A new strategy puts asthma guidelines to the test — could it cut flare-ups in half?
NCT ID NCT07718724
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial tests whether a structured care pathway — based on standard asthma guidelines — can improve disease management for adults with uncontrolled asthma who already use high-dose inhalers. Doctors and nurses at some clinics will receive extra training and tools to follow the guidelines closely, while others continue usual care. The study will compare rates of severe asthma diagnoses and flare-ups over nearly a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a guideline-directed medical therapy (GDMT) pathway for physicians and nurses
- What this could lead to
- If successful, this approach could improve asthma control and reduce severe flare-ups for people whose asthma is not well managed by standard inhalers.
- What could go wrong
- This is a behavioral intervention, not a new drug, so its impact may be modest. Results depend on how consistently doctors and nurses follow the pathway.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 540 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Northan Jiangsu People's Hospital
Yangzhou, China
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