AsthmaPhase 2APATURANCT04643158
Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids
A Phase 2 study testing AZD1402, Short acting beta agonist (SABA) (rescue medication) and Run-in medications (ICS-LABA combination) in people with Asthma, run by AstraZeneca at 40 sites in 10 countries.
Trial summary
This is a randomised, placebo-controlled, double-blinded, multi-centre, 2-part study to assess the efficacy and safety of inhaled AZD1402. Part 1 will be performed in a Lead-in Cohort for each dose level to evaluate the safety and pharmacokinetics (PK) in a population with asthma controlled on medium dose inhaled… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- AZD1402, Short acting beta agonist (SABA) (rescue medication) and Run-in medications (ICS-LABA combination)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 40 sitesin 10 countries
- Study dates
- 12 Mar 2021to 20 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have a documented clinical diagnosis of asthma for ≥ 12 months before Visit 1.
- Participants who are able to perform acceptable pulmonary function testing for FEV1.
- Participants who are able to demonstrate the ability to use the study inhalation device properly.
- Male participants must be surgically sterile or agree to use highly-effective contraceptives.
- All female participants must have a negative serum pregnancy test at Screening. Female participants of non-childbearing potential, Female participants of childbearing potential must have a negative urine pregnancy test before the administration of first dose of study intervention and must agree to use a highly-effective method of birth control.
- Participant is a non smoker or an ex-smoker with a total smoking history of less than 10 pack-years.
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- Only for Part 1: Documented treatment with medium dose ICS with LABA for at least 6 months prior to Screening. ICS and LABA must be on a stable dose for at least 3 months prior to Screening, during Screening and Run-in Periods and may be contained in a combination product or separate inhaler. No asthma exacerbations in last 12 months requiring oral or intravenous (IV) steroids or hospitalisation/ emergency room visit due to asthma. Pre-bronchodilator FEV1 ≥ 70% predicted at Screening and start of Run-in. Asthma Control Questionnaire 6 score of ≤ 1.0 at Screening and start of Run-in.
- Only for Part 2: Documented evidence of asthma. Documented treatment with medium-to-high dose ICS-LABA for at least 6 months prior to Screening. ICS and LABA must be on a stable dose for at least 4 weeks prior to Screening, during Screening and Run-in Periods. If on asthma maintenance controller medications in addition to ICS-LABA, the dose of the additional controller medications must be stable for at least 4 weeks prior to Screening, during Screening and Run-in Periods. Pre bronchodilator FEV1 of 40% to 85% (inclusive) predicted at Screening and start of Run-in. Blood eosinophil count of ≥ 150 cells/μL and FeNO ≥ 25 ppb at Screening. Asthma Control Questionnaire 6 score ≥ 1.5 at Screening.
- Specific Randomisation Criteria at Visit 3
- For Part 1: Pre-bronchodilator FEV1 ≥ 70% predicted. At least 70% compliance with usual asthma controller ICS-LABA during Run-in Period (from Visit 2 to Visit 3) based on daily electronic diary (e-Diary). Minimum 80% compliance with ePRO completion. Asthma Control Questionnaire 6 score of ≤ 1.0. C-reactive protein < 5 mg/L on Day -1.
- For Part 2: Pre-bronchodilator FEV1 of 40% to 85% (inclusive) predicted. Asthma Control Questionnaire 6 score of ≥ 1.5. At least 70% compliance with usual asthma controller ICS-LABA during Run-in Period from (Visit 2 to Visit 3) based on daily e-Diary. Minimum 70% compliance with ePRO completion. C-reactive protein < 10 mg/L at Visit 2. A FeNO of ≥ 25 ppb.
Who cannot join
- Women who are pregnant or breastfeeding, or who are planning to become pregnant during the study.
- Known or suspected hypersensitivity including anaphylaxis/anaphylactoid reaction following any biologic therapy, or known history of drug hypersensitivity to any component of the study intervention formulation.
- Evidence of any active clinically important pulmonary disease other than asthma, within 5 years at screening.
- History of pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts.
- History or clinical suspicion of any clinically relevant or active disease or disorder.
