AzTrials
AzTrials

AsthmaNCT06811740

Treatable Traits of Severe Asthma

A study testing Individualized cluster management and Routine asthma treatment in people with Asthma, run by Beijing Chao Yang Hospital at 3 sites in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Severe or uncontrolled asthma is a complex heterogeneous disease, in which patients may exhibit different types of airway inflammation and often accompany multiple comorbidities and risk factors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Individualized cluster management and Routine asthma treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
3 sitesChina
Study dates
1 Jan 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be at least 18 years old and have resided in Beijing for at least 6 months.
  • Must meet the diagnostic criteria for asthma as outlined in the 2023 GINA guidelines, have written evidence of variable airflow limitation, and have been receiving asthma treatment for at least 6 months.
  • Must meet one or both of the following criteria as defined in the 2023 GINA guidelines for uncontrolled asthma: poor symptom control (defined as an Asthma Control Questionnaire (ACQ-5) score of 0.75 or higher); frequent acute exacerbations (≥2 per year) requiring oral corticosteroids, or severe acute exacerbations (≥1 per year) requiring emergency or hospitalization.
  • Willing to undergo a multidisciplinary, multi-dimensional evaluation and sign an informed consent form.
  • Must meet the criteria for severe asthma as outlined in the 2023 GINA guidelines

Who cannot join

  • Use macrolides within 4 weeks of the screening period
  • Use anti-IgE, anti-IL-5, or anti-IL-5R therapy within 4 weeks of the screening period
  • Use inhaled ICS + LABA + long-acting muscarinic antagonist (LAMA) within 4 weeks of the screening period
  • Be allergic to macrolides
  • Have a QTc interval prolongation of >480ms
  • Take a medication that interacts with azithromycin to prolong the QTc interval or cause existing ECG abnormalities, which may lead to arrhythmias.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China3 sites

  • Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Peking University Third Hospital

    Beijing, Haidian, 100191

  • Beijing Luhe Hospital affiliated to Capital Medical University

    Beijing, Tongzhou, 101199

Other trials in China

About this study

Official title: The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System

Severe or uncontrolled asthma is a complex heterogeneous disease, in which patients may exhibit different types of airway inflammation and often accompany multiple comorbidities and risk factors. Identifying potential modifiable factors that influence prognosis, i.e., "treatable traits," and targeting these traits for individualized, bundled management of patients may help improve the quality of life of asthma patients and enhance asthma control levels. This project aims to investigate the distribution of treatable traits in uncontrolled asthma patients in Beijing by conducting pulmonary function tests, exhaled nitric oxide tests, blood tests, allergen IgE tests, and chest CT scans, as well as detailed questionnaires, on patients from three tertiary hospitals in Beijing. The project will also assess the impact of treatable traits on the quality of life or asthma control levels of uncontrolled asthma patients in a multidimensional manner. Furthermore, the project will select severe asthma patients and establish an individualized, bundled management model based on the treatable traits of severe asthma, through multidisciplinary consultations and shared decision-making with patients. A randomized, parallel-group clinical trial will then be conducted for six months to confirm whether this management model is superior to conventional management in improving the quality of life or asthma control levels of severe asthma patients. The implementation of this project will establish a new model of individualized management for severe asthma based on treatable traits, thereby improving the management level of severe asthma.

Conditions
Asthma
Being tested
Individualized cluster management, Routine asthma treatment
Keywords
treatable traits, asthma, severe, AQLQ, ACQ
Medical subject headings
Asthma, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized cluster managementProcedure or surgery

    Individualized cluster management for treatable traits

  • Routine asthma treatmentProcedure or surgery

    Routine asthma treatment according to current guidelines

Study groups in NCT06811740
Study groupRoleWhat they receive
Intervention groupExperimentalImplement individualized cluster management based on treatable traits
Receives: Procedure: Individualized cluster management
PlaceboOtherRoutine asthma treatment according to current guidelines
Receives: Procedure: Routine asthma treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asthma Quality of life score (AQLQ)

    Changes in asthma Quality of life score (AQLQ) from baseline at 6 months；Asthma Quality of Life questionnaire (AQLQ) is a scoring scale to evaluate the quality of life of patients with asthma, evaluating the level of asthma control in the past 2 weeks. The AQLQ consisted of 32 questions, which were divided into four sub-areas: symptoms (12 questions), activity limitation (11 questions), emotional function (5 questions) and environmental stimulation (4 questions). Each question was scored on a scale of 1 to 7 points according to its severity, with 1 indicating complete limitation and 7 indicating no limitation at all. The total score is calculated as the average of all questions and the average of each partition.

