Mild AsthmaPhase 4DARWINNCT06563102
Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma
A Phase 4 study testing Albuterol/Budesonide and Albuterol in people with Mild Asthma, run by AstraZeneca at 16 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy and safety of albuterol/budesonide to albuterol in changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma. Study details include: The study duration will be up to 15 weeks. The treatment duration will be 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Mild Asthma
- What is being tested?
- Albuterol/Budesonide and Albuterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 16 sitesUnited States
- Study dates
- 11 Sep 2024to 24 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent
- 1 Capable of giving signed informed consent as described in the protocol which included compliance with the requirements and restrictions listed in the ICF and protocol
- Type of Participant and Disease Characteristics 3 Diagnosis of asthma, by a prescribing health care professional 4 ≥ 2 prescriptions for a SABA inhaler in the past 12 months prior to Visit 1 (and the expectation that the participant will probably use their rescue inhaler ≥ 2 days per week as this is required at Visit 2 for randomization following the Lead-in Period) 5 FeNO ≥ 25 ppb at Visit 1
- Sex and Contraceptive/Barrier Requirements 7 Female participants: Females must be not of childbearing potential or using a form of birth control as defined below:
- Females not of childbearing potential are defined as females who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. The following age-specific requirements apply:
- Females < 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and in the absence of any alternative medical cause, as judged by the investigator.
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- Females ≥ 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
- Female participants of childbearing potential must use a highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control, as defined below, from enrolment throughout the study and until at least 14 days after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
- All females of childbearing potential must have a negative pregnancy test result at Visit 1.
- Females < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and in the absence of any alternative medical cause, as judged by the investigator.
- Highly effective birth control methods are listed below:
- Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- Oral
- Intravaginal
- Transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral
- Injectable
- Implantable
- Intrauterine device or intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Male partner sterilization/vasectomy with documentation of azoospermia prior to the female participant's entry into the study, and this male is the sole partner for that participant. The documentation on male sterility can come from the site personnel's review of participant's medical records, medical examination and/or semen analysis or medical history interview provided by her or her partner.
- 8 Negative pregnancy test (urine) for female participants of childbearing potential at Visit 1.
- Randomization Criteria 5.1.1 at Visit 2 (Week 0)
- Symptoms requiring rescue medication use for a minimum of 2 days per week for the last 14 days during the Lead-in Period (minimum 4 uses total)
- At least 80% overall compliance rate for performing daily FeNO and spirometry assessments and completing the twice-daily asthma symptom and rescue medication use diary during the Lead-in Period.
Who cannot join
- Medical Conditions
- Any significant disease or disorder, or evidence of drug/substance abuse which in the investigator's opinion would pose a risk to participant safety, interfere with the conduct of study, have an impact on the study results, or make it undesirable for the participant to participate in the study.
- Medical history of life-threatening asthma including intubation and intensive care unit admission.
- Medical conditions (other than allergic rhinitis) or medications that will influence FeNO, as judged by the investigator.
- Concurrent respiratory disease: presence of a known pre-existing, clinically important lung condition other than asthma (eg, cystic fibrosis, idiopathic pulmonary fibrosis, pulmonary arterial hypertension, chronic obstructive pulmonary disease).
- Any disease state or procedure that is likely to necessitate the use of oral/systemic corticosteroids during the Treatment Period, other than asthma.
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- Malignancy: a current malignancy or previous history of cancer in remission for less than 12 months prior to Visit 1 (participants with treated localized squamous cell or basal cell carcinoma of the skin will not be excluded, whereas participants who had melanoma will be excluded). Participants with a history/treatment of malignancy, and which in the investigator's opinion could compromise the safety of the participant.
- Other concurrent medical conditions: participants who have known, pre-existing, clinically significant cardiovascular (including clinically significant cardiac arrhythmia and participants with known QT interval corrected for heart rate using the Fridericia formula > 480 ms), endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
- Current smokers: previous smokers are allowed to be included provided that they stopped smoking > 12 months prior to Visit 1 AND have a smoking history of ≤ 10 pack-years (includes tobacco, e-cigarettes, vapes, marijuana, etc.).