- History of severe COVID-19 infection requiring hospitalisation within the last 12 months or clinical history compatible with long COVID (symptoms beyond 12 weeks of acute infection).
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- Confirmed symptomatic COVID-19 infection during Screening, Run-in or prior to randomisation.
- Current malignancy or history of malignancy.
- Significant history of recurrent or ongoing 'dry eye'.
- Diagnosis of Sjögren's syndrome.
- High risk of infection suggesting abnormal immune function.
- History of, or known significant infection or positivity at Screening period, including hepatitis B or C, or human immunodeficiency virus (HIV).
- Evidence of active tuberculosis.
- Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to Screening and during Run-in.
- Clinically significant upper respiratory tract infection at Screening and during Run-in.
- A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained.
- Any clinically important ECG abnormalities.
- Any clinically significant cardiac disease.
- Uncontrolled hypertension.
- History of life-threatening asthma attack or asthma attack requiring ventilation.
- Part 2 only: History of 3 or more severe asthma exacerbations.
- Daily rescue use of SABA ≥ 8 puffs for ≥ 3 consecutive days at any time during Run-in Period, before randomisation.
- History of anaphylaxis.
- Any clinically significant abnormalities in haematology.
- Alanine aminotransferase or AST level ≥ 3 times the upper limit of normal (ULN), confirmed by repeated testing during Screening Period.
- History of, drug or alcohol abuse within the past 2 years prior to Screening.
- Planned in-patient surgery, major dental procedure or hospitalisation during the study.
- Prior/Concomitant Therapy: Systemic corticosteroid use, AZD1402, marketed or investigational biologicals such as monoclonal antibodies or chimeric biomolecules, investigational nonbiologic drug within 60 days prior to Screening and during Run-in, any immunosuppressive therapy, Live or attenuated vaccine within 4 weeks of Screening and during Run-in, Receipt of COVID-19 vaccine (vaccine or booster dose) within 30 days prior to randomisation, Immunoglobulin or blood products within 4 weeks of Screening and during Run-in, Any immunotherapy within 3 months of Screening and during Run-in.
- Part 1 only: Additional asthma maintenance controller medications in addition to ICS-LABA (eg, leukotriene receptor inhibitors, theophylline, LAMA, chromones) within 3 months of Screening period and during Run-in.
Trial locations and contacts
40 sites in 10 countries.
40 sites in 10 countries
Germany9 sites
Research Site
Berlin, 10119
Research Site
Berlin, 10625
Research Site
Berlin, 10717
Research Site
Berlin, 14050
Research Site
Bonn, 53119
Research Site
Frankfurt, 60596
Research Site
Hamburg, 20354
Research Site
Hanover, D-30173
Research Site
Lübeck, 23552
South Korea8 sites
Research Site
Cheongiu, 28644
Research Site
Incheon, 21431
Research Site
Namdong-gu, 21565
Research Site
Seoul, 02841
Research Site
Seoul, 03312
Research Site
Seoul, 06591
Research Site
Seoul, 08308
Research Site
Suwon, 16499
Poland7 sites
Research Site
Bialystok, 15-044
Research Site
Krakow, 30-033
Research Site
Krakow, 31-501
Research Site
Lodz, 90-302
Research Site
Lubin, 59-300
Research Site
Sopot, 81-741
Research Site
Wroclaw, 53-301
United Kingdom4 sites
Research Site
High Wycombe, HP11 2QW
Research Site
Liverpool, L7 8XP
Research Site
London, SE1 9RT
Research Site
London, W1G 8HU
Australia3 sites
Research Site
Herston, 4006
Research Site
Melbourne, IC 3004
Research Site
Nedlands, 6009
Spain3 sites
Research Site
Barcelona, 08916
Research Site
Santiago de Compostela, 15706
Research Site
Villarreal, 12540
Canada2 sites
Research Site
Québec, Quebec, G1G 4A2
Research Site
Windsor, Ontario, N8X 1T3
About this study
Official title: A Two-part Phase IIa Randomised, Double-blind, Placebo-controlled, Dose-ranging, Multi-centre Study to Assess Efficacy and Safety of Inhaled AZD1402 Administered as a Dry Powder for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids
This is a randomised, placebo-controlled, double-blinded, multi-centre, 2-part study to assess the efficacy and safety of inhaled AZD1402. Part 1 will be performed in a Lead-in Cohort for each dose level to evaluate the safety and pharmacokinetics (PK) in a population with asthma controlled on medium dose inhaled corticosteroids (ICS)-long acting beta agonists (LABA) before progressing to dosing in adults with asthma who are uncontrolled on medium-to-high dose ICS-LABA in Part 2. The study will recruit participants receiving treatment with medium dose ICS with LABA for Part 1 and participants receiving treatment with medium-to-high dose ICS with LABA for Part 2 (separate inhalers or combination product).
