An observational study in Asthma and COPD, sponsored by AstraZeneca. Recruiting at 12 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by AstraZeneca · Observational
Among 330 studies in Asthma by AstraZeneca — 17 open to participants now, 28 under way, 7 of them phase 3. Asthma · AstraZeneca.
Among the 330 studies in Asthma by AstraZeneca, this one is the 50th largest by planned enrollment of the 107 observational ones that give a count, is one of 13 that started in 2025, is one of 108 observational ones, reaches primary completion later than 7 of the 27 other live ones, and was the 321st registered.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 600 is above the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →17 of the 330 studies in Asthma by AstraZeneca are open now, in 12 countries. Each count lists the studies.
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →330 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 38 · Phase 2 36 · Phase 3 120 · Phase 4 23
First in 1996; this study’s year is marked. 13 started in 2025.
Median enrollment 196 across the 222 interventional studies, 500 across the 107 observational. Of the 301 that completed or were terminated, 107 (36%) have results posted.
AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
12 of the studies in Asthma by AstraZeneca that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692180Phase 3AstraZenecaA Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma | 2026-12-23 |
| NCT06473779Phase 3AstraZenecaOpen-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. | 2027-06-25 |
| NCT06471257Phase 3AstraZenecaA Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma | 2027-10-04 |
| NCT06307665Phase 3AstraZenecaEvaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma | 2027-10-13 |
| NCT07218172AstraZenecaCharacterization and Clinical Outcomes of Severe Asthma Patients in Israel Treated With Benralizumab (SAIL-B) | 2026-11-30 |
Among the 330 studies in Asthma by AstraZeneca, from their registry updates:
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 traditional spirometry.
This observational study is designed to evaluate the diagnostic accuracy and technical feasibility of using oscillometry and FeNO testing in primary care for suspected asthma and COPD, compared to conventional specialist-based diagnostics. The study will be conducted across 7 countries in the MEA, Asia, and Latin America, with two hospital sites per country. Primary care physicians will be trained in oscillometry and FeNO testing using standardized protocols and tools such as the Ambulatory Lung Diagnosis System following GINA and GOLD guidelines. Eligible patients will provide consent, complete a history and symptom questionnaire, and undergo primary care-based assessment for a provisional diagnosis. If specialist assessment cannot occur the same day, it will be done within three days. No follow-up visits are planned. Study outcomes will inform the feasibility and accuracy of integrating these methods into routine care, aiming to improve the early and reliable diagnosis of asthma and COPD.
Diagnosis of asthma and chronic obstructive pulmonary disease (COPD) currently relies heavily on pulmonary function tests (PFTs), with spirometry as the core method. However, the effectiveness of spirometry is closely linked to patients' ability to perform maximal, forceful breathing maneuvers. This poses difficulties for individuals with varying physical capacities, leading to challenges in test use, result interpretation, and reproducibility. Such limitations often require skilled specialists, which may not be available in all settings, especially in primary care.
Primary care providers are the initial interface for patients with respiratory symptoms, tasked with rapidly evaluating and diagnosing conditions during brief patient interactions. Early diagnosis of asthma and COPD is crucial, yet spirometry standards-such as those set by the European Respiratory Society and American Thoracic Society-often cannot be met in primary care due to resource and expertise constraints. Operational barriers, including equipment costs, maintenance, staff training, and integration into routine practice, further hinder widespread adoption of spirometry.
Adding to the complexity, variable bronchodilator responsiveness complicates the differential diagnosis of obstructive airway diseases. Traditional reversibility criteria based on FEV1 changes following bronchodilator administration may be unreliable, reducing their diagnostic utility for distinguishing asthma from COPD and highlighting the need for multidimensional approaches.
Oscillometry is emerging as a promising alternative or adjunct to spirometry. It is a non-invasive method capable of detecting airway resistance and reactance, which can reveal early functional changes in asthma and COPD-even before clinical symptoms appear. Oscillometry is valuable for monitoring disease progression, assessing bronchodilator response, and may be more sensitive for small airway dysfunction, especially in patients with normal or slightly impaired lung function.
Measurement of fractional exhaled nitric oxide (FeNO) is another innovative technique. As a marker for T-helper 2 cell-mediated airway inflammation, FeNO can enhance the diagnosis and monitoring of asthma. Guidelines recommend FeNO thresholds for diagnosis and management, adding an objective layer to clinical decision-making. International guidelines advise integrating FeNO and additional objective tests, such as eosinophil counts, with standard PFTs to support asthma diagnosis.
