AsthmaNCT04650503
Follow-up of Mild Eosinophilic Asthma
An observational study of Asthma, run by Laval University at 1 site in Canada.
Trial summary
Asthma is a chronic respiratory disease affecting approximately 10% of the population, the majority of patients with very mild to mild asthma. Asthma is characterized primarily by the presence of symptoms clinical variables, reversible airway obstruction and airway hyperresponsiveness. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Asthma
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2019to Dec 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthmatic subjects with at least two sputum cell differential results > 1 year before follow-up visit
Who may be able to join
- With a proven diagnosis of asthma
- With very mild or mild asthma at the time of previous assessment
- With at least two sputum cell differential counts > 1 year before follow-up visit
- With stable asthma and asthma medication for at least 4 weeks before baseline assessment and before follow-up visit
- Able and willing to consent to study procedures
Who cannot join
- Conditions that could affect measurements, such as any active chronic or systemic inflammatory disease, not related to the respiratory system.
- Subjects with a main diagnosis of eosinophilic granulomatosis with polyangiitis (Churg- Strauss syndrome) or hypereosinophilic syndrome.
- Respiratory tract infection in the 4 weeks preceding past assessments and in the 4 weeks preceding follow-up visit.
- Asthma exacerbation in the 4 weeks preceding past assessments in the 4 weeks preceding follow-up visit.
- Current smokers. Ex-smokers must not have smoked for a minimum of 12 months, and should not have a smoking history ≥10 pack years. Subjects who administer nicotine in other forms (patches, chew tobacco, electronic cigarettes, etc.) will also be excluded from the study;
- Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease.
- Pregnant or lactating women at the time of follow-up visit.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Louis-Philippe Boulet
Québec, G1V4G5
Louis-Philippe Boulet, MD, 4186564747, lpboulet@med.ulaval.ca
Marie-Eve Boulay, MSc, 4186568711 ext. 2617, marie-eve.boulay@criucpq.ulaval.ca
About this study
Official title: Clinical Outcome of Mild to Very-mild Asthma With High Sputum Eosinophils and/or High Genetic Risk Score: a Prospective Longitudinal Study
Asthma is a chronic respiratory disease affecting approximately 10% of the population, the majority of patients with very mild to mild asthma. Asthma is characterized primarily by the presence of symptoms clinical variables, reversible airway obstruction and airway hyperresponsiveness. Inflammation is a key factor in the pathophysiology of the disease. Eosinophilic inflammation is the most common type. However, in the literature it is usually associated with more severe and difficult to control asthma. Although mortality associated with asthma has drastically decreased in recent years, several events still occur. Strangely enough, these frequently affect mild asthmatics. Although there is still a misunderstanding in relation to these events, the most recent practice guides have recommended an approach based on the use of inhaled corticosteroids (ICS) in all, including mild asthmatics. This change of therapeutic cap is still debated, but indicates a need for new studies in this population. Recently, the investigators demonstrated that a subgroup of asthma patients with mild asthma had a eosinophilia. The evolution of this subgroup without bronchial obstruction or respiratory symptoms remains unknown. Indeed, it seems imperative to determine the fate of these subjects in comparison with asthma mild non-eosinophilic since it could be a subgroup at risk of poor outcome. The objective of this study will be to examine the course of asthma in very mild to mild asthma patients who exhibit eosinophilic inflammation of the respiratory tract compared to noneosinophilic subjects.
This will be a prospective observational, longitudinal study. Participants for whom a result of induced sputum showing an eosinophil level greater than or equal to 3% was observed at least 1 year ago will be contacted to participate in the study. They will be matched for age, gender and duration of asthma to subjects without eosinophilia. These subjects will not be on bronchial anti-inflammatory medication. They will have a complete evaluation including respiratory function tests, a methacholine challenge and sputum induction. They will also complete questionnaires on controlling their asthma and exacerbations.
