A Study of Mild, Moderate and Severe Asthma: Characterisation of Phenotypes and Endotypes and Longitudinal Associations With Exacerbations, Triggers and Disease Progression (MAPLE-UK)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hvivo
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Exacerbation history (number and severity)
研究概览
简要总结
Background and study aims:
The purpose of this research registry is to understand how asthma varies from person to person and monitor changes that may occur over time.
The effects that asthma has on the body will be assessed, by looking at different causes/triggers of flare-ups/exacerbations, asthma symptoms, and how inflammation of the airways may affect respiratory health over time.
The information obtained from this study will allow hVIVO to better understand respiratory disease progression and outcomes in asthma patients.
Who can participate:
Male or Female patients aged ≥ 18 years who are attending the hVIVO respiratory site clinics and have a clinical diagnosis of asthma.
What does the study involve:
The study will consist of a baseline clinic visit to confirm suitability and assess participants' asthma followed by approximately 5 annual clinic visits and follow-up phone calls, as necessary. Intermediate home self-assessments will also be scheduled for halfway between each annual clinic visit. Upon experiencing cold-like symptoms, participants will be asked to complete a at home self-nasal and throat swab as well as symptom, medication, and lung function home diary cards.
What are the possible benefits and risks of participating:
Taking part will not improve participants' health, although participants might benefit from a general health check at Screening as well as additional health checks and assessments of participants' inhaler technique during the conduct of the study.
There may be unexpected and unforeseen risks related to the study procedures. When attending for clinic visits, assessment will be performed by appropriately trained and qualified staff. Participants will be monitored for any procedure related symptoms such as, pain or bruising at the site where blood is drawn. Discomfort, sneezing, watery eyes, irritated nose, or nose bleeding during nasal sample collection. Light-headedness, dizziness, fatigue, coughing, shortness of breath, headaches, chest discomfort, throat irritation and itching during lung function testing. Skin irritation and allergic reactions from skin prick testing.
Should participants experience any of these symptoms, trained staff will be on hand to provide the appropriate medical treatment.
The Methacholine bronchial challenge test is also likely to cause asthma symptoms such as wheezing, shortness of breath, and chest tightness. In rare cases, the test can cause severe bronchospasm.
After the test or if the bronchospasm is severe, the technician will give the participant medication to inhale that will open the airways.
If the participant experiences any asthma exacerbation as a result of the methacholine test, the exacerbation management guidelines will be used to assess the participant and guide treatment.
Only participants that are not contraindicated for a methacholine test will have this performed.
For the at home assessments, participants will receive proper training on how to perform these during screening visit and as needed during each clinic follow-up visit.
Any abnormalities identified during the study will be communicated to the participant, as well as to the participant's GP or a specialist if necessary.
Where is the study run from:
hVIVO Services Limited - UK. Please see Participating Centres listed above for address.
When is the study starting and how long is it expected to run for:
The study began enrolling participants from 08th August 2025 and is unending, with an initial cohort of 235 expected to last approximately 5 years for each participant.
Who is funding the study:
hVIVO Services Limited
Who is the main contact:
Alex Mann - projectadmin@hvivo.com
详细描述
The MAPLE study is a prospective observational study of asthma patients at the hVIVO clinical site. This study is designed as a long-term research vehicle with no limit to enrolment or any time defined end.
The MAPLE study will enrol from across the spectrum of asthma severity and specifically include a strong representation of mild asthma, it will also include well controlled and less controlled, Type 2 high and low participants. Key aims will focus on the risk of progression and influence of various triggers, frequency of clinical and inflammatory risk factors (as and when participants progress from mild to more severe asthma), and assess variability and stability of respiratory and blood biomarkers and their ability to inform and predict risk (including inflammatory biomarkers, and blood cells).
An initial cohort of up to at least 235 asthma patients, ≥18 years of age who attend hVIVO's clinical site, are planned to be enrolled. Longer-term clinical outcomes will be monitored for at least 5 years.
Data will be collected both at yearly clinic visits as well as at planned intermediate at-home self-monitoring intervals.
The study design is divided into the following study phases:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female patients aged ≥ 18 years and older who have signed an Informed Consent form.
- •All patients who attend the hVIVO respiratory site clinics who have a clinical diagnosis of asthma/any of the following:
- •Positive response to methacholine challenge test (AHR), or
- •Positive response to a bronchodilator responsiveness test, or
- •Peak Flow variability (i.e. highest - lowest PEF over the day/mean value of the two, × 100) > 20%, or
- •Documented response (defined as ΔFEV1 ≥ 12% and ≥ 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment, or
- •physician diagnosis of current asthma.
- •In the PI/investigator(s) opinion, will be able to follow the study requirements.