Part 2 will be initiated following evaluation of safety and PK at the relevant dose level in Part 1a. The entire study period for each participant in both Parts 1 and 2, is approximately 3.5 months; a 2-week Screening Period, a 4 week Run-in Period, 4 weeks of Treatment Period, and 4 weeks of Follow-Up Period.
Read the detailed description
Part 1 of the study will be randomised, double blind, placebo-controlled, and conducted in parallel for the 2 lower dose levels (Part 1a) followed by an unblinded safety review and escalation to the highest dose (Part 1b) dependent on the outcome of the safety review.
Part 1a will consist of 30 participants who will be randomised 1:1:1 to receive 1 of the 2 lower AZD1402 dry power inhaler (DPI) doses (Dose 1 or Dose 2) or placebo in parallel. Part 1b will consist of 15 participants who will be randomised 2:1 to receive the highest AZD1402 DPI dose (Dose 3) or placebo.
Part 1a Lead-in Cohort
- AZD1402 Dose 1
- AZD1402 Dose 2
- Placebo
Part 1b Lead-in Cohort
- AZD1402 Dose 3
- Placebo
Part 2 will be randomised, double blind, placebo controlled and will include approximately 165 participants randomised 2:1 (active to placebo) to evaluate 2 inhaled dose levels of AZD1402 versus placebo.
Part 2 will be started after the unblinded safety review for Part 1a. Part 2 will include:
- AZD1402 Dose 1
- AZD1402 Dose 2
- Placebo
- Conditions
- Asthma
- Being tested
- AZD1402, Placebo, Short acting beta agonist (SABA) (rescue medication), Run-in medications (ICS-LABA combination)
- Keywords
- AZD1402, placebo, Anticalin® protein, dry powder inhaler, inhaled corticosteroids, efficacy, safety
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1402Drug
Randomised participants will receive oral inhalation of AZD1402, via DPI.
PlaceboDrug
Randomised participants will receive oral inhalation of matching placebo via DPI.
Short acting beta agonist (SABA) (rescue medication)Drug
In addition to study intervention, all participants will be provided with a SABA as rescue medication (eg, salbutamol/albuterol), to be used throughout the Run-in and Treatment Periods. All participants should refrain from taking a SABA as rescue medication 6 hours prior to pulmonary function tests.
Dosage levels: 100 μg per nominal dose 90 μg per nominal dose pro re nata (as required) (PRN)
Run-in medications (ICS-LABA combination)Drug
During the Run-in Period, the participants are required to maintain on their ICS-LABA dose. Controller medications (eg, ICS LABA) should remain at a stable dose and be taken after study intervention as applicable.
These drugs are used as standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 and Part 2: AZD1402 Dose 1 | Experimental | Randomised participants will receive oral inhalation of AZD1402 Dose 1 via DPI. Receives: Drug: AZD1402; Drug: Short acting beta agonist (SABA) (rescue medication); Drug: Run-in medications (ICS-LABA combination) |
| Part 1 and Part 2: AZD1402 Dose 2 | Experimental | Randomised participants will receive oral inhalation of AZD1402 Dose 2 via DPI. Receives: Drug: AZD1402; Drug: Short acting beta agonist (SABA) (rescue medication); Drug: Run-in medications (ICS-LABA combination) |
| Part 1: AZD1402 Dose 3 | Experimental | Randomised participants will receive oral inhalation of AZD1402 Dose 3 via DPI. Receives: Drug: AZD1402; Drug: Short acting beta agonist (SABA) (rescue medication); Drug: Run-in medications (ICS-LABA combination) |
| Part 1 and Part 2: Placebo | Placebo comparator | Randomised participants will receive oral inhalation of matching placebo via DPI. Receives: Drug: Placebo; Drug: Short acting beta agonist (SABA) (rescue medication); Drug: Run-in medications (ICS-LABA combination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Adverse Events (AEs)
The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.