- Alcohol/substance abuse: a history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
- Prior/Concomitant Therapy
- Use of ICS-containing therapy for maintenance or rescue at enrolment. Other therapies for maintenance of asthma control are allowed (leukotriene receptor antagonists and/or antihistamines, for example), but not LAMA or LABA.
- Use of any systemic or inhaled corticosteroid within 4 weeks of Visit 1
- Planned use of a nebulizer during the study (between Visits 1 and 5)
- Prior/Concurrent Clinical Study Experience
- Participation in another clinical study with any marketed or investigational anti-allergic or immunosuppressant biologic drug within 4 months or 5 half-lives (whichever is longer) prior to Visit 1.
- Participation in another clinical study with a non-biologic investigational product or new formulation of a marketed non-biologic drug during the last 30 days prior to Visit 1.
- Other Exclusions
- Participants with a known hypersensitivity to the study drugs or any of the excipients of the products.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Previous randomization in the present study.
- For women only: currently pregnant (confirmed with positive pregnancy test), breastfeeding or planned pregnancy during the study.
- Planned hospitalization during the study that would interfere with study objectives as judged by the investigator.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Research Site
Boise, Idaho, 83706
Research Site
Cape Coral, Florida, 33990
Research Site
Columbus, Georgia, 31904
Research Site
El Paso, Texas, 79903
Research Site
Houston, Texas, 77030
Research Site
Lake Worth, Florida, 33462
Research Site
Lancaster, California, 93534
Research Site
North Charleston, South Carolina, 29420
Research Site
Oklahoma City, Oklahoma, 73120
Research Site
Phoenix, Arizona, 85040
Research Site
Plainfield, Indiana, 46168
Research Site
Riverdale, New Jersey, 07457
Research Site
San Diego, California, 92123
Research Site
St Louis, Missouri, 63141
Research Site
Tucson, Arizona, 85715
Research Site
Waco, Texas, 76712
About this study
Official title: A 12-week, Randomized, Double-Blind, Phase 4 Study Evaluating the Effect of AIRSUPRA Compared to Albuterol Administered as Needed on Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization in Adults With Mild Asthma
The purpose of this study is to compare the efficacy and safety of albuterol/budesonide to albuterol in changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma.
Study details include:
- The study duration will be up to 15 weeks.
- The treatment duration will be 12 weeks.
- The visit frequency will be once every 4 weeks, with 3 clinic visits and 2 video calls in total.
Read the detailed description
DARWIN is a randomized, active-comparator, double-blind, parallel-group, Phase IV study evaluating the effect of albuterol/budesonide (AIRSUPRA) compared to albuterol administered as-needed in response to symptoms on changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma.
Approximately 15 sites in the United States of America will enroll adult participants with mild asthma who use albuterol as a rescue inhaler and who do not take ICS as maintenance therapy.
The study will be divided in 2 periods (Lead-in Period and Treatment Period) and the total duration of the study for each participant could be up to 15 weeks, with a visit frequency of once every 4 weeks:
- Lead-In Period: Up to 3 weeks
- Treatment Period: 12 weeks
- Conditions
- Mild Asthma
- Being tested
- Albuterol/Budesonide, Albuterol
- Keywords
- Respiratory Hypersensitivity, Asthma
- Medical subject headings
- Respiratory Hypersensitivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol/BudesonideCombination product
Also called AIRSUPRA, BDA MDI HFA
Oral Inhalation. Rescue medication. Unit dose strength of 80 μg budesonide and 90 μg albuterol per actuation
AlbuterolCombination product
Also called AS MDI
Oral Inhalation. Rescue medication. Unit dose strength of 90μg albuterol per actuation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Participants randomized to receive albuterol/budesonide | Experimental | Participants will be randomized based on Visit 1 FeNO levels (< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy. Receives: Combination Product: Albuterol/Budesonide |
| Group 2 - Participants randomized to receive albuterol | Active comparator | Participants will be randomized based on Visit 1 FeNO levels (< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy. Receives: Combination Product: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to maximum value of daily morning FeNO
Change from baseline to maximum value of daily morning FeNO over 12 weeks of treatment in the albuterol/budesonide group compared to the albuterol group.
