Suspected AsthmaSOLANCT07516184
Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis
A study testing Pulmonary function Test intervention in people with Suspected Asthma, run by AstraZeneca at 24 sites in China.
Trial summary
This is a multi-center study to explore the positive predictive value of bronchodilation test with portable oscillometry compared to either BDT or BPT with spirometry in asthma diagnosis and to compare it with bronchodilation with spirometry (the current gold standard). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Suspected Asthma
- What is being tested?
- Pulmonary function Test intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 24 sitesChina
- Study dates
- 10 Jun 2026to 11 Jun 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all the following criteria and sign an informed consent form (ICF) to be eligible for the study.
- Patient must be aged 18-75 years old at the time of enrollment.
- Presented with asthmatic symptoms such as wheezing, shortness of breath, chest tightness and cough ≥2 months prior to enrollment (Day 0), with/without an established asthma diagnosis.
Who cannot join
- Patients are excluded from the study if any of the following criteria apply:
- Medical Conditions
- Respiratory infections within 3 months prior to enrollment (Day 0), including but not limited to: acute bacterial/viral pneumonia, acute bronchitis, Influenza, COVID-19 or acute exacerbation of chronic bronchitis.
- Current smoker; or cessation from smoking less than 6 months; or cessation smoking for more than 6 months but smoked more than 10 packs/year.
- History of other chronic respiratory diseases other than asthma, including but not limited to tuberculosis, significant bronchiectasis, established interstitial lung disease, and lung cancer.
- History of serious comorbidities, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
Show all 16Show fewer
- Affect the safety of the patient throughout the study,
- Confound the study results or impact the scientific validity of the data outcome,
- Impede the patient's ability to complete the entire duration of study.
- Positive urine pregnancy test, or breastfeeding women, or any women who are planning to become pregnant (current and within 3 months).
- Prior/Concomitant Therapy
- ICS-based medication (including ICS, ICS/LABA, ICS/LABA/LAMA) use within 3 months prior to enrollment (Day 0).
- ICS=inhaled corticosteroids; LABA=long-acting β2 agonists; LAMA=long-acting muscarinic antagonists.
- Other Exclusions
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- Current participation in another interventional clinical trial.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
Research Site
Beijing, 100000
- Recruiting
Research Site
Cangzhou, 061000
- Not yet recruiting
Research Site
Changsha, 410008
- Recruiting
Research Site
Changsha, 430033
- Recruiting
Research Site
Chengdu, 610041
- Recruiting
Research Site
Chongqing, 400016
- Recruiting
Research Site
Guangzhou, 510000
- Not yet recruiting
Research Site
Guangzhou, 510120
- Recruiting
Research Site
Guangzhou, 510630
- Not yet recruiting
Research Site
Kunming, 650032
- Recruiting
Research Site
Quanzhou, 362000
- Not yet recruiting
Research Site
Shanghai, 200032
- Recruiting
Research Site
Shanghai, 200065
- Recruiting
Research Site
Shanghai, 200080
- Not yet recruiting
Research Site
Shanghai, 200433
- Not yet recruiting
Research Site
Suzhou, 215006
- Recruiting
Research Site
Taiyuan, 030001
- Not yet recruiting
Research Site
Tianjin, 300192
- Recruiting
Research Site
Ürümqi, 830054
- Recruiting
Research Site
Wuhan, 430048
- Recruiting
Research Site
Xi'an, 710004
- Recruiting
Research Site
Yangzhou, 225001
- Recruiting
Research Site
Zhengzhou, 450000
- Recruiting
Research Site
Zhuhai, 519000
About this study
Official title: A Multicentre Study to Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis
This is a multi-center study to explore the positive predictive value of bronchodilation test with portable oscillometry compared to either BDT or BPT with spirometry in asthma diagnosis and to compare it with bronchodilation with spirometry (the current gold standard). In the study, the target patients' profile is the suspected asthma patient with asthmatic symptoms (wheezing, shortness of breath, chest tightness, and/or cough) and aim to enroll 500 participants from 25 sites across different regions in China.
Read the detailed description
Following the completion of informed consent procedures, patients with asthmatic symptoms will proceed to enrollment for inclusion and exclusion criteria review. In addition, blood tests, include complete blood count (CBC) and C-reactive protein (CRP), and chest Computed Tomography (CT) will be done for eligible participants prior to all assessments in the study to ensure excluding participants with respiratory infections and any lung diseases (other than asthma).
