An observational study in Asthma, sponsored by AstraZeneca. Completed at 175 sites in 2 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by AstraZeneca · Observational
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Among 359 studies in Asthma by AstraZeneca — 19 open to participants now, 28 under way, 8 of them phase 3. Asthma · AstraZeneca.
Among the 359 studies in Asthma by AstraZeneca, this one is the 109th largest by enrollment of the 110 observational ones that give a count, is one of 8 that started in 2018, is one of 111 observational ones, and was the 229th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →19 of the 359 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; 147 take children under 18; 105 take healthy volunteers.
This study: 18 Years to 130 Years · 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.
359 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 3 123 · Phase 4 23
First in 1996; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 159 across 1,252 observational studies indexed under Asthma.
Median enrollment 175 across the 248 interventional studies, 500 across the 110 observational. Of the 330 that completed or were terminated, 129 (39%) have results posted.
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AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 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 |
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Among the 359 studies in Asthma by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The CHRONICLE Study is a multi-center, non-interventional, prospective cohort study of adults with severe asthma who do not achieve control with high-dose inhaled corticosteroid (ICS) therapy with additional controllers and/or require systemic corticosteroid or monoclonal antibody therapy. Data will be collected from the healthcare provider in a uniform manner for every patient enrolled using an electronic case report form (eCRF). Data will be collected monthly from patients via web-based surveys. Patients will be followed until study discontinuation or the patient withdraws from the study or death, whichever occurs first. The expectation is that patients will be followed for a period of at least 3 years.
The CHRONICLE Study is a multi-center, non-interventional, prospective cohort study of adults with severe asthma who do not achieve control with high-dose ICS therapy with additional controllers and/or require systemic corticosteroid or monoclonal antibody therapy. This study will provide a contemporary description of the epidemiology and medical management of United States adults with severe asthma who have not achieved control with high-dose ICS therapy and additional controllers. Additionally, the study will describe the use of and outcomes associated with recently approved monoclonal antibody therapies for severe asthma. Patients will be enrolled from a diverse population of academic and community-based specialist centers across the US. Data will be collected in a naturalistic manner and patient management will not be influenced by the study protocol. At least 1500 patients in the US with a confirmed diagnosis of severe asthma will be enrolled by a diverse set of asthma specialists (eg, allergists and pulmonologists who treat asthma) from academic and community-based centers. Basic de-identified information will be collected for all patients meeting study inclusion criteria, including those not approached for enrollment or who decline enrollment, to enable an assessment of the enrolled and non-enrolled populations. This information will include age, sex, insurance status, age at asthma diagnosis, class of asthma treatment per study inclusion criteria, number of asthma exacerbations in the past 12 months, study eligibility, whether the patient was approached for enrollment, study enrollment status, and reason for not enrolling for those who are approached but do not enroll. Patient-reported asthma control (Asthma Control Test [ACT]), asthma exacerbations, and treatment adherence will be solicited monthly. Patient-reported information on asthma-related healthcare utilization, global evaluation of treatment effectiveness (GETE), and work productivity (Work Productivity and Activity Impairment Asthma questionnaire [WPAI-Asthma]) will be collected at baseline and approximately every 3 months. Detailed information on asthma-related quality of life (Saint George's Respiratory Questionnaire [SGRQ]) as well as presence of an asthma treatment plan will be collected from patients approximately every 6 months. All of the questionnaires will be collected via web-based surveys. Patients will then be followed until study discontinuation or the patient withdraws from the study or death, whichever occurs first. The expectation is that patients will be followed for a period of at least 3 years.
It is estimated that at least 1500 patients in the US with a confirmed diagnosis of severe asthma will be enrolled by a diverse set of asthma specialists (eg, allergists and pulmonologists who treat asthma) from academic and community-based centers.
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.
1. Individuals with a diagnosis of severe asthma for at least 12 months prior to enrollment and confirmed by the Investigator not to be due to alternative diagnoses.
2. Currently receiving care from specialist physicians (eg, pulmonologists and or allergists) at the Investigator's or sub-investigator's site.