    Measured: 6 months

Secondary outcomes (3)

  1. Asthma Control Questionnaire score (ACQ-5)

    Changes in Asthma Control Questionnaire score (ACQ-5) from baseline at 6 months；ACQ-5 (Asthma Control Questionnaire) is a scoring scale for assessing asthma control. It consists of 5 simple questions to assess a patient's level of asthma control in the past week. Each problem was scored on a scale of 0-6 according to its severity. The average score of the five problems <0.75 was asthma control, 0.75 ~ 1.5 was asthma partial control, and >1.5 was asthma uncontrolled.

    Measured: 6 months

  2. Forced Expiratory Volume in 1 second（FEV1）

    Changes in lung function Forced Expiratory Volume in 1 second（FEV1） from baseline

    Measured: 6 months

  3. Exacerbation

    the number of acute asthma attacks within 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06811740
Sponsor's protocol ID
2024-KE-338
Status last verified
Apr 2024
First submitted
5 Feb 2025
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rose L, Istanboulian L, Carriere L, Thomas A, Lee HB, Rezaie S, Shafai R, Fraser I. Program of Integrated Care for Patients with Chronic Obstructive Pulmonary Disease and Multiple Comorbidities (PIC COPD+): a randomised controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701567. doi: 10.1183/13993003.01567-2017. Print 2018 Jan.

    PubMed 29326330

  • Ko FW, Cheung NK, Rainer TH, Lum C, Wong I, Hui DS. Comprehensive care programme for patients with chronic obstructive pulmonary disease: a randomised controlled trial. Thorax. 2017 Feb;72(2):122-128. doi: 10.1136/thoraxjnl-2016-208396. Epub 2016 Jul 28.

    PubMed 27471050

  • McDonald VM, Fingleton J, Agusti A, Hiles SA, Clark VL, Holland AE, Marks GB, Bardin PP, Beasley R, Pavord ID, Wark PAB, Gibson PG; participants of the Treatable Traits Down Under International Workshop; Treatable Traits Down Under International Workshop participants:. Treatable traits: a new paradigm for 21st century management of chronic airway diseases: Treatable Traits Down Under International Workshop report. Eur Respir J. 2019 May 9;53(5):1802058. doi: 10.1183/13993003.02058-2018. Print 2019 May.

    PubMed 30846468

  • Wu WW, Zhang X, Li M, Liu Y, Chen ZH, Xie M, Zhao SZ, Wang G, Zhang HP, Wang T, Qin L, Wang L, Oliver BG, Wan HJ, Zhang J, McDonald VM, Marks GB, Li WM, Birring SS, Wang G, Gibson PG. Treatable Traits in Elderly Asthmatics from the Australasian Severe Asthma Network: A Prospective Cohort Study. J Allergy Clin Immunol Pract. 2021 Jul;9(7):2770-2782. doi: 10.1016/j.jaip.2021.03.042. Epub 2021 Apr 5.

    PubMed 33831621

  • McDonald VM, Hiles SA, Godbout K, Harvey ES, Marks GB, Hew M, Peters M, Bardin PG, Reynolds PN, Upham JW, Baraket M, Bhikoo Z, Bowden J, Brockway B, Chung LP, Cochrane B, Foxley G, Garrett J, Jayaram L, Jenkins C, Katelaris C, Katsoulotos G, Koh MS, Kritikos V, Lambert M, Langton D, Lara Rivero A, Middleton PG, Nanguzgambo A, Radhakrishna N, Reddel H, Rimmer J, Southcott AM, Sutherland M, Thien F, Wark PAB, Yang IA, Yap E, Gibson PG. Treatable traits can be identified in a severe asthma registry and predict future exacerbations. Respirology. 2019 Jan;24(1):37-47. doi: 10.1111/resp.13389. Epub 2018 Sep 19.

    PubMed 30230137

  • McDonald VM, Clark VL, Cordova-Rivera L, Wark PAB, Baines KJ, Gibson PG. Targeting treatable traits in severe asthma: a randomised controlled trial. Eur Respir J. 2020 Mar 5;55(3):1901509. doi: 10.1183/13993003.01509-2019. Print 2020 Mar.

    PubMed 31806719

Questions about this trial

What is this clinical trial studying?

A study testing Individualized cluster management and Routine asthma treatment in people with Asthma, run by Beijing Chao Yang Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma Quality of life score (AQLQ) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06811740, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.

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