AsthmaPROCLAIMNCT04114396
Poor Response to Monoclonal Therapy in Asthma
An observational study of Asthma, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Asthma affects 8% of the entire population. 4-5% of asthma sufferers have severe asthma, characterised by recurrent exacerbations (worsening of symptoms leading to the person having a bout of corticosteroids and/or antibiotics), significant symptoms and lack of response to the most widely used therapy… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Anti-IL5 Antibody and Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Dec 2018to 31 Jul 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the severe asthma clinic. Once the multidisciplinary team (MDT) have decided that the patient will be prescribed anti-IL5 therapy a patient information sheet (PIS) will be posted out by the clinical team. If the appointment with the clinical team is within days of the MDT, potential participant will be approached by a member of the research team and the study will be discussed and a patient information sheet will be given to the patient. Control participants will be recruited from our Respiratory Research Database and have agreed to be contacted for research. A poster will be created to be put up in Nottingham City Hospital, Queen's Medical Centre and at the University of Nottingham, UK.
Who may be able to join
- Aged 18 - 80 years old
- Able to give informed consent
- All patients identified as being suitable for anti-IL5 therapy by the asthma MDT will be considered for study enrolment.
- This assessment by the MDT for participants to be eligible includes:
- A measure of compliance with current asthma medication,
- Confirmation of asthma diagnosis
Show all 15Show fewer
- Suitability for anti-IL5 therapy based on blood eosinophil counts,
- Asthma exacerbation rates
- Prednisolone dose.
- Confirmation of treatment requires at least two asthma specialists to agree that this is the correct course of action
- Patients must first demonstrate over 75% compliance with inhaled and/or oral corticosteroid therapy
- The asthma MDT and difficult asthma clinic normally assess patients between 18-80 years so only patients in this age range will be approached.
- All patients will be able to give informed consent for study participation.
- Aged between 18-80 years old.
- Able to give informed consent
Who cannot join
- Pregnancy
- Pregnancy
- Underlying respiratory conditions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham Respiratory BRU
Nottingham, NG51PB
Yik L Pang, BMedSci, MBBS, MRCP, 01158231702, mszyp@exmail.nottingham.ac.uk
Mohammad R Ali, BSc, MRes, 0115 82 31339, mohammad.ali@nottingham.ac.uk
About this study
Official title: Investigating Poor Response to Monoclonal Therapy in Asthma
Asthma affects 8% of the entire population. 4-5% of asthma sufferers have severe asthma, characterised by recurrent exacerbations (worsening of symptoms leading to the person having a bout of corticosteroids and/or antibiotics), significant symptoms and lack of response to the most widely used therapy, corticosteroids.
There is now new types of treatments (antibody drugs) which are licensed to manage severe asthma such as Anti-IL5. There is evidence Anti-IL5 and other similar antibody drugs are effective at reducing asthma exacerbations and reduce the need for oral corticosteroids for those that have severe asthma.
However, some patients respond poorly to Anti-IL5 and the investigators would like to find out why this happens. It is hoped that the investigators can identify the mechanism of poor treatment response to Anti-IL5. It is also hoped that the investigators can understand why symptoms worsen to the point of requiring antibiotics and/or steroids (also known as an exacerbation) for those prescribed Anti-IL5.
- Conditions
- Asthma
- Being tested
- Anti-IL5 Antibody, Bronchoscopy
- Keywords
- Severe Asthma, Anti-IL5, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-IL5 AntibodyDrug
Asthma group: Anti-IL5 treatment Control group: No biologic.
BronchoscopyProcedure or surgery
Optional for both arms
| Study group | Role | What they receive |
|---|---|---|
| Severe asthma | Untreated by anti-IL5 treatment for severe asthma at point of recruitment. To be prescribed anti-IL5 as part of their treatment following consent. Note: Anti-IL5 treatment is prescribed as per agreed multidisciplinary team meeting, outside of the decision to enrol the patient on the study, and is administered by the clinical team as part of the patient's clinical care outside of the research study. Receives: Drug: Anti-IL5 Antibody; Procedure: Bronchoscopy | |
| Healthy control | Control group without respiratory condition Receives: Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of mechanisms associated with poor response to anti-IL5 therapy
Identification of mechanisms associated with poor response to anti-IL5 therapy. A poor response is defined as an inability to halve the pre-treatment annualised exacerbation rate; an asthma exacerbation is defined as a worsening of asthma symptoms necessitating a short burst of oral corticosteroids, or a doubling of maintenance oral corticosteroid treatment dose.
Measured: 12 months
An improvement in FEV1 as assessed by spirometry
Treatment response as assessed as a clinically meaningful improvement in asthma control (ACQ change of >0.5).
Measured: 12 months
A clinically meaningful improvement in asthma control as assessed by ACQ
An improvement in FEV1 of >100ml using spirometry.