Measured: Daily over 12 weeks
Secondary outcomes (5)
Change from baseline in FeNO on high inflammation days
Change from baseline in FeNO on high inflammation days in the albuterol/budesonide group compared to the albuterol group. A high inflammation day is a day in which the FeNO value is ≥ 20 ppb above baseline.
Measured: Daily over 12 weeks
Number of days with high inflammation (annualized rate)
Number of days with high inflammation in the albuterol/budesonide group compared to the albuterol group. A high inflammation day is a day in which the FeNO value is ≥ 20 ppb above baseline.
Measured: Daily over 12 weeks
Number of days with daily morning FeNO measurements ≥ 50 ppb (annualized rate)
Number of days with FeNO >= 50 ppb in the albuterol/budesonide group compared to the albuterol group.
Measured: Daily over 12 weeks
Number of days with daily morning FeNO measurements ≥ 25 ppb (annualized rate)
Number of days with FeNO >= 25 ppb in the albuterol/budesonide group compared to the albuterol group.
Measured: Daily over 12 weeks
Mean absolute difference in daily morning FeNO over 12 weeks of randomized treatment
Mean daily change in FeNO from the median of the individual's daily FeNO measures over 12 weeks in the albuterol/budesonide group compared to the albuterol group.
Measured: Daily over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start11 Sep 2024
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At Visit 2 (Week 0), participants who demonstrated ≥ 80% compliance with all at-home study procedures during the last 14 days of the Lead-in Period, and who have used their albuterol rescue inhaler at least 2 days per week during the last 14 days of the Lead-in Period (≥ 4 uses total) will be randomized to continue the study and provided with study drug. Randomization will be stratified by Visit 1 FeNO level (\< 50 ppb / ≥ 50 ppb) and geographic region. Both albuterol/budesonide and albuterol will be supplied in identical inhalers and the maximum daily dose is the same for the 2 IMPs (6 doses, ie, 12 inhalations/day).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563102
- Sponsor's protocol ID
- D6930C00018
- Acronym
- DARWIN
- Status last verified
- Feb 2026
- First submitted
- 19 Aug 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 approved.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Randomized, Double-Blind, Phase 4 Study Evaluating the Effect of AIRSUPRA Compared to Albuterol Administered as Needed on Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization in Adults With Mild Asthma
- ClinicalTrials.gov ID
- NCT06563102
- Acronym / sponsor ID
- DARWIN / D6930C00018
- Conditions
- Mild Asthma
- Keywords
- Respiratory Hypersensitivity, Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of albuterol/budesonide to albuterol in changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma.
Study details include:
- The study duration will be up to 15 weeks.
- The treatment duration will be 12 weeks.
- The visit frequency will be once every 4 weeks, with 3 clinic visits and 2 video calls in total.
Detailed description
DARWIN is a randomized, active-comparator, double-blind, parallel-group, Phase IV study evaluating the effect of albuterol/budesonide (AIRSUPRA) compared to albuterol administered as-needed in response to symptoms on changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma.
Approximately 15 sites in the United States of America will enroll adult participants with mild asthma who use albuterol as a rescue inhaler and who do not take ICS as maintenance therapy.
