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Trial record 2 of 2 for:    AZD1402

Efficacy and Safety of Three Inhaled Dose Levels of AZD1402 Administered for Four Weeks in Adults With Asthma on Medium Dose Inhaled Corticosteroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04643158
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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 corticosteroids (ICS)-long acting beta agonists (LABA) before progressing to dosing in adults with asthma who are uncontrolled on medium dose ICS-LABA in Part 2. The study will recruit participants receiving treatment with medium dose ICS with LABA for Part 1 (separate inhalers or combination product) and medium dose ICS-LABA as a combination product for Part 2 at Screening.

Part 2 will be initiated for each dose level following evaluation of safety and PK at the relevant dose level in Part 1. 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.


Condition or disease Intervention/treatment Phase
Asthma Drug: AZD1402 Drug: Placebo Drug: Short acting beta agonist (SABA) (rescue medication) Drug: Run-in medications (ICS-LABA combination) Phase 2

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 360 participants to evaluate 3 inhaled dose levels of AZD1402 versus placebo.

Part 2a, which includes the 2 lower dose levels (Dose 1 and Dose 2) will be started in parallel after the unblinded safety review for Part 1a. The higher dose of Dose 3 (Part 2b) will be included in Part 2 following the unblinded review of Part 1b, depending on the outcome of the safety review. Once Part 2b starts, all 3 dose levels (and placebo) will run in parallel. Part 2 will include:

  • AZD1402 Dose 1
  • AZD1402 Dose 2
  • AZD1402 Dose 3
  • Placebo

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Two-part Phase IIa Randomised, Double-blind, Placebo-controlled, Dose-ranging, Multi-centre Study to Assess Efficacy and Safety of Three Inhaled Dose Levels of AZD1402 Administered as a Dry Powder for Four Weeks in Adults With Asthma on Medium Dose Inhaled Corticosteroids
Actual Study Start Date : March 12, 2021
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Experimental: Part 1 and Part 2: AZD1402 Dose 1
Randomised participants will receive oral inhalation of AZD1402 Dose 1 via DPI.
Drug: AZD1402
Randomised participants will receive oral inhalation of AZD1402, via DPI.

Drug: 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: 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.


Experimental: Part 1 and Part 2: AZD1402 Dose 2
Randomised participants will receive oral inhalation of AZD1402 Dose 2 via DPI.
Drug: AZD1402
Randomised participants will receive oral inhalation of AZD1402, via DPI.

Drug: 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: 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.


Experimental: Part 1 and Part 2: AZD1402 Dose 3
Randomised participants will receive oral inhalation of AZD1402 Dose 3 via DPI.
Drug: AZD1402
Randomised participants will receive oral inhalation of AZD1402, via DPI.

Drug: 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: 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.


Placebo Comparator: Part 1 and Part 2: Placebo
Randomised participants will receive oral inhalation of matching placebo via DPI.
Drug: Placebo
Randomised participants will receive oral inhalation of matching placebo via DPI.

Drug: 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: 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.





Primary Outcome Measures :
  1. Part 1: Number of participants with adverse events (AEs) [ Time Frame: From Day 1 until Follow-up (Day 56 ± 4) ]
    To evaluate the safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA. Safety and tolerability variables included AEs/ adverse events of special interest (AESIs) / serious adverse events (SAEs), vital signs (blood pressure and pulse rate), changes in clinical chemistry, haematology, and coagulation parameters, Immuno-biomarkers, Electrocardiograms (ECGs), Forced expiratory volume in 1 second (FEV1) and fractional exhaled nitric oxide (FeNO).

  2. Part 2: Change from baseline in pre-bronchodilator FEV1 at Week 4 [ Time Frame: Baseline and Week 4 ]
    To investigate the efficacy of inhaled AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.


Secondary Outcome Measures :
  1. Part 1 and Part 2: Maximum observed serum (peak) drug concentration (Cmax) [ Time Frame: Day 1 until Day 56 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  2. 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 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  3. 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 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  4. 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 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  5. 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 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  6. 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 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  7. Part 1 and Part 2: Area under plasma concentration-time curve in the dosing interval (AUCτ) [ Time Frame: Day 1 until Day 56 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  8. 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 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  9. 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 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  10. Part 1 and Part 2: Area under the plasma concentration time curve in the dosing interval τ divided by the dose administered (Dose normalised AUCτ) [ Time Frame: Day 1 until Day 56 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  11. Part 1 and Part 2: Maximum observed plasma (peak) drug concentration divided by the dose administered (Dose normalised Cmax) [ Time Frame: Day 1 until Day 56 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  12. Part 1 and Part 2: Time of last observed (quantifiable) concentration (tlast) [ Time Frame: Day 1 until Day 56 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  13. Part 1 and Part 2: Accumulation ratio for AUCτ (Rac AUC) [ Time Frame: Day 1 until Day 56 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  14. Part 1 and Part 2: Accumulation ratio for Cmax (Rac Cmax) [ Time Frame: Day 1 until Day 56 ± 4 ]
    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  15. Part 1 and Part 2: Antidrug antibodies (ADA) titers testing for all ADA-positive samples as measure of immunogenicity [ Time Frame: Day 1 until Day 56 ± 4 ]
    To investigate the immunogenicity of AZD1402.