All the included participants will undergo Fractional exhaled nitric oxide (FeNO) test, BDT with portable oscillometry and spirometry in sequence and complete the Asthma Control Questionnaire-5 (ACQ-5) assessment during Visit 1. For participants with pre-BD FEV1% ≥ 70% will undergo BPT with spirometry as the last assessment in the study.
The diagnosis of asthma will be defined as positive BDT (after bronchodilator inhalation, FEV1 increased by ≥12%, and the absolute value of FEV1 increased by ≥200 mL) or positive BPT with spirometry (FEV1% decrease ≥20% after methacholine inhalation). Oscillometry BDT positive is defined as R5 decrease 40%, or X5 increase 50%, or AX decrease 80% after bronchodilator inhalation as recommended in ERS consensus.
- Conditions
- Suspected Asthma
- Being tested
- Pulmonary function Test intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary function Test interventionDevice
enrollment 500 suspect asthma patients
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary function Test intervention | Other | enrollment 500 suspect asthma patients Receives: Device: Pulmonary function Test intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the diagnostic value of portable oscillometry in suspected asthma patients
PPV (Positive predictive value)(spiro diagnosed asthma/osci BDT ve+) of BDT(Bronchodilation test) with portable oscillomtery in asthma diagnosis
Measured: day 0~7
Secondary outcomes (8)
To evaluate the consistency of portable oscillometry BD test with spirometry BDT/BPT in suspected asthma patients
Kappa coefficient between oscillometry BDT and spirometry BDT/BPT and NPV (non-asthma diagnosed by spiro/osci BDT ve-) of BDT with portable oscillometry in asthma diagnosis
Measured: day 0~7
To evaluate the diagnostic performance of portable oscillometry in suspected asthma patients
Sensitivity (osci BDT ve+/spiro diagnosed asthma) and specificity (osci BDT ve-/non-asthma diagnosed by spiro) of BDT with portable oscillometry in asthma diagnosis.
The proportion of osci BDT ve+ who have spiro BPT positive.
Measured: day 0~7
To evaluate the diagnostic performance of spirometry in suspected asthma patients
Sensitivity (spiro BDT ve+/spiro diagnosed asthma) of BDT with spirometry in asthma diagnosis.
The proportion of spiro BDT ve+ who have spiro BPT positive.
Measured: day 0~7
To evaluate if performing BDT with spirometry and with oscillometry is superior to either test alone
The proportion of osci BDT ve+ who have spiro BDT positive. The proportion of osci BDT ve+ (excluding who have spiro BDT positive) who have spiro BPT positive.
The number of asthma patients based on spiro BPT/BDT ve+, who have only osci BDT ve+ or spiro BDT ve+.
Measured: day 0~7
To evaluate the diagnostic performance of portable oscillometry in asthma patients by lung functions impairment status
PPV and NPV of BDT with portable oscillometry in asthma patients with FEV1%≥70% and FEV1%<70%, respectively.
Measured: day 0~7
To explore the diagnostic value of single parameter or combination of parameters in asthma patients
Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for individual or combination of any parameter of portable oscillometry together with or without FeNO and/or EOS in asthma diagnosis.
Measured: day 0~7
To explore the diagnostic performance of BDT with portable oscillometry based on thresholds from other studies
The proportion of osci BDT ve+ according to the following thresholds reported in other studies.
R5 decrease ≥32% or X5 increase ≥44% or AX decrease ≥65%. R5 decrease ≥29% or X5 increase ≥45%.
Measured: day 0~7
To describe the change in pulmonary function parameters measured by portable oscillometry before and after bronchodilator use in diagnosed asthma patients
Mean ± SD and percentile ranges (P₂.₅-P₉₇.₅) of the optimal oscillometry BDT variables (e.g., ΔRrs, ΔXrs, ΔAX) in diagnosed asthma patients.
Measured: day 0~7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start10 Jun 2026
- Primary completion11 Jun 2027 (estimated)
- Study completion11 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group study and plan to enroll 500 suspect asthma patients
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KeWu Huang, Doctor, Principal investigator, Beijing Chao-Yang Hospital, 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, ChinaMin Zhang, Doctor, Principal investigator, No. 85/86, Wujin Road, Hongkou District, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516184
- Sponsor's protocol ID
- D2287C00013
- Acronym
- SOLA
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Study to Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis
- ClinicalTrials.gov ID
- NCT07516184
- Acronym / sponsor ID
- SOLA / D2287C00013
- Conditions
- Suspected Asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 11 Jun 2027 (estimated)
- Study completion
- 11 Jun 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center study to explore the positive predictive value of bronchodilation test with portable oscillometry compared to either BDT or BPT with spirometry in asthma diagnosis and to compare it with bronchodilation with spirometry (the current gold standard). In the study, the target patients' profile is the suspected asthma patient with asthmatic symptoms (wheezing, shortness of breath, chest tightness, and/or cough) and aim to enroll 500 participants from 25 sites across different regions in China.