Measured: From Screening (Week -6) until Follow-up (Day 56)
Part 2: Change From Baseline in Pre-bronchodilator FEV1
The efficacy of inhaled AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was investigated.
Measured: Baseline and Week 4
Part 1: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.
Measured: Baseline, Day 12, Day 16, and Day 56
Part 1: Change From Baseline in FEV1 In-clinic Spirometry
The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.
Measured: Baseline, Day 1, Day 7, Day 14, Day 28, and Day 56
Part 1: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) (In-clinic)
The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.
Measured: Baseline, Day 1, Day 7, Day 14, Day 28, and Day 56
Secondary outcomes (21)
Part 1 and Part 2: Antidrug Antibodies (ADA) Titers
ADA-positive samples were tested to investigate the immunogenicity of AZD1402.
Measured: Day 1 until Day 56
Part 1 and Part 2: Maximum Observed Serum (Peak) Drug Concentration (Cmax)
The pharmacokinetic (PK) profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 1 and Part 2: Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz)
The PK profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 1 and Part 2: Area Under Plasma Concentration-time Curve in the Dosing Interval τ (AUCτ)
The PK profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 1 and Part 2: Area Under the Plasma Concentration-curve From Zero to the Last Quantifiable Concentration (AUClast)
The PK profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 1 and Part 2: Observed Lowest Drug Concentration Reached Before the Next Dose is Administered (Pre-dose) (Ctrough)
The PK profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 1 and Part 2: Terminal Rate Constant, Estimated by Log-linear Least Squares Regression of the Terminal Part of the Concentration-time Curve (λz)
The PK profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 1 and Part 2: Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on Terminal Phase) (Vz/F)
The PK profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 1 and Part 2: Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F)
The PK profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 1 and Part 2: Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax)
The PK profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 1 and Part 2: Time of Last Observed (Quantifiable) Concentration (Tlast)
The PK profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 1 and Part 2: Accumulation Ratio for AUCτ (Rac AUC)
The PK profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 1 and Part 2: Accumulation Ratio for Cmax (Rac Cmax)
The PK profile of AZD1402 was investigated.
Measured: Day 1 until Day 56
Part 2: Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) at Week 4 and Average Over the Treatment Period
The efficacy of AZD1402 compared to placebo in adults with asthma who are uncontrolled on medium-to-high dose ICS-LABA was further investigated. The ACQ was developed to measure asthma control. In the ACQ-6, participants were asked to recall how their asthma had been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated a worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful.
Measured: Baseline, Week 4
Part 2: Participants With a Decrease in ACQ 6 Score of ≥ 0.5 From Baseline to Week 4
The efficacy of AZD1402 compared to placebo in adults with asthma who are uncontrolled on medium-to-high dose ICS-LABA was further investigated. The ACQ was developed to measure asthma control. In the ACQ-6, participants were asked to recall how their asthma had been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated a worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful.
Measured: Baseline, Week 4
Part 2: Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the Treatment Period
The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated. Peak expiratory flow was measured by the participants at home using a peak flow meter.
Measured: Baseline, 4 weeks
Part 2: Change From Baseline in Average Evening PEF Over the Treatment Period
The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated. Peak expiratory flow was measured by the participants at home using a peak flow meter.
Measured: Baseline, 4 weeks
Part 2: Change From Baseline in Daily Average Asthma Symptom Score (AM/PM) Over the Treatment Period
The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated. Severity scores for asthma symptoms were recorded twice daily in the morning and evening and documented in an e-Diary. Asthma symptom scores during night-time and day-time were assessed by the participant each morning and evening according to the following scoring system: 0: You have no asthma symptoms. 1: You are aware of your asthma symptoms but you can easily tolerate the symptoms. 2: Your asthma is causing you enough discomfort to cause problems with normal activities (or with sleep). 3: You are unable to do your normal activities (or to sleep) because of your asthma. Higher scores indicated worse outcome.
