Actively Recruiting

Age: 18Years +
All Genders
NCT07189806

Longitudinal Phenotyping and Endotyping Study in Adult Patients With Mild, Moderate, or Severe Asthma

Led by Hvivo · Updated on 2025-09-24

250

Participants Needed

1

Research Sites

1304 weeks

Total Duration

On this page

Sponsors

H

Hvivo

Lead Sponsor

K

King's College London

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Longitudinal Phenotyping and Endotyping Study in Adult Patients With Mild, Moderate, or Severe Asthma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 site clinics with a clinical diagnosis of asthma
  • Positive response to methacholine challenge test, or
  • Positive response to bronchodilator responsiveness test, or
  • Peak Flow variability greater than 20%, or
  • Documented FEV1 improvement of 12% and 200 mL after maintenance anti-asthma treatment, or
  • Physician diagnosis of current asthma
  • Ability to follow study requirements as judged by investigator
Not Eligible

You will not qualify if you...

  • Patients not attending hVIVO respiratory site clinics
  • Primary respiratory diagnosis other than asthma (co-diagnosis with other respiratory diseases allowed)
  • Females who are breastfeeding
  • Females with a positive pregnancy test at screening
  • Patients unlikely to complete 5 years of follow-up due to factors like poor literacy, substance abuse, or life-threatening comorbidities
  • Contraindications for lung function testing including hemoptysis of unknown origin, pulmonary hypertension, previous pneumothorax, unstable cardiovascular status, aneurysms, recent eye or thoracic/abdominal surgery
  • Patients with lifetime history of anaphylaxis or severe allergic reaction

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

hVIVO Services Limited, 40 Bank Street

London, United Kingdom, E14 5NR

Actively Recruiting

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Research Team

A

Alex Mann

CONTACT

A

Alexandre Lima, MD-PhD

CONTACT

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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Longitudinal Phenotyping and Endotyping Study in Adult Patients With Mild, Moderate, or Severe Asthma | DecenTrialz