1x a week for 2-3 months + at 4-6 months after start treatment with biological

  8. trend of PESAM questionnaire

    Patient Experience and SAtisfaction with Medication (PESAM) represents patients satisfaction with the treatment with the biological

    Measured: at 1+ 2 (if applicable) + 4-6 months after start treatment with biological

Secondary outcomes (9)

  1. FEV1 as measured with standard Spirometry

    Forced Expiratory Volume in one second measured with standard spirometry with standard lung function equipment during every visit

    Measured: 3 or 4 times during 2-3 months

  2. FVC as measured with standard Spirometry

    Forced vital capacity measured with standard spirometry with standard lung function equipment during every visit

    Measured: 3 or 4 times during 2-3 months

  3. Standard Impulse oscillometry

    IOS measured with standard equipment during every visit

    Measured: 3 or 4 times during 2-3 months

  4. standard FeNO

    FeNO measured with standard equipment during every visit

    Measured: 3 or 4 times during 2-3 months

  5. lab values from standard care before study

    for example blood eosinophil count

    Measured: At inclusion

  6. lab values from standard care during study

    for example blood eosinophil count

    Measured: at 4-6 months after start treatment with biological

  7. Rate of medication reduction after the start of treatment with the biological

    The medication a patient used in the 6 months before inclusion will compared to the medication use thoughout the study period until follow-up (4-6 months after start treatment with biological)

    Measured: At inclusion

  8. Respicorder adherence (% of possible measurements actually performed)

    Do patients perform the measurements with the Respicorder as scheduled (2x a day). This will be reported as a percentage.

    Measured: 2-3 months

  9. Respicorder qualitative feedback

    What is the user experience with the Respicorder. This will be an open question(s) to the patients.

    Measured: 2-3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2023
  2. Study startDec 2023 (estimated)
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06024707
Sponsor's protocol ID
NL83718.018.23
Acronym
FABLE
Status last verified
Oct 2023
First submitted
20 Jun 2023
Last updated
1 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Arjen Pelgröm, MSc. (+31650922580, a.t.pelgrom@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluctuation pattern of spirometry (time frame: 2-3 months). The study lists 8 primary outcomes in all. 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 NCT06024707.

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 1 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in