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NCT07718724From ClinicalTrials.govRecruiting

Impact of GDMT in Uncontrolled Asthma Patients Receiving MHD Inhaled Corticosteroids + Long-acting β2 Agonist

A Prospective, Multicenter, Cluster-Randomized Trial to Evaluate the Impact of Guideline-Directed Medical Therapy in Uncontrolled Asthma Patients Receiving Medium-to-High Dose Inhaled Corticosteroids Plus Long-acting β2 Agonist

  • Uncontrolled Asthma

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
AstraZeneca
Enrolment target
540
Started
5 September 2026
Main results due
30 April 2028
Study sites
20
Registry updated
24 September 2026

Can you take part?

  • No age limit is stated.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

1. Sign the informed consent form before any study-related procedures;
2. Age 18-75 years (inclusive) at Visit 0;
3. Have a written diagnosis of asthma for more than 6 months prior to Visit 0, and have evidence of reversible airflow limitation prior to Visit 0. Evidence of reversible airflow limitation includes: post-bronchodilator increase in Forced Expiratory Volume in 1 second (FEV1) of ≥12% and an absolute increase of ≥200 mL, or average daily diurnal Peak Expiratory Flow (PEF) variability \>10%, or an increase in FEV1 of ≥12% and an absolute increase of ≥200 mL compared to baseline after 4 weeks of treatment containing ICS, or a positive bronchial provocation test record. If no prior record exists, reversible airflow limitation must be confirmed and documented via a bronchodilator test during Visit 0;
4. Under the usage of MD/HD ICS-LABA;
5. Experienced one or more exacerbations within the past year;

Exacerbation is defined as meeting any of the following criteria:

1. Use of systemic corticosteroids (or a temporary increase in the stable dose of baseline oral corticosteroids) for at least 3 days; a single injection of a depot long-acting corticosteroid can be considered equivalent to a 3-day course of systemic corticosteroids;
2. An emergency department or urgent care site visit for asthma (defined as being evaluated and treated in the emergency department or urgent care site for \< 24 hours) requiring the use of systemic corticosteroids for at least 3 days (as described above);
3. Hospitalization for asthma (defined as admission to a hospital and/or being evaluated and treated in a healthcare facility for ≥ 24 hours).

Exclusion Criteria:

1. Previous written diagnosis as "Severe Asthma"; Diagnosis of Severe Asthma includes: severe asthma, or related diagnoses containing "severe asthma", or "bronchial asthma (severe)".
2. Imaging suggests the presence of bullae or cystic bronchiectasis;
3. Currently participating in other interventional studies;
4. Previous use of biologics for asthma treatment;
5. Using systemic glucocorticoids for other diseases;
6. History of respiratory tract infection within 4 weeks prior to Visit 0 (upper respiratory tract infections and lower respiratory tract infections);
7. Any significant disease or disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine/metabolic, malignant, psychiatric, or significant physical impairment, etc.) which, in the opinion of the investigator, may put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to comply with GDMT.

What this study is about

In the sponsor’s own words, from the registry.

The primary objective of this study is to evaluate whether GDMT can bring significant benefits to disease management in uncontrolled asthma patients receiving medium- to high-dose ICS-LABA.

* The intervention period will be up to 48 weeks; * The frequency of follow-up is every 12 weeks.

Study sites(20)

  • Research Site

    Chengdu, China

    Not yet recruiting

  • Research Site

    Chifeng, China

    Recruiting

  • Research Site

    Dongyang, China

    Not yet recruiting

  • Research Site

    Hefei, China

    Not yet recruiting

  • Research Site

    Hefei, China

    Not yet recruiting

  • Research Site

    Hengyang, China

    Not yet recruiting

  • Research Site

    Heze, China

    Not yet recruiting

  • Research Site

    Jiaxing, China

    Not yet recruiting

  • Research Site

    Langfang, China

    Not yet recruiting

  • Research Site

    Meizhou, China

    Not yet recruiting

  • Research Site

    Quanzhou, China

    Not yet recruiting

  • Research Site

    Shanghai, China

    Not yet recruiting

  • Research Site

    Shiyan, China

    Not yet recruiting

  • Research Site

    Tai’an, China

    Not yet recruiting

  • Research Site

    Ürümqi, China

    Not yet recruiting

  • Research Site

    Xi'an, China

    Not yet recruiting

  • Research Site

    Yantai, China

    Not yet recruiting

  • Research Site

    Yongzhou, China

    Not yet recruiting

  • Research Site

    Yunnan, China

    Not yet recruiting

  • Research Site

    Zhanjiang, China

    Not yet recruiting

Showing 20 of 20 sites. 1 of the 20 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07718724. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Impact of GDMT in Uncontrolled Asthma Patients Receiving MHD Inhaled Corticosteroids + Long-acting β2 Agonist | Trialion