  16. Part 2: Change from baseline in pre bronchodilator FEV1 average over the 4-week Treatment Period [ Time Frame: Baseline, 4 weeks ]
    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.

  17. Part 2: Change from baseline in post bronchodilator FEV1 average over the 4-week Treatment Period [ Time Frame: Baseline, 4 weeks ]
    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.

  18. 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 ]
    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. The ACQ was developed to measure asthma control. In the ACQ-6, participants will be asked to recall how their asthma has been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated 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.

  19. Part 2: Proportion of participants with a decrease in ACQ 6 score of ≥ 0.5 from baseline to Week 4 [ Time Frame: Baseline, Week 4 ]
    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. The ACQ was developed to measure asthma control. In the ACQ-6, participants will be asked to recall how their asthma has been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated 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.

  20. Part 2: Change from baseline in St. George's respiratory questionnaire (SGRQ) score to Week 4 [ Time Frame: Baseline, Week 4 ]
    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in asthmatics who are uncontrolled on medium dose ICS-LABA. The SGRQ is a 50-item instrument developed to measure the health status of participants with airway obstruction diseases. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yields a total score and 3 domain scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment.

  21. Part 2: Change from baseline in average morning Peak expiratory flow (PEF) over the Treatment Period [ Time Frame: Baseline, 4 weeks ]
    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Peak expiratory flow will be measured by the participant at home using a peak flow meter.

  22. Part 2: Change from baseline in average evening PEF over the Treatment Period [ Time Frame: Baseline, 4 weeks ]
    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Peak expiratory flow will be measured by the participant at home using a peak flow meter.

  23. Part 2: Change from baseline in daily average asthma symptom score (AM/PM) over the Treatment Period [ Time Frame: Baseline, 4 weeks ]

    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Severity scores for asthma symptoms will be recorded twice daily in the morning and evening and documented in the e-Diary. Asthma symptom scores during night-time and day-time will be 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.


  24. Part 2: Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 4 and average over the Treatment Period [ Time Frame: Baseline, Week 4 ]
    To investigate the effect of AZD1402 compared to placebo on airway inflammation in adults with asthma who are uncontrolled on medium dose ICS-LABA. To investigate the effect of AZD1402 on airway inflammation, the measurement of FeNO will be performed in accordance with ATS/ERS guidelines. Standardised conditions with regard to exhalation flow rate and duration of exhalation will be followed such that plateau definition can be evaluated over a minimum of 3 seconds. The concentration of FeNO will be measured in units of part per billion (ppb).

  25. Part 2: Number of participants with adverse events (AEs) [ Time Frame: From Day 1 until the Follow-up (Day 56 ± 4) ]
    To evaluate the safety and tolerability of AZD1402 compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Safety and tolerability variables included AEs/AESIs/SAEs, vital signs (blood pressure and pulse rate), changes in clinical chemistry, haematology, and coagulation parameters, Immuno-biomarkers, ECGs, FEV1 and FeNO.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.
  • Participant's influenza/pneumonia vaccination is up to date as per local guidelines.
  • 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 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: Demonstration of reversibility to inhaled bronchodilators at Screening. Documented treatment with medium dose ICS-LABA for at least 12 months prior to Screening. If on asthma maintenance controller medications in addition to ICS-LABA, the dose of the additional controller medications must be stable for at least 3 months prior to Screening. Have had at least one severe asthma exacerbation in the 12 months prior to Screening. Pre bronchodilator FEV1 of 60% to 80% (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.
  • For Part 2: Pre-bronchodilator FEV1 of 60% to 80% (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 80% compliance with ePRO completion. C-reactive protein < 5 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.
  • Clinically important pulmonary disease other than asthma.
  • History or clinical suspicion of any clinically relevant or active disease or disorder.
  • Diagnosis of / suspected COVID-19 infection with associated pneumonia / pneumonitis.
  • Participants with a positive test result for COVID-19.
  • History of cancer within the last 10 years, any history of lymphoma or lung cancer is strictly exclusionary.
  • 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, including hepatitis B or C, human immunodeficiency virus (HIV), 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. Pre-bronchodilator FEV1 decrease or increase ≥ 20%. 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-participant 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, 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 and during Run-in.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643158


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Australia
Research Site Not yet recruiting
Herston, Australia, 4006
Research Site Not yet recruiting
Melbourne, Australia, IC 3004
Research Site Recruiting
Nedlands, Australia, 6009
Germany
Research Site Not yet recruiting
Berlin, Germany, 14050
Research Site Not yet recruiting
Frankfurt, Germany, 60596
Research Site Not yet recruiting
Mainz, Germany, 55128
Ukraine
Research Site Recruiting
Kiev, Ukraine, 02000
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04643158    
Other Study ID Numbers: D2912C00003
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in a sponsor approved tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
AZD1402
placebo
Anticalin® protein
dry powder inhaler
inhaled corticosteroids
efficacy
safety
Additional relevant MeSH terms:
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Asthma
Respiratory Aspiration
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Pathologic Processes