Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids
NCT ID: NCT04643158
Last Updated: 2025-08-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
72 participants
INTERVENTIONAL
2021-03-12
2023-07-20
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part 1 and Part 2: AZD1402 Dose 1
Randomised participants will receive oral inhalation of AZD1402 Dose 1 via DPI.
AZD1402
Randomised participants will receive oral inhalation of AZD1402, via DPI.
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)
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.
Part 1 and Part 2: AZD1402 Dose 2
Randomised participants will receive oral inhalation of AZD1402 Dose 2 via DPI.
AZD1402
Randomised participants will receive oral inhalation of AZD1402, via DPI.
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)
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.
Part 1: AZD1402 Dose 3
Randomised participants will receive oral inhalation of AZD1402 Dose 3 via DPI.
AZD1402
Randomised participants will receive oral inhalation of AZD1402, via DPI.
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)
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.
Part 1 and Part 2: Placebo
Randomised participants will receive oral inhalation of matching placebo via DPI.
Placebo
Randomised participants will receive oral inhalation of matching placebo via DPI.
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)
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.
Interventions
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AZD1402
Randomised participants will receive oral inhalation of AZD1402, via DPI.
Placebo
Randomised participants will receive oral inhalation of matching placebo via DPI.
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)
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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).
* 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.
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Herston, , Australia
Research Site
Melbourne, , Australia
Research Site
Nedlands, , Australia
Research Site
Windsor, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Bonn, , Germany
Research Site
Frankfurt, , Germany
Research Site
Hamburg, , Germany
Research Site
Hanover, , Germany
Research Site
Lübeck, , Germany
Research Site
Csorna, , Hungary
Research Site
Szombathely, , Hungary
Research Site
Bialystok, , Poland
Research Site
Krakow, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Lubin, , Poland
Research Site
Sopot, , Poland
Research Site
Wroclaw, , Poland
Research Site
Cheongiu, , South Korea
Research Site
Incheon, , South Korea
Research Site
Namdong-gu, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Barcelona, , Spain
Research Site
Santiago de Compostela, , Spain
Research Site
Villarreal, , Spain
Research Site
Kaohsiung City, , Taiwan
Research Site
Kiev, , Ukraine
Research Site
High Wycombe, , United Kingdom
Research Site
Liverpool, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2020-002828-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D2912C00003
Identifier Type: -
Identifier Source: org_study_id
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