Detailed description
Following the completion of informed consent procedures, patients with asthmatic symptoms will proceed to enrollment for inclusion and exclusion criteria review. In addition, blood tests, include complete blood count (CBC) and C-reactive protein (CRP), and chest Computed Tomography (CT) will be done for eligible participants prior to all assessments in the study to ensure excluding participants with respiratory infections and any lung diseases (other than asthma).
All the included participants will undergo Fractional exhaled nitric oxide (FeNO) test, BDT with portable oscillometry and spirometry in sequence and complete the Asthma Control Questionnaire-5 (ACQ-5) assessment during Visit 1. For participants with pre-BD FEV1% ≥ 70% will undergo BPT with spirometry as the last assessment in the study.
The diagnosis of asthma will be defined as positive BDT (after bronchodilator inhalation, FEV1 increased by ≥12%, and the absolute value of FEV1 increased by ≥200 mL) or positive BPT with spirometry (FEV1% decrease ≥20% after methacholine inhalation). Oscillometry BDT positive is defined as R5 decrease 40%, or X5 increase 50%, or AX decrease 80% after bronchodilator inhalation as recommended in ERS consensus.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group study and plan to enroll 500 suspect asthma patients
| Arm | Type | Receives |
|---|---|---|
| Pulmonary function Test intervention | Other | Device: Pulmonary function Test interventionenrollment 500 suspect asthma patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must meet all the following criteria and sign an informed consent form (ICF) to be eligible for the study.
- Patient must be aged 18-75 years old at the time of enrollment.
- Presented with asthmatic symptoms such as wheezing, shortness of breath, chest tightness and cough ≥2 months prior to enrollment (Day 0), with/without an established asthma diagnosis.
Key exclusion criteria (16 listed)
- Medical Conditions
- Respiratory infections within 3 months prior to enrollment (Day 0), including but not limited to: acute bacterial/viral pneumonia, acute bronchitis, Influenza, COVID-19 or acute exacerbation of chronic bronchitis.
- Current smoker; or cessation from smoking less than 6 months; or cessation smoking for more than 6 months but smoked more than 10 packs/year.
- History of other chronic respiratory diseases other than asthma, including but not limited to tuberculosis, significant bronchiectasis, established interstitial lung disease, and lung cancer.
- History of serious comorbidities, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary function Test interventionenrollment 500 suspect asthma patients | Device | Pulmonary function Test intervention |
Primary outcome
To explore the diagnostic value of portable oscillometry in suspected asthma patients
Time frame: day 0~7
PPV (Positive predictive value)(spiro diagnosed asthma/osci BDT ve+) of BDT(Bronchodilation test) with portable oscillomtery in asthma diagnosis
8 secondary outcomes
To evaluate the consistency of portable oscillometry BD test with spirometry BDT/BPT in suspected asthma patients
Time frame: day 0~7
To evaluate the diagnostic performance of portable oscillometry in suspected asthma patients
Time frame: day 0~7
To evaluate the diagnostic performance of spirometry in suspected asthma patients
Time frame: day 0~7
To evaluate if performing BDT with spirometry and with oscillometry is superior to either test alone
Time frame: day 0~7
To evaluate the diagnostic performance of portable oscillometry in asthma patients by lung functions impairment status
Time frame: day 0~7
To explore the diagnostic value of single parameter or combination of parameters in asthma patients
Time frame: day 0~7
To explore the diagnostic performance of BDT with portable oscillometry based on thresholds from other studies
Time frame: day 0~7
To describe the change in pulmonary function parameters measured by portable oscillometry before and after bronchodilator use in diagnosed asthma patients
Time frame: day 0~7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Suspected Asthma
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PROPULSION SANTE: Inflammometry to Improve the Diagnostic Trajectory in Situations of Suspected Asthma in Children and Adults
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
KeWu Huang, Doctor principal investigator
Beijing Chao-Yang Hospital, 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, China
Min Zhang, Doctor principal investigator
No. 85/86, Wujin Road, Hongkou District, Shanghai
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary function Test intervention in people with Suspected Asthma, run by AstraZeneca at 24 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 3 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the diagnostic value of portable oscillometry in suspected asthma patients (time frame: day 0~7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.