- Conditions
- Asthma
- Being tested
- No intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with eosinophilic asthma at baseline | Patients showing ≥3% sputum eosinophils at baseline Receives: Other: No intervention | |
| Patients with non eosinophilic asthma at baseline | Patients showing <3% sputum eosinophils at baseline Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean annual change in pre bronchodilator forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FVC) between baseline and follow-up between the two groups
calculated using: (initial value - follow-up value)/number of years between the two tests
Measured: At least one year post baseline
Secondary outcomes (6)
Clinical sub score of the Asthma Control Scoring system (ACSS) at follow-up between the two groups
Score between 20% and 100%
Measured: At least one year post baseline
Number of asthma exacerbations in the year preceding follow-up visit between the two groups
Asthma exacerbations defined as a) number of emergency room visits, b) number of hospitalisations, c) number of oral corticosteroid treatments, and d) number of unscheduled medical visits
Measured: At least one year post baseline
Airway reactivity at follow-up between the two groups
Airway reactivity recorded as methacholine provocative concentration inducing a 20% fall in forced expiratory volume in one second (FEV1) (PC20)
Measured: At least one year post baseline
Prescribed therapy at follow-up between the two groups
Defined as a) daily dose of inhaled corticosteroids (ICS), b) use of second controller therapy
Measured: At least one year post baseline
Airway inflammation between the two groups at follow-up
Percentage of sputum eosinophils
Measured: At least one year post baseline
Systemic inflammation between the two groups at follow-up
Blood levels of eosinophils (X10^9/ml)
Measured: At least one year post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Aug 2019
- Primary completionSep 2021 (estimated)
- Study completionDec 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 Laval UniversityThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Louis-Philippe Boulet, MD, Principal investigator, IUCPQ-UL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650503
- Sponsor's protocol ID
- CÉR21799
- Status last verified
- Dec 2020
- First submitted
- 14 Oct 2020
- Last updated
- 2 Dec 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 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Mild to Very-mild Asthma With High Sputum Eosinophils and/or High Genetic Risk Score: a Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT04650503
- Acronym / sponsor ID
- CÉR21799
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 2 Dec 2020 (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 is a chronic respiratory disease affecting approximately 10% of the population, the majority of patients with very mild to mild asthma. Asthma is characterized primarily by the presence of symptoms clinical variables, reversible airway obstruction and airway hyperresponsiveness. Inflammation is a key factor in the pathophysiology of the disease. Eosinophilic inflammation is the most common type. However, in the literature it is usually associated with more severe and difficult to control asthma. Although mortality associated with asthma has drastically decreased in recent years, several events still occur. Strangely enough, these frequently affect mild asthmatics. Although there is still a misunderstanding in relation to these events, the most recent practice guides have recommended an approach based on the use of inhaled corticosteroids (ICS) in all, including mild asthmatics. This change of therapeutic cap is still debated, but indicates a need for new studies in this population. Recently, the investigators demonstrated that a subgroup of asthma patients with mild asthma had a eosinophilia. The evolution of this subgroup without bronchial obstruction or respiratory symptoms remains unknown. Indeed, it seems imperative to determine the fate of these subjects in comparison with asthma mild non-eosinophilic since it could be a subgroup at risk of poor outcome. The objective of this study will be to examine the course of asthma in very mild to mild asthma patients who exhibit eosinophilic inflammation of the respiratory tract compared to noneosinophilic subjects.
This will be a prospective observational, longitudinal study. Participants for whom a result of induced sputum showing an eosinophil level greater than or equal to 3% was observed at least 1 year ago will be contacted to participate in the study. They will be matched for age, gender and duration of asthma to subjects without eosinophilia. These subjects will not be on bronchial anti-inflammatory medication. They will have a complete evaluation including respiratory function tests, a methacholine challenge and sputum induction. They will also complete questionnaires on controlling their asthma and exacerbations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with eosinophilic asthma at baseline | – | Other: No interventionPatients showing ≥3% sputum eosinophils at baseline |
| Patients with non eosinophilic asthma at baseline | – | Other: No interventionPatients showing <3% sputum eosinophils at baseline |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthmatic subjects with at least two sputum cell differential results > 1 year before follow-up visit
Key inclusion criteria (5 listed)
- With a proven diagnosis of asthma
- With very mild or mild asthma at the time of previous assessment
- With at least two sputum cell differential counts > 1 year before follow-up visit
- With stable asthma and asthma medication for at least 4 weeks before baseline assessment and before follow-up visit
- Able and willing to consent to study procedures
Key exclusion criteria (7 listed)
- Conditions that could affect measurements, such as any active chronic or systemic inflammatory disease, not related to the respiratory system.
- Subjects with a main diagnosis of eosinophilic granulomatosis with polyangiitis (Churg- Strauss syndrome) or hypereosinophilic syndrome.
- Respiratory tract infection in the 4 weeks preceding past assessments and in the 4 weeks preceding follow-up visit.
- Asthma exacerbation in the 4 weeks preceding past assessments in the 4 weeks preceding follow-up visit.
- Current smokers. Ex-smokers must not have smoked for a minimum of 12 months, and should not have a smoking history ≥10 pack years. Subjects who administer nicotine in other forms (patches, chew tobacco, electronic cigarettes, etc.) will also be excluded from the study;
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 |
|---|---|---|
| No interventionNo intervention | Other | Patients with eosinophilic asthma at baseline, Patients with non eosinophilic asthma at baseline |
Primary outcome
Mean annual change in pre bronchodilator forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FVC) between baseline and follow-up between the two groups
Time frame: At least one year post baseline
calculated using: (initial value - follow-up value)/number of years between the two tests
6 secondary outcomes
Clinical sub score of the Asthma Control Scoring system (ACSS) at follow-up between the two groups
Time frame: At least one year post baseline
Number of asthma exacerbations in the year preceding follow-up visit between the two groups
Time frame: At least one year post baseline
Airway reactivity at follow-up between the two groups
Time frame: At least one year post baseline
Prescribed therapy at follow-up between the two groups
Time frame: At least one year post baseline
Airway inflammation between the two groups at follow-up
Time frame: At least one year post baseline
Systemic inflammation between the two groups at follow-up
Time frame: At least one year post baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
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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.
Louis-Philippe Boulet, MD principal investigator
IUCPQ-UL
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 Laval University at 1 site in Canada.
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 5 inclusion and 7 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 2 Dec 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 Canada. 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 Louis-Philippe Boulet, MD (4186564747, lpboulet@med.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean annual change in pre bronchodilator forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FVC) between baseline and follow-up between the two groups (time frame: At least one year post baseline). 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 2 Dec 2020.