Long-term tracking and profiling of adults with mild to severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational registry enrolling adults (≥18) with clinician-diagnosed asthma at the hVIVO respiratory site, including a wide spectrum of severity and Type 2 high and low participants. Participants have a baseline clinic visit and are expected to attend about five annual clinic visits with interim at-home self-monitoring roughly halfway between visits, with follow-up calls as needed. Data collected will include clinical measures, respiratory and blood biomarkers, exacerbation history, and trigger/exposure information to characterize variability, stability, and progression of disease. The registry is open-ended with an initial cohort target of at least 235 participants and plans for monitoring longer-term outcomes for at least five years.

Why it matters

Who can join: the full rules

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

Where it's running

• hVIVO Services Limited, 40 Bank Street
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Alexandre Lima, MD-PhD — Hvivo
• Study coordinator: Alex Mann
• Email: projectadmin@hvivo.com
• Phone: +44 (0)207 756 1300

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• IOS-based platform to screen, diagnose, and manage COPD and asthma

  This study tests an Impulse Oscillometry system to screen for and diagnose COPD and asthma and to help predict flare-ups over about a year, involving adults in China.

  Recruiting Beijing Chao Yang Hospital · Beijing, Beijing Municipality · NCT07910409

• REACH: Resources and Education to Help Kids with Asthma in School

  A service model called REACH will try to improve school-based asthma care by coordinating care between healthcare, school, and home for children with asthma.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT07819747

• Beclometasone Dipropionate and Formoterol inhalation combo vs FOSTER in adults with asthma

  This Phase 3 trial tests whether a beclometasone formoterol inhalation combo works as well or better than FOSTER for adults with asthma.

  Recruiting Phase 3 Lunan Better Pharmaceutical Co., LTD. · Shanghai, Shanghai Municipality · NCT07768891

• Test of SKB575 in adults with asthma

  This study tests whether SKB575 helps people with asthma compared to a placebo.

  Recruiting at 2 sites Phase 1 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Chengdu, Sichuan and 1 other locations · NCT07732023

• KT-621 long-term safety and efficacy in asthma patients previously in KT-621 study

  This phase 2b study tests KT-621 in people with asthma who finished a prior KT-621 study to see if long-term treatment is safe and helpful.

  Recruiting at 7 sites Phase 2 Kymera Therapeutics, Inc. · Miami, Florida and 6 other locations · NCT07677059

• Dog-allergy immunotherapy with Alutard SQ Dog in Swedish practice

  This study tests whether Alutard SQ Dog immunotherapy helps adults with moderate-to-severe dog allergy when used in real-world Swedish care.

  Recruiting at 2 sites Phase 4 Karolinska Institutet · Lund, Skåne County and 1 other locations · NCT07651891

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.