3. 18 years of age and older. 4. Meeting at least one of the following three criteria (a, b, or c):
a. Uncontrolled asthma while receiving high-dose ICS with additional controllers.
i. Uncontrolled is defined by meeting at least one of the following (as outlined by ATS/ERS [American Thoracic Society/European Respiratory Society] guidelines):
ii. For the purposes of this study, high-dose ICS will be defined as
1. ICS at a cumulative dose of >500 μg fluticasone propionate equivalents daily as defined in Appendix A, or 2. Highest labeled dose of a combination of ICS/LABA. b. Current use of a Food and Drug Administration (FDA)-approved monoclonal antibody agent for treatment of severe asthma (use is not primarily for an alternative condition).
c. Use of systemic corticosteroids or other systemic (any dose level) for approximately 50% or more of the prior 12 months for treatment of severe asthma (use is not primarily for an alternative condition).
Exclusion Criteria
Received an therapy for asthma, allergy, atopic disease, or eosinophilic disease as part of a clinical trial during the 6 months prior to enrollment.
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.
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.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To describe patient characteristics, treatment patterns, and health outcomes among a large, geographically diverse cohort of US adults with severe asthma who are not controlled on high-dose ICS with additional controllers and/or require chronic systemic corticosteroid or monoclonal antibody therapy.
Healthcare utilization- hospitalizations, clinic Visits, and asthma exacerbations
Longitudinal changes of Healthcare utilization will be measured using directly collected information from medical, hospital, and pharmacy records to provide a supplementary comprehensive assessment of each patient's healthcare utilization during the study period.
Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.
Asthma treatment
Asthma medications with dose and start/stop dates including all FDA-approved and standard of care treatments for asthma will be assessed. Longitudinal changes in asthma treatment will also be assessed.
Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.
Treatment adherence
Extraction of electronic medical, hospital, and pharmacy records will take place at study close and potentially at interim time points to provide a supplementary assessment of each patient's healthcare resource utilization. Longitudinal changes in patient reported treatment adherence will also be assessed.
Time frame: At baseline, every 1 month, through study completion, assessed up to 7 years.
Asthma control test (ACT)
Patient-reported asthma symptoms and control will be collected via the ACT questionnaire; a 5 item, self-administered survey that is designed to help the patient describe their asthma and how it affects their daily activities. ACT questionnaire is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). In 2022, the ACT survey will be removed, and only the AIRQ will be solicited monthly.
Time frame: Change from baseline, every 1 month, through study completion, assessed up to 4 years.
Patient-reported asthma exacerbations
Asthma exacerbations, the primary analytical definition will be worsening of asthma that leads to any of the following: Use of systemic corticosteroids (or a temporary increase in a stable corticosteroid background dose) for at least 3 days; a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids. An emergency department or urgent care visit (defined as evaluation and treatment for \<24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids. An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. In 2022, the asthma exacerbations survey will be removed, and only the AIRQ will be solicited monthly.
Time frame: Change from baseline, every 1 month, through study completion, assessed up to 4 years.
Asthma Impairment and Risk Questionnaire (AIRQ)
AIRQ is a 10-item, equally weighted, yes/no composite asthma control questionnaire that includes 7 impairment and 3 risk items. AIRQ scores range from 0 to 10, with lower scores representing better controlled asthma.
Time frame: At baseline, every 1 month, through study completion, assessed up to 4 years
Work Productivity and Activity Impairment Asthma questionnaire (WPAI-Asthma)
Patient-reported productivity impairment assessment including work productivity, activity impairment, and disability will be collected via the WPAI-Asthma. Information will only be collected from procedures that are part of the patient's routine clinical care. WPAI Asthma questionnaire is calculated from 0 to 10 score (0 indicates-Asthma had no effect on my work/ daily activities and 10 indicates Asthma completely prevented me from working score/ doing my daily activities).
Time frame: At baseline, every 3 months, through study completion, assessed up to 7 years.