Measured: Baseline, 4 weeks
Part 2: Change From Baseline in Pre-bronchodilator FEV1 Average Over the 4-week Treatment Period
The efficacy of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was further investigated.
Measured: Baseline and Week 4
Part 2: Change From Baseline in FeNO (In-clinic) at Week 4 and Average Over the Treatment Period
The effect of AZD1402 compared to placebo on airway inflammation in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was investigated. To investigate the effect of AZD1402 on airway inflammation, the measurement of FeNO was performed in accordance with ATS/ERS guidelines. Standardised conditions with regard to exhalation flow rate and duration of exhalation were followed such that plateau definition could be evaluated over a minimum of 3 seconds.
Measured: Baseline, Week 4
Part 2: Number of Participants With Adverse Events (AEs)
The safety and tolerability of AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was evaluated.
Measured: From Screening (Week -6) until Follow-up (Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start12 Mar 2021
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Why it stopped: The decision was based on lung findings from a non-clinical 13-week Good Laboratory Practice (GLP) toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643158
- Sponsor's protocol ID
- D2912C00003
- Other IDs
- 2020-002828-37
- Acronym
- APATURA
- Status last verified
- Aug 2025
- First submitted
- 23 Nov 2020
- Last updated
- 28 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- 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. 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Phase IIa Randomised, Double-blind, Placebo-controlled, Dose-ranging, Multi-centre Study to Assess Efficacy and Safety of Inhaled AZD1402 Administered as a Dry Powder for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids
- ClinicalTrials.gov ID
- NCT04643158
- Acronym / sponsor ID
- APATURA / D2912C00003
- Conditions
- Asthma
- Keywords
- AZD1402, placebo, Anticalin® protein, dry powder inhaler, inhaled corticosteroids, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision was based on lung findings from a non-clinical 13-week Good Laboratory Practice (GLP) toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.
- Enrolment
- 72 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Posted 28 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised, placebo-controlled, double-blinded, multi-centre, 2-part study to assess the efficacy and safety of inhaled AZD1402. Part 1 will be performed in a Lead-in Cohort for each dose level to evaluate the safety and pharmacokinetics (PK) in a population with asthma controlled on medium dose inhaled corticosteroids (ICS)-long acting beta agonists (LABA) before progressing to dosing in adults with asthma who are uncontrolled on medium-to-high dose ICS-LABA in Part 2. The study will recruit participants receiving treatment with medium dose ICS with LABA for Part 1 and participants receiving treatment with medium-to-high dose ICS with LABA for Part 2 (separate inhalers or combination product).
Part 2 will be initiated following evaluation of safety and PK at the relevant dose level in Part 1a. The entire study period for each participant in both Parts 1 and 2, is approximately 3.5 months; a 2-week Screening Period, a 4 week Run-in Period, 4 weeks of Treatment Period, and 4 weeks of Follow-Up Period.
Detailed description
Part 1 of the study will be randomised, double blind, placebo-controlled, and conducted in parallel for the 2 lower dose levels (Part 1a) followed by an unblinded safety review and escalation to the highest dose (Part 1b) dependent on the outcome of the safety review.
Part 1a will consist of 30 participants who will be randomised 1:1:1 to receive 1 of the 2 lower AZD1402 dry power inhaler (DPI) doses (Dose 1 or Dose 2) or placebo in parallel. Part 1b will consist of 15 participants who will be randomised 2:1 to receive the highest AZD1402 DPI dose (Dose 3) or placebo.
Part 1a Lead-in Cohort
- AZD1402 Dose 1
- AZD1402 Dose 2
- Placebo
Part 1b Lead-in Cohort
- AZD1402 Dose 3
- Placebo
Part 2 will be randomised, double blind, placebo controlled and will include approximately 165 participants randomised 2:1 (active to placebo) to evaluate 2 inhaled dose levels of AZD1402 versus placebo.
