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New treatment option for Suspected Asthma
Official title Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis
ClinicalTrials.gov ID: NCT07516184
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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)...
You likely can't join if
- 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...
- 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...
- History of serious comorbidities, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal...
- Affect the safety of the patient throughout the study,
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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 treatment clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Cangzhou, China
- Changsha, China
- Chengdu, China
- Chongqing, China
- Guangzhou, China
- Kunming, China
- Quanzhou, China
- Shanghai, China
- Suzhou, China
- Taiyuan, China
- Tianjin, China
- Ürümqi, China
- Wuhan, China
- Xi'an, China
- Yangzhou, China
- Zhengzhou, China
- Zhuhai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Cangzhou, China; Changsha, China; Chengdu, China; Chongqing, China; Guangzhou, China and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.