Fluctuation Analyses of Asthma Patients With Biologics Use

NCT06024707 | Unknown

• 1 other identifier: NL83718.018.23
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

Fluctuation Pattern; Spirometry; FeNO; Impulse oscillometry

Outcome Measures

Primary Outcomes (8)

• 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.

  2-3 months

• 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.

  2-3 months

• 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.

  2-3 months

• 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

  at 4-6 months after start treatment with biological

• trend of Asthma Control Questionnaire

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

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

• 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

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

• 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)

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

• trend of PESAM questionnaire

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

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

Secondary Outcomes (9)

• FEV1 as measured with standard Spirometry

  3 or 4 times during 2-3 months

• FVC as measured with standard Spirometry

  3 or 4 times during 2-3 months

• Standard Impulse oscillometry

  3 or 4 times during 2-3 months

• standard FeNO

  3 or 4 times during 2-3 months

• lab values from standard care before study

  At inclusion

Other Outcomes (10)

• Demographics

  at inclusion

• Height

  at inclusion

• Descriptives

  at inclusion

Study Arms (1)

Asthma patients

All asthma patients will be observed and receive their regular treatment

Drug: Biological Drug

Interventions

Biological Drug DRUG

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

Also known as: Mepolizumab, Omalizumab, Benralizumab, Dupilimab, Reslizumab

Asthma patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

MeSH Terms

Conditions

Asthma

Interventions

Biological Products; mepolizumab; Omalizumab; benralizumab; reslizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures; Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Els Weersink, Dr.

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arjen Pelgröm, MSc.

CONTACT

+31650922580; a.t.pelgrom@amsterdamumc.nl

Rene Lutter, Dr.

CONTACT

r.lutter@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary Physician

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: September 6, 2023
• Study Start: December 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 1, 2023

Record last verified: 2023-10