Status:
RECRUITING
Longitudinal Phenotyping and Endotyping Study in Adult Patients With Mild, Moderate, or Severe Asthma
Lead Sponsor:
Hvivo
Collaborating Sponsors:
King's College London
Conditions:
Asthma (Diagnosis)
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
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 define...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 8 2050
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT07189806
Start Date
August 8 2025
End Date
August 8 2050
Last Update
September 24 2025
Active Locations (1)
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1
hVIVO Services Limited, 40 Bank Street
London, United Kingdom, E14 5NR