Actively Recruiting
A Study of Mild, Moderate and Severe Asthma Characterising Phenotypes and Endotypes and Their Long-Term Associations with Exacerbations and Disease Progression
Led by Hvivo · Updated on 2025-09-24
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hvivo
Lead Sponsor
K
King's College London
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how asthma varies among adults aged 18 and older, aiming to understand different asthma types and monitor changes over time. The study focuses on causes and triggers of asthma flare-ups, symptoms, airway inflammation, and how these factors influence respiratory health. This long-term observational study will help improve knowledge of asthma progression and outcomes by gathering detailed information from patients with mild to severe asthma. Participants will attend an initial screening visit to confirm eligibility and assess their asthma. This is followed by about five annual clinic visits and periodic phone follow-ups. Between annual visits, participants will perform self-assessments at home every six months and when experiencing cold-like symptoms. At home, participants will collect nasal and throat swabs and complete symptom, medication, and lung function diaries. The study may also include optional sub-studies involving additional tests and challenges. During the clinic visits, researchers will perform assessments such as spirometry, lung function tests, blood and respiratory sample collection, allergy skin prick tests, and questionnaires about asthma control and quality of life. Participants will be monitored for any side effects from tests like the methacholine challenge. Data collected will measure asthma exacerbation frequency and severity, lung function changes, inflammation markers, and symptom control over at least five years. Participants may withdraw at any time, and abnormal findings will be shared with them and their healthcare providers.
CONDITIONS
Brief Title
Longitudinal Phenotyping and Endotyping Study in Adult Patients With Mild, Moderate, or Severe Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older who have signed an informed consent form
- Patients attending hVIVO respiratory clinics with a clinical diagnosis of asthma
- Positive response to methacholine challenge test, bronchodilator responsiveness test, or peak flow variability over 20%
- Documented improvement in lung function after regular asthma treatment or physician diagnosis of current asthma
- Ability to follow study requirements as judged by the investigator
You will not qualify if you...
- Asthma patients not attending hVIVO respiratory clinics
- Primary respiratory diagnosis other than asthma (co-diagnosis allowed)
- Females who are breastfeeding or have a positive pregnancy test during screening
- Patients unlikely to complete 5 years of follow-up due to literacy, substance abuse, or life-threatening conditions
- Contraindications for lung function testing such as hemoptysis, pulmonary hypertension, pneumothorax, unstable cardiovascular status, aneurysms, recent eye or thoracic surgery
- History of anaphylaxis or severe allergic reactions in lifetime
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 5 years
Participants are observed with yearly clinic visits and intermittent at-home self-monitoring to assess asthma progression, symptoms, and biomarkers.
Yearly clinic visits and home self-assessments every 6 months and during respiratory symptoms
Trial Site Locations
Total: 1 location
1
hVIVO Services Limited, 40 Bank Street
London, United Kingdom, E14 5NR
Actively Recruiting
Research Team
A
Alex Mann
A
Alexandre Lima, MD-PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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