排除标准
- •Asthma patients who are not attending hVIVO respiratory site clinics.
- •Patients whose primary respiratory diagnosis (i.e. the condition causing most of their respiratory symptoms) is not asthma (however, a co-diagnosis of another respiratory disease such as COPD, bronchiectasis or interstitial lung disease together with asthma will be accepted)
- •Females who:
- •Are breastfeeding, or
- •Have a positive pregnancy test at any point during screening
- •Patients who, in the opinion of the physician, are unlikely to complete the 5 years of follow-up, e.g. poor literacy, substance abuse, life threatening comorbidities.
- •Contraindications for lung function testing, e.g., hemoptysis of unknown origin, history of pulmonary hypertension, previous pneumothorax, unstable cardiovascular status (severe heart failure, or ischemic heart disease), aneurysms (thoracic, abdominal or cerebral), recent eye surgery (e.g., cataract), recent thoracic or abdominal surgery.
- •Patients with lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction
结局指标
主要结局
Exacerbation history (number and severity)
时间窗: Baseline, Year 1, 2, 3, 4, 5
Medical review
Methacholine Test - provocative concentration (PC20) causing a 20% fall in (FEV1) (mg/mL)
时间窗: Baseline, & optionally Year 1,2,3,4,5
Airway Hyperreactivity Test
Absolute and change from baseline symptoms/symptom control assessed by the Asthma Impairment and Risk Questionnaire (AIRQ®)
时间窗: Baseline and Change from baseline AIRQ scores at Year 1, 2, 3, 4, 5
Patient reported outcome questionnaire
Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L])
时间窗: Change from baseline FEV1 at Year 1, 2, 3, 4, 5
Lung function test
Spirometry - change in Forced Vital Capacity (FVC) (L)
时间窗: Change from baseline FVC at Year 1, 2, 3, 4, 5
Lung function test
Post-bronchodilator spirometry - FEV1 (L)
时间窗: Optionally Year 1,2,3,4,5
Bronchodilator responsiveness test
Oscillometry - Absolute and change in X5 kPa/L
时间窗: Grouping, absolute and Change from baseline X5 at Year 1, 2, 3, 4, 5
Small Airway Test
Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s])
时间窗: Change from baseline PEF at Year 1, 2, 3, 4, 5
Lung function test
Spirometry - change in Forced Expiratory Flow at 25-75% of the forced vital capacity (FEF25-75%) (L/s)
时间窗: Change from baseline FEF25-75% at Year 1, 2, 3, 4, 5
Lung function test
Post-bronchodilator spirometry - FVC (L)
时间窗: Time Frame: Optionally Year 1,2,3,4,5
Bronchodilator responsiveness test
Post-bronchodilator spirometry - PEF (L/s)
时间窗: Optionally Year 1,2,3,4,5
Bronchodilator responsiveness test
Post-bronchodilator spirometry - FEF25-75% (L/s)
时间窗: Optionally Year 1,2,3,4,5
Bronchodilator responsiveness test
Oscillometry - Absolute and change in R5-R20 kPa/L
时间窗: Grouping, absolute and Change from baseline R5-R20 at Year 1, 2, 3, 4, 5
Small airway test
Oscillometry - Absolute and change in AX kPa/L
时间窗: Grouping, absolute and Change from baseline AX at Year 1, 2, 3, 4, 5
Small Airway Test
Skin Prick Test - Qualitative atopy
时间窗: Baseline, & optionally Year 1,2,3,4,5
Atopy Test
Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb])
时间窗: Baseline, & Year 1,2,3,4,5
Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath
Absolute and change from baseline symptoms/symptom control assessed by the Asthma Control Questionnaire (ACQ®)
时间窗: Baseline and Change from baseline ACQ mean scores at Year 1, 2, 3, 4, 5, & ad-hoc timepoints
Patient reported outcome questionnaire
Absolute and change from baseline symptoms/symptom control assessed by the Asthma Quality of Life Questionnaire (AQLQ®)
时间窗: Baseline and Change from baseline AQLQ scores optionally at Year 1, 2, 3, 4, 5
Patient reported outcome questionnaire
Absolute and change from baseline symptoms assessed by self-reported ordinal scale diary card
时间窗: Baseline and Change from baseline scores at Year 1, 2, 3, 4, 5, & ad-hoc timepoints
Patient reported outcome questionnaire
Absolute and change from baseline symptoms assessed by self-reported visual analogue scale diary card
时间窗: Baseline and Change from baseline scores at Year 1, 2, 3, 4, 5, & ad-hoc timepoints
Patient reported outcome questionnaire
Patient reported cold perception
时间窗: Baseline and Year 1, 2, 3, 4, 5, & ad-hoc timepoints
Patient reported outcome questionnaire
次要结局
未报告次要终点