An observational study in Asthma (Diagnosis), sponsored by Hvivo. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Hvivo · Observational
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
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:
Baseline: Participants who have shown an interest in hVIVO will be invited to a screening visit, where where details of the study will be provided. Historical generic screening data collected through the hVIVO generic screening process may be transferred to this study after the study-specific consent form has been signed by the participant.
Study Specific Informed consent: Volunteers deemed ineligible by the Investigator during the consenting consultation will be excluded and will not proceed. If eligible, the volunteer will continue to have the following assessments and procedures performed but, may be excluded at any point should any of the procedures listed below immediately demonstrate ineligibility.
For participants enrolled in to Optional Sub-studies, the following additional assessments may be performed at the screening visit and at any time on and between annual clinic visits and may occur once or more for consented participants throughout the study.
Participants will attend yearly clinic follow-up visits and will be required to complete at home self-assessments at 6 monthly intervals and when experiencing symptoms of a respiratory infection.
During each yearly clinic visit, procedures similar to the baseline visit will be performed as appropriate to reassess change in participants' asthma and medications.
Interim at home assessments will include:
Home Participants Diary Card that includes assessments of:
Participants may withdraw from the study at any time, and all efforts will be made to document any reasons for withdrawal and to complete required end-of-study assessments.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 250 is above the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →Hvivo is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who attend the hVIVO respiratory site clinics who have a clinical diagnosis and meet the inclusion criteria for the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All patients who attend the hVIVO respiratory site clinics who have a clinical diagnosis of asthma/any of the following:
Exclusion Criteria:
Females who:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Exacerbation history (number and severity)
Medical review
Time frame: Baseline, Year 1, 2, 3, 4, 5
Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L])
Lung function test
Time frame: Change from baseline FEV1 at Year 1, 2, 3, 4, 5
Spirometry - change in Forced Vital Capacity (FVC) (L)
Lung function test
Time frame: Change from baseline FVC at Year 1, 2, 3, 4, 5
Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s])
Lung function test
Time frame: Change from baseline PEF at Year 1, 2, 3, 4, 5
Spirometry - change in Forced Expiratory Flow at 25-75% of the forced vital capacity (FEF25-75%) (L/s)
Lung function test
Time frame: Change from baseline FEF25-75% at Year 1, 2, 3, 4, 5
Post-bronchodilator spirometry - FEV1 (L)
Bronchodilator responsiveness test
Time frame: Optionally Year 1,2,3,4,5
Post-bronchodilator spirometry - FVC (L)
Bronchodilator responsiveness test
Time frame: Time Frame: Optionally Year 1,2,3,4,5
Post-bronchodilator spirometry - PEF (L/s)
Bronchodilator responsiveness test
Time frame: Optionally Year 1,2,3,4,5
Post-bronchodilator spirometry - FEF25-75% (L/s)
Bronchodilator responsiveness test
Time frame: Optionally Year 1,2,3,4,5
Oscillometry - Absolute and change in R5-R20 kPa/L
Small airway test
Time frame: Grouping, absolute and Change from baseline R5-R20 at Year 1, 2, 3, 4, 5
Oscillometry - Absolute and change in AX kPa/L
Small Airway Test
Time frame: Grouping, absolute and Change from baseline AX at Year 1, 2, 3, 4, 5
Oscillometry - Absolute and change in X5 kPa/L
Small Airway Test
Time frame: Grouping, absolute and Change from baseline X5 at Year 1, 2, 3, 4, 5
Skin Prick Test - Qualitative atopy
Atopy Test
Time frame: Baseline, & optionally Year 1,2,3,4,5
Methacholine Test - provocative concentration (PC20) causing a 20% fall in (FEV1) (mg/mL)
Airway Hyperreactivity Test
Time frame: Baseline, & optionally Year 1,2,3,4,5
Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb])
Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath
Time frame: Baseline, & Year 1,2,3,4,5
Absolute and change from baseline symptoms/symptom control assessed by the Asthma Control Questionnaire (ACQ®)
Patient reported outcome questionnaire
Time frame: Baseline and Change from baseline ACQ mean scores at Year 1, 2, 3, 4, 5, & ad-hoc timepoints
Absolute and change from baseline symptoms/symptom control assessed by the Asthma Impairment and Risk Questionnaire (AIRQ®)
Patient reported outcome questionnaire
Time frame: Baseline and Change from baseline AIRQ scores at Year 1, 2, 3, 4, 5
Absolute and change from baseline symptoms/symptom control assessed by the Asthma Quality of Life Questionnaire (AQLQ®)
Patient reported outcome questionnaire
Time frame: Baseline and Change from baseline AQLQ scores optionally at Year 1, 2, 3, 4, 5
Absolute and change from baseline symptoms assessed by self-reported ordinal scale diary card
Patient reported outcome questionnaire
Time frame: Baseline and Change from baseline scores at Year 1, 2, 3, 4, 5, & ad-hoc timepoints
Absolute and change from baseline symptoms assessed by self-reported visual analogue scale diary card
Patient reported outcome questionnaire
Time frame: Baseline and Change from baseline scores at Year 1, 2, 3, 4, 5, & ad-hoc timepoints
Patient reported cold perception
Patient reported outcome questionnaire
Time frame: Baseline and Year 1, 2, 3, 4, 5, & ad-hoc timepoints
Plan to share: No
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