The study will be divided in 2 periods (Lead-in Period and Treatment Period) and the total duration of the study for each participant could be up to 15 weeks, with a visit frequency of once every 4 weeks:
- Lead-In Period: Up to 3 weeks
- Treatment Period: 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- At Visit 2 (Week 0), participants who demonstrated ≥ 80% compliance with all at-home study procedures during the last 14 days of the Lead-in Period, and who have used their albuterol rescue inhaler at least 2 days per week during the last 14 days of the Lead-in Period (≥ 4 uses total) will be randomized to continue the study and provided with study drug. Randomization will be stratified by Visit 1 FeNO level (< 50 ppb / ≥ 50 ppb) and geographic region. Both albuterol/budesonide and albuterol will be supplied in identical inhalers and the maximum daily dose is the same for the 2 IMPs (6 doses, ie, 12 inhalations/day).
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Participants randomized to receive albuterol/budesonide | Experimental | Combination Product: Albuterol/BudesonideParticipants will be randomized based on Visit 1 FeNO levels (< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy. |
| Group 2 - Participants randomized to receive albuterol | Active comparator | Combination Product: AlbuterolParticipants will be randomized based on Visit 1 FeNO levels (< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Informed Consent
- 1 Capable of giving signed informed consent as described in the protocol which included compliance with the requirements and restrictions listed in the ICF and protocol
- Type of Participant and Disease Characteristics 3 Diagnosis of asthma, by a prescribing health care professional 4 ≥ 2 prescriptions for a SABA inhaler in the past 12 months prior to Visit 1 (and the expectation that the participant will probably use their rescue inhaler ≥ 2 days per week as this is required at Visit 2 for randomization following the Lead-in Period) 5 FeNO ≥ 25 ppb at Visit 1
- Sex and Contraceptive/Barrier Requirements 7 Female participants: Females must be not of childbearing potential or using a form of birth control as defined below:
- Females not of childbearing potential are defined as females who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. The following age-specific requirements apply:
Key exclusion criteria (23 listed)
- Medical Conditions
- Any significant disease or disorder, or evidence of drug/substance abuse which in the investigator's opinion would pose a risk to participant safety, interfere with the conduct of study, have an impact on the study results, or make it undesirable for the participant to participate in the study.
- Medical history of life-threatening asthma including intubation and intensive care unit admission.
- Medical conditions (other than allergic rhinitis) or medications that will influence FeNO, as judged by the investigator.
- Concurrent respiratory disease: presence of a known pre-existing, clinically important lung condition other than asthma (eg, cystic fibrosis, idiopathic pulmonary fibrosis, pulmonary arterial hypertension, chronic obstructive pulmonary disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuterol/BudesonideAlso: AIRSUPRA, BDA MDI HFAOral Inhalation. Rescue medication. Unit dose strength of 80 μg budesonide and 90 μg albuterol per actuation | Combination product | Group 1 - Participants randomized to receive albuterol/budesonide |
| AlbuterolAlso: AS MDIOral Inhalation. Rescue medication. Unit dose strength of 90μg albuterol per actuation. | Combination product | Group 2 - Participants randomized to receive albuterol |
Primary outcome
Change from baseline to maximum value of daily morning FeNO
Time frame: Daily over 12 weeks
Change from baseline to maximum value of daily morning FeNO over 12 weeks of treatment in the albuterol/budesonide group compared to the albuterol group.
5 secondary outcomes
Change from baseline in FeNO on high inflammation days
Time frame: Daily over 12 weeks
Number of days with high inflammation (annualized rate)
Time frame: Daily over 12 weeks
Number of days with daily morning FeNO measurements ≥ 50 ppb (annualized rate)
Time frame: Daily over 12 weeks
Number of days with daily morning FeNO measurements ≥ 25 ppb (annualized rate)
Time frame: Daily over 12 weeks
Mean absolute difference in daily morning FeNO over 12 weeks of randomized treatment
Time frame: Daily over 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: 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 approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Albuterol/Budesonide and Albuterol in people with Mild Asthma, run by AstraZeneca at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to maximum value of daily morning FeNO (time frame: Daily over 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.