An observational study in Asthma, Uncontrolled Asthma and Asthma-COPD Overlap, sponsored by AstraZeneca. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by AstraZeneca · Observational
Among 358 studies in Asthma by AstraZeneca — 18 open to participants now, 28 under way, 7 of them phase 3. Asthma · AstraZeneca.
Among the 358 studies in Asthma by AstraZeneca, this one is the 91st largest by planned enrollment of the 110 observational ones that give a count, is the only one that started in 2027, is one of 111 observational ones, reaches primary completion later than 13 of the 27 other live ones, and was the 358th registered.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
Browse Asthma studies →18 of the 358 studies in Asthma by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
AstraZeneca · Sites in China
AstraZeneca · Sites in United States, Argentina, Austria and 11 more countries
Ages 6+
AstraZeneca · Sites in China
Ages 18–75
AstraZeneca · Sites in United States, Argentina, Czechia and 4 more countries
Ages 4–11
By country, each count listing its 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 →This tab as a report to print or save as PDF → With an account.
358 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 46 · Phase 2 52 · Phase 3 122 · Phase 4 23
First in 1996; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 158 across 1,250 observational studies indexed under Asthma.
Median enrollment 174 across the 247 interventional studies, 500 across the 110 observational. Of the 329 that completed or were terminated, 129 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,502 studies on the registry; 273 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
13 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 |
Add all 13 to your calendar (.ics) → With an account.
Among the 358 studies in Asthma by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a single arm, prospective non-interventional study with primary data collection in patients initiated BGF MDI treatment as part of routine clinical care. In this study, 200 patients will be enrolled from approximately 20 sites mainly in general hospitals with respiratory/allergy/asthma specialists in Japan.
The study population will be composed of 200 patients with asthma who are newly initiated BGF MDI treatment and who can regularly visit the study site in Japan.
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.
Exclusion Criteria:
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.
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.
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.
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.
The study population will include approximately 200 adult patients with asthma in Japan who are newly initiated BGF MDI treatment, have an ACQ-5 score ≥1.5 at enrollment.
Drug: Budesonide/Glycopyrronium/Formoterol fumarate metered dose inhaler
Initiation of BGF MDI treatment in routine clinical practice.
Also known as: BGF MDI
Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score
To evaluate the change in asthma control at 8 weeks from baseline in patients with asthma initiated on BGF MDI, as measured by ACQ-5.
Time frame: at Week 8
Change in asthma control measured by ACQ-5 at 8 weeks from baseline in the asthma patients initiated with BGF MDI, separately in patients with and without prior inhaled maintenance treatment
To evaluate changes in asthma control measured by ACQ-5 at 8 weeks from baseline in the asthma patients initiated with BGF MDI, separately in patients with and without prior inhaled maintenance treatment (defined in 3.5)
Time frame: at week 8 from baseline
Changes in asthma control measured by ACQ-5
To evaluate changes in asthma control measured by ACQ-5 at 2 and 4 weeks from baseline in the asthma patients initiated with BGF MDI
Time frame: at week 2 and 4 from baseline
Changes in the disease specific Health-related Quality of Life (HRQoL) measured by Mini Asthma Quality of Life Questionnaire (Mini AQLQ)
To evaluate changes in the disease specific Health-related Quality of Life (HRQoL) measured by Mini Asthma Quality of Life Questionnaire (Mini AQLQ) at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI
Time frame: at weeks 2, 4 and 8 from baseline
Proportion of patients initiated with BGF MDI who achieve the minimal clinically important difference (MCID) in ACQ-5
To evaluate proportion of patients initiated with BGF MDI who achieve the minimal clinically important difference (MCID) in ACQ-5 at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI
Time frame: at weeks 2, 4 and 8 from baseline
Proportion of patients treated with BGF MDI who achieve the MCID in global Mini AQLQ score
To evaluate proportion of patients treated with BGF MDI who achieve the MCID in global Mini AQLQ score at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI
Time frame: at weeks 2, 4, 8 from baseline
Onset of action of BGF MDI measured by the Onset of Effect Questionnaire (OEQ)
To evaluate the onset of action of BGF MDI measured by the Onset of Effect Questionnaire (OEQ) at 5 and 30 minutes after the first administration
Time frame: 5 and 30 minutes after the first administration
Changes in the cough and sputum symptoms measured by Cough And Sputum Assessment Questionnaire (CASA-Q)
To evaluate changes in the cough and sputum symptoms measured by Cough And Sputum Assessment Questionnaire (CASA-Q) at 2, 4 and 8 weeks from baseline in the asthma patients initiated with BGF MDI
Time frame: 2, 4 and 8 weeks from baseline
No study locations are listed for this record.
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 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.
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Aug 2027, 7 months later.
Of 90 industry-sponsored observational studies under Asthma, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 58. This study's planned 7 months is below that.
Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.
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 ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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