Recruiting

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

ClinicalTrials.gov IDNCT07189806

PhaseNot Applicable

Enrollment250

SponsorHvivo

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Asthma (Diagnosis)

About this study

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…

Primary outcomes

Exacerbation history (number and severity) (Baseline, Year 1, 2, 3, 4, 5)
Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L]) (Change from baseline FEV1 at Year 1, 2, 3, 4, 5)
Spirometry - change in Forced Vital Capacity (FVC) (L) (Change from baseline FVC at Year 1, 2, 3, 4, 5)
Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s]) (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) (Change from baseline FEF25-75% at Year 1, 2, 3, 4, 5)
Post-bronchodilator spirometry - FEV1 (L) (Optionally Year 1,2,3,4,5)
Post-bronchodilator spirometry - FVC (L) (Time Frame: Optionally Year 1,2,3,4,5)
Post-bronchodilator spirometry - PEF (L/s) (Optionally Year 1,2,3,4,5)

Eligibility information

Inclusion Criteria: 1. Male or Female patients aged ≥ 18 years and older who have signed an Informed Consent form. 2. 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. 3. In the PI/investigator(s) opinion, will be able to follow the study requirements. Exclusion Criteria: 1. Asthma patients who are not attending hVIVO respiratory site clinics. 2. 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) 3. Females who: 1. Are breastfeeding, or 2. Have a positive pregnancy test at any point during screening 4. 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. 5. 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. 6. Patients with lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction

Study locations

hVIVO Services Limited, 40 Bank Street, London, E14 5NR United Kingdom

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.