Suspected Asthma
Conditions
Brief 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). 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.
Interventions
DEVICEPulmonary function Test intervention
enrollment 500 suspect asthma patients
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a single group study and plan to enroll 500 suspect asthma patients
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet all the following criteria and sign an informed consent form (ICF) to be eligible for the study. 1. Patient must be aged 18-75 years old at the time of enrollment. 2. 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.
Exclusion criteria
Patients are excluded from the study if any of the following criteria apply: Medical Conditions 1. 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. 2. 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. 3. History of other chronic respiratory diseases other than asthma, including but not limited to tuberculosis, significant bronchiectasis, established interstitial lung disease, and lung cancer. 4. 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: 1. Affect the safety of the patient throughout the study, 2. Confound the study results or impact the scientific validity of the data outcome, 3. Impede the patient's ability to complete the entire duration of study. 5. Positive urine pregnancy test, or breastfeeding women, or any women who are planning to become pregnant (current and within 3 months). Prior/Concomitant Therapy 6. 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 7. 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. 8. Current participation in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To explore the diagnostic value of portable oscillometry in suspected asthma patients | day 0~7 | PPV (Positive predictive value)(spiro diagnosed asthma/osci BDT ve+) of BDT(Bronchodilation test) with portable oscillomtery in asthma diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the consistency of portable oscillometry BD test with spirometry BDT/BPT in suspected asthma patients | day 0~7 | 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 |
| To evaluate the diagnostic performance of portable oscillometry in suspected asthma patients | day 0~7 | 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. |
| To evaluate the diagnostic performance of spirometry in suspected asthma patients | day 0~7 | 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. |
| To evaluate if performing BDT with spirometry and with oscillometry is superior to either test alone | day 0~7 | 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+. |
| To evaluate the diagnostic performance of portable oscillometry in asthma patients by lung functions impairment status | day 0~7 | PPV and NPV of BDT with portable oscillometry in asthma patients with FEV1%≥70% and FEV1%\<70%, respectively. |
| To explore the diagnostic value of single parameter or combination of parameters in asthma patients | day 0~7 | 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. |
| To explore the diagnostic performance of BDT with portable oscillometry based on thresholds from other studies | day 0~7 | 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%. |
| To describe the change in pulmonary function parameters measured by portable oscillometry before and after bronchodilator use in diagnosed asthma patients | day 0~7 | Mean ± SD and percentile ranges (P₂.₅-P₉₇.₅) of the optimal oscillometry BDT variables (e.g., ΔRrs, ΔXrs, ΔAX) in diagnosed asthma patients. |
Countries
China
Contacts
CONTACTAstraZeneca Clinical Study Information Center
PRINCIPAL_INVESTIGATORKeWu Huang, Doctor
Beijing Chao-Yang Hospital, 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, China
PRINCIPAL_INVESTIGATORMin Zhang, Doctor
No. 85/86, Wujin Road, Hongkou District, Shanghai
Outcome results
None listed