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

NCT07189806 | Recruiting

• 1 other identifier: HRD-AST-001
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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 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

Asthma (Diagnosis)

Keywords

Asthma; Severe; Moderate; Mild; Exacerbations; Longitudinal; Observational; Dyspnea; coughing; Inflammation; Bronchospasm

Outcome Measures

Primary Outcomes (21)

• Exacerbation history (number and severity)

  Medical review

  Baseline, Year 1, 2, 3, 4, 5

• Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L])

  Lung function test

  Change from baseline FEV1 at Year 1, 2, 3, 4, 5

• Spirometry - change in Forced Vital Capacity (FVC) (L)

  Lung function test

  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

  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

  Change from baseline FEF25-75% at Year 1, 2, 3, 4, 5

• Post-bronchodilator spirometry - FEV1 (L)

  Bronchodilator responsiveness test

  Optionally Year 1,2,3,4,5

• Post-bronchodilator spirometry - FVC (L)

  Bronchodilator responsiveness test

  Time Frame: Optionally Year 1,2,3,4,5

• Post-bronchodilator spirometry - PEF (L/s)

  Bronchodilator responsiveness test

  Optionally Year 1,2,3,4,5

• Post-bronchodilator spirometry - FEF25-75% (L/s)

  Bronchodilator responsiveness test

  Optionally Year 1,2,3,4,5

• Oscillometry - Absolute and change in R5-R20 kPa/L

  Small airway test

  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

  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

  Grouping, absolute and Change from baseline X5 at Year 1, 2, 3, 4, 5

• Skin Prick Test - Qualitative atopy

  Atopy Test

  Baseline, & optionally Year 1,2,3,4,5

• Methacholine Test - provocative concentration (PC20) causing a 20% fall in (FEV1) (mg/mL)

  Airway Hyperreactivity Test

  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

  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

  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

  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

  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

  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

  Baseline and Change from baseline scores at Year 1, 2, 3, 4, 5, & ad-hoc timepoints

• Patient reported cold perception

  Patient reported outcome questionnaire

  Baseline and Year 1, 2, 3, 4, 5, & ad-hoc timepoints

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who attend the hVIVO respiratory site clinics who have a clinical diagnosis and meet the inclusion criteria for the study.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvivo: lead
• King's College London: collaborator

Study Sites (1)

hVIVO Services Limited, 40 Bank Street

London, E14 5NR, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood/Serum, Urine and Nasal samples: Some samples or portions of samples collected from participants may remain after the study is completed. Additionally, with written informed consent, extra optional blood samples may be collected. These leftover and/or additional samples and the clinical and research information that accompanies them may be useful for future research projects. If the participants consents, these remaining samples will become part of a collection to be stored at hVIVO's nominated laboratory.

MeSH Terms

Conditions

Asthma; Disease; Lymphoma, Follicular; Dyspnea; Cough; Inflammation; Bronchial Spasm

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Alexandre Lima, MD-PhD

  Hvivo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Mann

CONTACT

+44 (0)207 756 1300; projectadmin@hvivo.com

Alexandre Lima, MD-PhD

CONTACT

+44 (0)207 756 1300; projectadmin@hvivo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 24, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): August 8, 2050
• Study Completion (Estimated): August 8, 2050
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)