Addressing the considerable unmet need for earlier identification of asthma and COPD a multicenter, multinational, cross-sectional, observational study designed to evaluate the diagnostic accuracy of primary care-based diagnosis for asthma or COPD using oscillometry and FeNO test (combined), compared to specialist care-based diagnosis using usual practice is being conducted across 7 countries in the Middle East and Africa, Asia, and Latin America, the study will systematically compare primary care-based diagnosis using combined oscillometry and FeNO testing with conventional specialist-led diagnostics.
Patients with suspected asthma or COPD will be enrolled from outpatient departments during a six-month recruitment period. Participating primary care physicians will be trained according to Global Initiative for Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, and equipped with tools such as the Ambulatory Lung Diagnosis System. Recruitment will avoid sites biased toward severe cases, ensuring a representative patient population. Provisional diagnoses will be established via history, symptom questionnaires, and results of oscillometry and FeNO testing; where immediate specialist assessment is not feasible, patients will return within three days for further evaluation. No follow-up visits are planned. The study aims to inform clinical practice by clarifying the feasibility and effectiveness of integrating these innovative diagnostic methods into primary care, with the goal of facilitating earlier and more reliable identification of asthma and COPD.
Total of 600 patients (approximately 300 suspected asthma patients and 300 suspected COPD patients) will be enrolled in this study. The patients will be enrolled in asthma or COPD groups in 1:1 ratio at site-level. Each site will enroll 50 patients (approximately 25 suspected asthma and 25 suspected COPD).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients are eligible to be included in the study if all the following criteria apply and after providing written :
Suspected asthma (asthma group)
Suspected (COPD group)
Exclusion Criteria:
Patients are excluded from the study if any of the following criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Accuracy of primary care asthma/COPD diagnosis using oscillometry (ALDS: R5, R20, R5-R20, X5, Ax) plus FeNO ≥50 ppb (Fenom PRO®/ALDS Pro) vs specialist gold standard; metrics: Cohen's kappa, agreement, sensitivity, specificity in overall, asthma, COPD
Primary care diagnosis uses a diagnostic algorithm combining oscillometry and FeNO. Oscillometry: Ambulatory Lung Diagnosis System (ALDS) parameters-respiratory system resistance at 5 Hz (R5), resistance at 20 Hz (R20), difference R5-R20, reactance at 5 Hz (X5), and area of reactance (Ax). FeNO: measured with Fenom PRO® or ALDS Pro devices, using a diagnostic cut-off of ≥50 ppb. Specialist care diagnosis is the comparator: Gold Standard Specialist Care Diagnosis established through standard clinical practice, including pulmonary function tests, spirometry, physiological tests, imaging, laboratory tests, and bronchial provocation tests. Accuracy will be quantified using Cohen's Kappa coefficient, Percentage Agreement, Sensitivity, and Specificity. The analysis will be conducted in the overall population, the asthma group, and the COPD group.
Time frame: 1 to 3 days
accuracy and agreement between asthma or COPD diagnoses made in primary care with provisional diagnoses derived exclusively from patient history compared to specialist settings diagnosis
To evaluate the accuracy and agreement between asthma or COPD diagnoses made in primary care with provisional diagnoses derived exclusively from patient history compared to specialist settings diagnosis
Time frame: 1 to 3 days
Healthcare provider satisfaction with primary care diagnostic tests (oscillometry and FeNO) as measured by a 5-point Likert scale (ranging from 1 'not satisfied at all' to 5 'very satisfied', where higher scores indicate greater satisfaction)
This directly measures the satisfaction scores or experience rating (as per Protocol Section 2, Table 1 and Section 3.1.1.1) using the specified 5-point Likert scale, including its range and interpretation, addressing both Major and Advisory Issues
Time frame: 1 to 3 days
Primary care provider confidence in their diagnosis (for this patient) as measured by a 5-point Likert scale (ranging from 1 'not at all confident' to 5 'extremely confident', where higher scores indicate greater confidence)
This measures the confidence scores (as per Protocol Section 2, Table 1 and Section 3.1.1.1) of primary care providers in their diagnostic assessment using the specified 5-point Likert scale, including its range and interpretation.
Time frame: 1 to 3 days
Specialist care provider experience with the diagnostic process at secondary care as measured by a 5-point Likert scale (ranging from 1 'very challenging' to 5 'very straightforward', where higher scores indicate a more straightforward experience)
This measures the experience scores (as per Protocol Section 2, Table 1 and Section 3.1.1.1) of specialist care providers with the diagnostic process, utilizing the specified 5-point Likert scale, including its range and interpretation.
Time frame: 1 to 3 days
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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.
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Apr 2027, 16 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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