Part 2 will be started after the unblinded safety review for Part 1a. Part 2 will include:
- AZD1402 Dose 1
- AZD1402 Dose 2
- Placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 and Part 2: AZD1402 Dose 1 | Experimental | Drug: AZD1402, Drug: Short acting beta agonist (SABA) (rescue medication), Drug: Run-in medications (ICS-LABA combination)Randomised participants will receive oral inhalation of AZD1402 Dose 1 via DPI. |
| Part 1 and Part 2: AZD1402 Dose 2 | Experimental | Drug: AZD1402, Drug: Short acting beta agonist (SABA) (rescue medication), Drug: Run-in medications (ICS-LABA combination)Randomised participants will receive oral inhalation of AZD1402 Dose 2 via DPI. |
| Part 1: AZD1402 Dose 3 | Experimental | Drug: AZD1402, Drug: Short acting beta agonist (SABA) (rescue medication), Drug: Run-in medications (ICS-LABA combination)Randomised participants will receive oral inhalation of AZD1402 Dose 3 via DPI. |
| Part 1 and Part 2: Placebo | Placebo comparator | Drug: Placebo, Drug: Short acting beta agonist (SABA) (rescue medication), Drug: Run-in medications (ICS-LABA combination)Randomised participants will receive oral inhalation of matching placebo via DPI. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants who have a documented clinical diagnosis of asthma for ≥ 12 months before Visit 1.
- Participants who are able to perform acceptable pulmonary function testing for FEV1.
- Participants who are able to demonstrate the ability to use the study inhalation device properly.
- Male participants must be surgically sterile or agree to use highly-effective contraceptives.
- All female participants must have a negative serum pregnancy test at Screening. Female participants of non-childbearing potential, Female participants of childbearing potential must have a negative urine pregnancy test before the administration of first dose of study intervention and must agree to use a highly-effective method of birth control.
Key exclusion criteria (29 listed)
- Women who are pregnant or breastfeeding, or who are planning to become pregnant during the study.
- Known or suspected hypersensitivity including anaphylaxis/anaphylactoid reaction following any biologic therapy, or known history of drug hypersensitivity to any component of the study intervention formulation.
- Evidence of any active clinically important pulmonary disease other than asthma, within 5 years at screening.
- History of pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts.
- History or clinical suspicion of any clinically relevant or active disease or disorder.
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 |
|---|---|---|
| AZD1402Randomised participants will receive oral inhalation of AZD1402, via DPI. | Drug | Part 1 and Part 2: AZD1402 Dose 1, Part 1 and Part 2: AZD1402 Dose 2, Part 1: AZD1402 Dose 3 |
| PlaceboRandomised participants will receive oral inhalation of matching placebo via DPI. | Drug | Part 1 and Part 2: Placebo |
| Short acting beta agonist (SABA) (rescue medication)In addition to study intervention, all participants will be provided with a SABA as rescue medication (eg, salbutamol/albuterol), to be used throughout the Run-in and Treatment Periods. All participants should refrain from taking a SABA as rescue medication 6 hours prior to pulmonary function tests. Dosage levels: 100 μg per nominal dose 90 μg per nominal dose pro re nata (as required) (PRN) | Drug | Part 1 and Part 2: AZD1402 Dose 1, Part 1 and Part 2: AZD1402 Dose 2, Part 1 and Part 2: Placebo, Part 1: AZD1402 Dose 3 |
| Run-in medications (ICS-LABA combination)During the Run-in Period, the participants are required to maintain on their ICS-LABA dose. Controller medications (eg, ICS LABA) should remain at a stable dose and be taken after study intervention as applicable. These drugs are used as standard of care. | Drug | Part 1 and Part 2: AZD1402 Dose 1, Part 1 and Part 2: AZD1402 Dose 2, Part 1 and Part 2: Placebo, Part 1: AZD1402 Dose 3 |
Primary outcome
Part 1: Number of Participants With Adverse Events (AEs)
Time frame: From Screening (Week -6) until Follow-up (Day 56)
The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.
