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โ† Trials
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Assess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis

Recruitingn/aAges 18 Years - anyAllAstraZeneca
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In plain words

What the trial is, and whether it could suit you

Current diagnostic methods for asthma and chronic obstructive pulmonary disease mostly depend on pulmonary function tests, especially spirometry. While spirometry is a foundational tool, its diagnostic accuracy is often limited by the patient's ability to perform forceful breathing maneuvers, as well as technical and reproducibility challenges, and the need for proper equipment and training. These constraints can compromise effective diagnosis of asthma and COPD in primary care settings. Prompt and accurate diagnosis by primary care physicians is essential for better patient outcomes. Although variable airflow limitation often measured as a change in FEV1 after bronchodilator is a hallmark of asthma, inconsistencies in test quality and reversibility criteria create challenges in distinguishing asthma from COPD. These complexities highlight the need for alternative diagnostic tools beyond

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Patients are eligible to be included in the study if all the following criteria apply and after providing written informed consent: Suspected asthma (asthma group) 1. Patients โ‰ฅ 18 years old or with legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the ICF. 2. Patients presenting with symptoms of wheezing, cough, chest tightness, shortness of breath, but without a clinically confirmed diagnosis of asthma. Suspected COPD (COPD group) 1. Patients โ‰ฅ 40 years old at the time of signing the ICF. 2. Patients presenting with symptoms of dyspnea, chronic cough or sputum production, but without a clinically confirmed diagnosis of COPD. Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: 1. Prior diagnosis of COPD or asthma. 2. Use of ICS in the last 6 months or use of oral corticosteroids in the last 3 months. 3. Any diseases that influence lung function result such as lung cancer, pneumonia, active pulmonary tuberculosis, pulmonary embolism, and interstitial lung disease. 4. Any history of recent surgery that affects lung function results, including but not limited to thoracotomy surgery, pneumothorax surgery, and thoracic drainage. 5. Contraindication to spirometry or oscillometry test, or allergy to bronchodilator. 6. Currently pregnant or breast-feeding women. 7. If the investigator judges that the patient is unlikely to comply with study procedures, restrictions, and requirements.
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What it tests

  • Not listed
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Where

12 sites
Research Site
Buenos Aires, Argentina
Research Site
Medoza, Argentina
Research Site
Alexandria, Egypt
Research Site
El Waili, Egypt
Research Site
Monterrey, Mexico
Research Site
Santiago de Quer Taro, Mexico
Research Site
Riyadh, Saudi Arabia
Research Site
Taichung, Taiwan

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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