St. George's Respiratory Questionnaire (SGRQ)
Patient-reported assessment of asthma quality of life will be collected via the SGRQ. SGRQ, a disease specific health-related quality of life measure developed for both asthma and chronic obstructive pulmonary disease (COPD) patients. The SGRQ has 50 items and scores are calculated for 3 domains (symptoms, activity, and impact \[psychosocial\]) as well as total score. Symptoms - this component is concerned with the effect of respiratory symptoms, their frequency and severity. Impacts (psychosocial) - covers a range of aspects concerned with social functioning and psychological disturbances resulting from respiratory disease Activity - concerned with activities that cause or are limited by breathlessness. Total score summarizes the impact of the disease on overall health status. The score is expressed as a percentage of overall impairment, where 100 represents worst possible health status and 0 indicates best possible health status.
Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.
Global evaluation of treatment effectiveness (GETE)
Patient evaluation of asthma treatment effectiveness will be measured using GETE; a simple measure of perceived treatment effectiveness. The patient will grade the overall treatment effectiveness using the following criteria: excellent (complete control of asthma); good (marked improvement of asthma); moderate (discernible, but limited improvement in asthma); poor (no appreciable change in asthma); or worsening (of asthma).
Time frame: At baseline, every 6 months, through study completion, assessed maximum up to 7 years.
Number of Participants With Adverse Events associated with corticosteroid therapy
Frequency of relevant medical events such as weight gain (change in BMI), hypertension, dyslipidemia, pneumonia, bone densitometry results, osteoporosis / osteopenia, hip and spinal fractures, avascular necrosis, cataract, glaucoma, diabetes mellitus, cardiovascular disease, Cushing's syndrome, adrenal insufficiency, peptic ulcer disease, myopathy, pseudotumor cerebri, mood disturbance, and insomnia or sleep disturbance.
Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.
Relevant respiratory medical events
Frequency of relevant respiratory medical events such as pneumonia, pleural effusion, chronic bronchitis, allergic rhinitis.
Time frame: At baseline, every 6 months, through study completion,assessed up to 7 years.
Respiratory comorbidities
Prevalence of respiratory comorbidities such as chronic obstructive pulmonary disease (COPD), bronchiectasis, alpha-1 anti-trypsin deficiency, Churg- Strauss syndrome (eosinophilic granulomatosis with polyangiitis \[EGPA\]), airway stenosis, cystic fibrosis, allergic bronchopulmonary aspergillosis,chronic eosinophilic pneumonia, bronchiolitis obliterans, immunodeficiency, primary ciliary dyskinesia, atelectasis, arterial hypertension, pulmonary hypertension, neuromuscular disease, allergic rhinitis, chronic rhinosinusitis, and pulmonary embolism.
Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.
Non-respiratory comorbidities
Prevalence of non-respiratory comorbidities such as diabetes, thyroid disease, cardiac disease, etc.
Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.
Events of special interest
Frequency of special interest events including new onset malignancy, severe infection, anaphylaxis, or mortality.
Time frame: At baseline, every 6 months, through study completion, assessed up to 7 years.
Complete blood count with differential including blood eosinophil count.
To assess complete blood count with differential including blood eosinophil count as a variable for asthma evaluation.
Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.
Total immunoglobulin E (IgE)
To assess total IgE as a variable for asthma evaluation.
Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.
Radiographic changes in asthma evaluation.
Radiographic changes in asthma evaluation included chest X-rays (dates, views, description of major chest findings), Chest computed tomography scan (dates, high resolution (yes/no), intravenous contrast (yes/no), description of major findings). Radiographic asthma evaluation conducted as part of routine care.
Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.
Forced Vital Capacity (FVC)
FEV1 (liters and % predicted) will be assessed as a variable for asthma evaluation.
Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.
Forced Expiratory Volume in 1 second (FEV1)
FEV1 (liters and % predicted) will be assessed as a variable for asthma evaluation.
Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.
Fractional exhaled nitric oxide (FENO)
To assess FENO as a variable for asthma evaluation.
Time frame: Change from baseline, every 6 months, through study completion, assessed up to 7 years.
Showing the first 100 of 175 sites across 2 countries. Choose a country and city above to see the rest.
Plan to share: No
Ran from Feb 2018 to primary completion in Feb 2025, 83 months.
Of 90 industry-sponsored observational studies under Asthma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 58. This study's 83 months is above that.
Counting every sponsor, half of 455 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.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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