Part 2: Change From Baseline in Pre-bronchodilator FEV1
Time frame: Baseline and Week 4
The efficacy of inhaled AZD1402 compared to placebo in adults with asthma uncontrolled on medium-to-high dose ICS-LABA was investigated.
Part 1: Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline, Day 12, Day 16, and Day 56
The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.
Part 1: Change From Baseline in FEV1 In-clinic Spirometry
Time frame: Baseline, Day 1, Day 7, Day 14, Day 28, and Day 56
The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.
Part 1: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) (In-clinic)
Time frame: Baseline, Day 1, Day 7, Day 14, Day 28, and Day 56
The safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA was evaluated.
21 secondary outcomes
Part 1 and Part 2: Antidrug Antibodies (ADA) Titers
Time frame: Day 1 until Day 56
Part 1 and Part 2: Maximum Observed Serum (Peak) Drug Concentration (Cmax)
Time frame: Day 1 until Day 56
Part 1 and Part 2: Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz)
Time frame: Day 1 until Day 56
Part 1 and Part 2: Area Under Plasma Concentration-time Curve in the Dosing Interval τ (AUCτ)
Time frame: Day 1 until Day 56
Part 1 and Part 2: Area Under the Plasma Concentration-curve From Zero to the Last Quantifiable Concentration (AUClast)
Time frame: Day 1 until Day 56
Part 1 and Part 2: Observed Lowest Drug Concentration Reached Before the Next Dose is Administered (Pre-dose) (Ctrough)
Time frame: Day 1 until Day 56
Part 1 and Part 2: Terminal Rate Constant, Estimated by Log-linear Least Squares Regression of the Terminal Part of the Concentration-time Curve (λz)
Time frame: Day 1 until Day 56
Part 1 and Part 2: Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on Terminal Phase) (Vz/F)
Time frame: Day 1 until Day 56
Part 1 and Part 2: Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F)
Time frame: Day 1 until Day 56
Part 1 and Part 2: Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax)
Time frame: Day 1 until Day 56
Part 1 and Part 2: Time of Last Observed (Quantifiable) Concentration (Tlast)
Time frame: Day 1 until Day 56
Part 1 and Part 2: Accumulation Ratio for AUCτ (Rac AUC)
Time frame: Day 1 until Day 56
Part 1 and Part 2: Accumulation Ratio for Cmax (Rac Cmax)
Time frame: Day 1 until Day 56
Part 2: Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) at Week 4 and Average Over the Treatment Period
Time frame: Baseline, Week 4
Part 2: Participants With a Decrease in ACQ 6 Score of ≥ 0.5 From Baseline to Week 4
Time frame: Baseline, Week 4
Part 2: Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the Treatment Period
Time frame: Baseline, 4 weeks
Part 2: Change From Baseline in Average Evening PEF Over the Treatment Period
Time frame: Baseline, 4 weeks
Part 2: Change From Baseline in Daily Average Asthma Symptom Score (AM/PM) Over the Treatment Period
Time frame: Baseline, 4 weeks
Part 2: Change From Baseline in Pre-bronchodilator FEV1 Average Over the 4-week Treatment Period
Time frame: Baseline and Week 4
Part 2: Change From Baseline in FeNO (In-clinic) at Week 4 and Average Over the Treatment Period
Time frame: Baseline, Week 4
Part 2: Number of Participants With Adverse Events (AEs)
Time frame: From Screening (Week -6) until Follow-up (Day 56)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CSR SynopsisLink provided by the sponsor.
- CSPLink provided by the sponsor.
- SAPLink provided by the sponsor.
- 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. 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.
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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.
40 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD1402, Short acting beta agonist (SABA) (rescue medication) and Run-in medications (ICS-LABA combination) in people with Asthma, run by AstraZeneca at 40 sites in 10 countries.
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 11 inclusion and 29 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: stopped early, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Germany, South Korea, Poland, United Kingdom, Australia and 5 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Part 1: Number of Participants With Adverse Events (AEs) (time frame: From Screening (Week -6) until Follow-up (Day 56)). The study lists 5 primary outcomes in all. 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 28 Aug 2025.