Measured: 12 months
Secondary outcomes (2)
The identification of exacerbation pathogenesis in patients receiving anti-IL5 therapy via cytokine analysis
Blood cytokine analysis (analysed by Bio-plex 200 system) will be analysed at ad-hoc exacerbation visits to identify exacerbation pathogenesis.
Measured: 12 months
The identification of exacerbation pathogenesis in patients receiving anti-IL5 therapy via viral throat swab analysis
Viral throat swabs results (using Cepheid Rapid device) will be analysed at ad-hoc exacerbation visits to identify exacerbation pathogenesis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start31 Dec 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114396
- Sponsor's protocol ID
- 18048
- Acronym
- PROCLAIM
- Status last verified
- Nov 2020
- First submitted
- 14 Mar 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Poor Response to Monoclonal Therapy in Asthma
- ClinicalTrials.gov ID
- NCT04114396
- Acronym / sponsor ID
- PROCLAIM / 18048
- Conditions
- Asthma
- Keywords
- Severe Asthma, Anti-IL5, Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma affects 8% of the entire population. 4-5% of asthma sufferers have severe asthma, characterised by recurrent exacerbations (worsening of symptoms leading to the person having a bout of corticosteroids and/or antibiotics), significant symptoms and lack of response to the most widely used therapy, corticosteroids.
There is now new types of treatments (antibody drugs) which are licensed to manage severe asthma such as Anti-IL5. There is evidence Anti-IL5 and other similar antibody drugs are effective at reducing asthma exacerbations and reduce the need for oral corticosteroids for those that have severe asthma.
However, some patients respond poorly to Anti-IL5 and the investigators would like to find out why this happens. It is hoped that the investigators can identify the mechanism of poor treatment response to Anti-IL5. It is also hoped that the investigators can understand why symptoms worsen to the point of requiring antibiotics and/or steroids (also known as an exacerbation) for those prescribed Anti-IL5.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe asthma | – | Drug: Anti-IL5 Antibody, Procedure: BronchoscopyUntreated by anti-IL5 treatment for severe asthma at point of recruitment. To be prescribed anti-IL5 as part of their treatment following consent. Note: Anti-IL5 treatment is prescribed as per agreed multidisciplinary team meeting, outside of the decision to enrol the patient on the study, and is administered by the clinical team as part of the patient's clinical care outside of the research study. |
| Healthy control | – | Procedure: BronchoscopyControl group without respiratory condition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the severe asthma clinic. Once the multidisciplinary team (MDT) have decided that the patient will be prescribed anti-IL5 therapy a patient information sheet (PIS) will be posted out by the clinical team. If the appointment with the clinical team is within days of the MDT, potential participant will be approached by a member of the research team and the study will be discussed and a patient information sheet will be given to the patient. Control participants will be recruited from our Respiratory Research Database and have agreed to be contacted for research. A poster will be created to be put up in Nottingham City Hospital, Queen's Medical Centre and at the University of Nottingham, UK.
Key inclusion criteria (15 listed)
- Aged 18 - 80 years old
- Able to give informed consent
- All patients identified as being suitable for anti-IL5 therapy by the asthma MDT will be considered for study enrolment.
- A measure of compliance with current asthma medication,
- Confirmation of asthma diagnosis
Key exclusion criteria (3 listed)
- Pregnancy
- Pregnancy
- Underlying respiratory conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-IL5 AntibodyAsthma group: Anti-IL5 treatment Control group: No biologic. | Drug | Severe asthma |
| BronchoscopyOptional for both arms | Procedure or surgery | Healthy control, Severe asthma |
Primary outcome
Identification of mechanisms associated with poor response to anti-IL5 therapy
Time frame: 12 months
Identification of mechanisms associated with poor response to anti-IL5 therapy. A poor response is defined as an inability to halve the pre-treatment annualised exacerbation rate; an asthma exacerbation is defined as a worsening of asthma symptoms necessitating a short burst of oral corticosteroids, or a doubling of maintenance oral corticosteroid treatment dose.
An improvement in FEV1 as assessed by spirometry
Time frame: 12 months
Treatment response as assessed as a clinically meaningful improvement in asthma control (ACQ change of >0.5).
A clinically meaningful improvement in asthma control as assessed by ACQ
Time frame: 12 months
An improvement in FEV1 of >100ml using spirometry.
2 secondary outcomes
The identification of exacerbation pathogenesis in patients receiving anti-IL5 therapy via cytokine analysis
Time frame: 12 months
The identification of exacerbation pathogenesis in patients receiving anti-IL5 therapy via viral throat swab analysis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
Related trials for Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
RecruitingObservational study
Swiss Severe Asthma Register
Severe Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of Nottingham at 1 site in United Kingdom.
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 15 inclusion and 3 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yik L Pang, BMedSci, MBBS, MRCP (01158231702, mszyp@exmail.nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of mechanisms associated with poor response to anti-IL5 therapy (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020.